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"Description": "Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
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"Description": "Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
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"Description": "Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
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"Description": "Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
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"Description": "Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
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"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. 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 hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 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. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
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"Description": "Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
},
{
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"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. 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 hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 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. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
},
{
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"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. 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 hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 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. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
},
{
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"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. 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 hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 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. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "87063-048-60",
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"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. 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 hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 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. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "87063-048-90",
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"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. 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 hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 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. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "87063-287-09",
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"ProprietaryName": "Naratriptan",
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"StartMarketingDate": "20110315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200502",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
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"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide."
},
{
"NDCCode": "87063-287-12",
"PackageDescription": "12 TABLET in 1 BOTTLE (87063-287-12) ",
"NDC11Code": "87063-0287-12",
"ProductNDC": "87063-287",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
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"DosageFormName": "TABLET",
"RouteName": "ORAL",
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"ApplicationNumber": "ANDA200502",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260807",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide."
},
{
"NDCCode": "87063-287-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (87063-287-30) ",
"NDC11Code": "87063-0287-30",
"ProductNDC": "87063-287",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200502",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260807",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide."
},
{
"NDCCode": "87063-287-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (87063-287-60) ",
"NDC11Code": "87063-0287-60",
"ProductNDC": "87063-287",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200502",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260807",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide."
},
{
"NDCCode": "87063-287-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (87063-287-90) ",
"NDC11Code": "87063-0287-90",
"ProductNDC": "87063-287",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200502",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260807",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide."
},
{
"NDCCode": "87063-288-09",
"PackageDescription": "9 TABLET in 1 BLISTER PACK (87063-288-09) ",
"NDC11Code": "87063-0288-09",
"ProductNDC": "87063-288",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200502",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260807",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide."
},
{
"NDCCode": "87063-288-12",
"PackageDescription": "12 TABLET in 1 BOTTLE (87063-288-12) ",
"NDC11Code": "87063-0288-12",
"ProductNDC": "87063-288",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200502",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260807",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide."
},
{
"NDCCode": "87063-288-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (87063-288-30) ",
"NDC11Code": "87063-0288-30",
"ProductNDC": "87063-288",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200502",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260807",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide."
},
{
"NDCCode": "87063-288-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (87063-288-60) ",
"NDC11Code": "87063-0288-60",
"ProductNDC": "87063-288",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200502",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260807",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide."
},
{
"NDCCode": "87063-288-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (87063-288-90) ",
"NDC11Code": "87063-0288-90",
"ProductNDC": "87063-288",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200502",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260807",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide."
},
{
"NDCCode": "87063-014-00",
"PackageDescription": "1000 TABLET in 1 BOTTLE (87063-014-00) ",
"NDC11Code": "87063-0014-00",
"ProductNDC": "87063-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040596",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251017",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C 17H 20N 2S HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N, N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate."
},
{
"NDCCode": "87063-014-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (87063-014-01) ",
"NDC11Code": "87063-0014-01",
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<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. 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 hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 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. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. 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 hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 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. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. 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 hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 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. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. 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 hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 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. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. 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 hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 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. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. 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 hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 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. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. 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 hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 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. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. 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 hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 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. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
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<PackageDescription>60 TABLET in 1 BOTTLE (87063-048-60) </PackageDescription>
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<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. 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 hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 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. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
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<NDCCode>87063-048-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (87063-048-90) </PackageDescription>
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<ProductNDC>87063-048</ProductNDC>
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<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. 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 hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 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. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:. C 21H 26O 5M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
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<NDCCode>87063-287-09</NDCCode>
<PackageDescription>9 TABLET in 1 BLISTER PACK (87063-287-09) </PackageDescription>
<NDC11Code>87063-0287-09</NDC11Code>
<ProductNDC>87063-287</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200502</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
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<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide.</Description>
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<PackageDescription>12 TABLET in 1 BOTTLE (87063-287-12) </PackageDescription>
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<ApplicationNumber>ANDA200502</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>87063-287-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (87063-287-30) </PackageDescription>
<NDC11Code>87063-0287-30</NDC11Code>
<ProductNDC>87063-287</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200502</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>87063-287-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (87063-287-60) </PackageDescription>
<NDC11Code>87063-0287-60</NDC11Code>
<ProductNDC>87063-287</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200502</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>87063-287-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (87063-287-90) </PackageDescription>
<NDC11Code>87063-0287-90</NDC11Code>
<ProductNDC>87063-287</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200502</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>87063-288-09</NDCCode>
<PackageDescription>9 TABLET in 1 BLISTER PACK (87063-288-09) </PackageDescription>
<NDC11Code>87063-0288-09</NDC11Code>
<ProductNDC>87063-288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200502</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>87063-288-12</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE (87063-288-12) </PackageDescription>
<NDC11Code>87063-0288-12</NDC11Code>
<ProductNDC>87063-288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200502</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>87063-288-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (87063-288-30) </PackageDescription>
<NDC11Code>87063-0288-30</NDC11Code>
<ProductNDC>87063-288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200502</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>87063-288-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (87063-288-60) </PackageDescription>
<NDC11Code>87063-0288-60</NDC11Code>
<ProductNDC>87063-288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200502</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>87063-288-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (87063-288-90) </PackageDescription>
<NDC11Code>87063-0288-90</NDC11Code>
<ProductNDC>87063-288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200502</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>87063-014-00</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (87063-014-00) </PackageDescription>
<NDC11Code>87063-0014-00</NDC11Code>
<ProductNDC>87063-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C 17H 20N 2S HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N, N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
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<NDC>
<NDCCode>87063-014-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (87063-014-01) </PackageDescription>
<NDC11Code>87063-0014-01</NDC11Code>
<ProductNDC>87063-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
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<LabelerName>ASCLEMED USA INC.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
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<LastUpdate>2026-07-04</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C 17H 20N 2S HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N, N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>87063-014-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (87063-014-05) </PackageDescription>
<NDC11Code>87063-0014-05</NDC11Code>
<ProductNDC>87063-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C 17H 20N 2S HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N, N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>87063-014-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (87063-014-10) </PackageDescription>
<NDC11Code>87063-0014-10</NDC11Code>
<ProductNDC>87063-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C 17H 20N 2S HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N, N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>87063-014-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (87063-014-20) </PackageDescription>
<NDC11Code>87063-0014-20</NDC11Code>
<ProductNDC>87063-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C 17H 20N 2S HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N, N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>87063-014-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (87063-014-30) </PackageDescription>
<NDC11Code>87063-0014-30</NDC11Code>
<ProductNDC>87063-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C 17H 20N 2S HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N, N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>87063-014-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (87063-014-60) </PackageDescription>
<NDC11Code>87063-0014-60</NDC11Code>
<ProductNDC>87063-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C 17H 20N 2S HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N, N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>87063-014-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (87063-014-90) </PackageDescription>
<NDC11Code>87063-0014-90</NDC11Code>
<ProductNDC>87063-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
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<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C 17H 20N 2S HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N, N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
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