RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "70404-077-16",
      "PackageDescription": "480 mL in 1 BOTTLE (70404-077-16) ",
      "NDC11Code": "70404-0077-16",
      "ProductNDC": "70404-077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisolone",
      "NonProprietaryName": "Prednisolone Oral",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260708",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219509",
      "LabelerName": "Tulex Pharmaceuticals Inc",
      "SubstanceName": "PREDNISOLONE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260708",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prednisolone Oral Solution, USP is indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).    Congenital adrenal hyperplasia    Nonsuppurative thyroiditis    Hypercalcemia associated with cancer. 2. 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. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of.    Systemic lupus erythematosus    Acute rheumatic carditis. 4. Dermatologic Diseases.    Pemphigus    Bullous dermatitis herpetiformis    Severe erythema multiforme (Stevens-Johnson syndrome)    Exfoliative dermatitis    Mycosis fungoides    Severe psoriasis    Severe seborrheic dermatitis. 5. 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. 6. 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. 7. Respiratory Diseases. Symptomatic sarcoidosis Loeffler’s syndrome not manageable by other means.    Berylliosis    Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy    Aspiration pneumonitis. 8. Hematologic Disorders.    Idiopathic thrombocytopenic purpura in adults    Secondary thrombocytopenia in adults    Acquired (autoimmune) hemolytic anemia    Erythroblastopenia (RBC anemia)    Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of.    Acute leukemia of childhood    Leukemias and lymphomas in adults. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in.    Ulcerative colitis    Regional enteritis. 12. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement. In addition to the above indications prednisolone oral solution is indicated for systemic dermatomyositis (polymyositis).",
      "Description": "Prednisolone oral solution, USP contains prednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisolone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water, soluble in methanol and in dioxane; sparingly soluble in acetone and in alcohol, slightly soluble in chloroform. The chemical name for Prednisolone is Pregna-1,4 -diene -3, 20 - dione, 11, 17, 21- trihydroxy-,(11β). Its molecular weight is 360.45. The molecular formula is C 21H 28O 5 and the structural formula is:. Prednisolone oral solution contains 15 mg of prednisolone in each 5 mL. Benzoic acid, 0.1% is added as a preservative. It also contains ethyl alcohol 5% (v/v), ethyl maltol, glycerin, propylene glycol, purified water, sucralose, berry mixed flavor and FD&C red #40."
    },
    {
      "NDCCode": "70404-077-14",
      "PackageDescription": "240 mL in 1 BOTTLE (70404-077-14) ",
      "NDC11Code": "70404-0077-14",
      "ProductNDC": "70404-077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisolone",
      "NonProprietaryName": "Prednisolone Oral",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260708",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219509",
      "LabelerName": "Tulex Pharmaceuticals Inc",
      "SubstanceName": "PREDNISOLONE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260708",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prednisolone Oral Solution, USP is indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).    Congenital adrenal hyperplasia    Nonsuppurative thyroiditis    Hypercalcemia associated with cancer. 2. 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. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of.    Systemic lupus erythematosus    Acute rheumatic carditis. 4. Dermatologic Diseases.    Pemphigus    Bullous dermatitis herpetiformis    Severe erythema multiforme (Stevens-Johnson syndrome)    Exfoliative dermatitis    Mycosis fungoides    Severe psoriasis    Severe seborrheic dermatitis. 5. 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. 6. 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. 7. Respiratory Diseases. Symptomatic sarcoidosis Loeffler’s syndrome not manageable by other means.    Berylliosis    Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy    Aspiration pneumonitis. 8. Hematologic Disorders.    Idiopathic thrombocytopenic purpura in adults    Secondary thrombocytopenia in adults    Acquired (autoimmune) hemolytic anemia    Erythroblastopenia (RBC anemia)    Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of.    Acute leukemia of childhood    Leukemias and lymphomas in adults. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in.    Ulcerative colitis    Regional enteritis. 12. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement. In addition to the above indications prednisolone oral solution is indicated for systemic dermatomyositis (polymyositis).",
      "Description": "Prednisolone oral solution, USP contains prednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisolone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water, soluble in methanol and in dioxane; sparingly soluble in acetone and in alcohol, slightly soluble in chloroform. The chemical name for Prednisolone is Pregna-1,4 -diene -3, 20 - dione, 11, 17, 21- trihydroxy-,(11β). Its molecular weight is 360.45. The molecular formula is C 21H 28O 5 and the structural formula is:. Prednisolone oral solution contains 15 mg of prednisolone in each 5 mL. Benzoic acid, 0.1% is added as a preservative. It also contains ethyl alcohol 5% (v/v), ethyl maltol, glycerin, propylene glycol, purified water, sucralose, berry mixed flavor and FD&C red #40."
    },
    {
      "NDCCode": "36800-077-16",
      "PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (36800-077-16) ",
      "NDC11Code": "36800-0077-16",
      "ProductNDC": "36800-077",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Isopropyl Alcohol",
      "ProprietaryNameSuffix": "91 Percent",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141031",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "TOP CARE (Topco Associates LLC)",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "91",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2025-04-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20141031",
      "SamplePackage": "N",
      "IndicationAndUsage": "first aid to help prevent the risk of infection in minor cuts, scrapes and burns."
    },
    {
      "NDCCode": "52959-077-16",
      "PackageDescription": "16 TABLET in 1 BOTTLE (52959-077-16)",
      "NDC11Code": "52959-0077-16",
      "ProductNDC": "52959-077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ibuprofen",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091123",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078558",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "800",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.",
      "Description": "Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid.  Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide."
    },
    {
      "NDCCode": "68382-077-16",
      "PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-077-16) ",
      "NDC11Code": "68382-0077-16",
      "ProductNDC": "68382-077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fenofibric Acid",
      "NonProprietaryName": "Fenofibric Acid",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20081215",
      "EndMarketingDate": "20190323",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA022224",
      "LabelerName": "Zydus Pharmaceuticals USA Inc",
      "SubstanceName": "FENOFIBRIC ACID",
      "StrengthNumber": "45",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-03-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20081215",
      "EndMarketingDatePackage": "20190323",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69804-077-16",
      "PackageDescription": "113400 mg in 1 BOTTLE, DISPENSING (69804-077-16) ",
      "NDC11Code": "69804-0077-16",
      "ProductNDC": "69804-077",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sore Relief",
      "NonProprietaryName": "Lidocaine Hcl",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20171127",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "ridge properties llc",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1000mg",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20171127",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "83022-077-16",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (83022-077-16)  / 30 g in 1 BOTTLE, PUMP",
      "NDC11Code": "83022-0077-16",
      "ProductNDC": "83022-077",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "White Tea Tinted Moisturizer",
      "NonProprietaryName": "White Tea Tinted Moisturizer Broad Spectrum Spf 30 Sunscreen",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20221021",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "GLOW CONCEPT INC",
      "SubstanceName": "HOMOSALATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "10; 3; 5; 7",
      "StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2025-12-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221021",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "14222-8010-1",
      "PackageDescription": "1 TUBE in 1 CARTON (14222-8010-1)  / 40 mL in 1 TUBE",
      "NDC11Code": "14222-8010-01",
      "ProductNDC": "14222-8010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Recharge Protect Blur",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20251114",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Rodan & Fields Beauty, LLC",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": ".032; .077",
      "StrengthUnit": "g/mL; g/mL",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "42291-077-15",
      "PackageDescription": "1 TUBE in 1 CARTON (42291-077-15)  / 15 g in 1 TUBE",
      "NDC11Code": "42291-0077-15",
      "ProductNDC": "42291-077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clobetasol Propionate",
      "NonProprietaryName": "Clobetasol Propionate",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200618",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209701",
      "LabelerName": "AvKARE",
      "SubstanceName": "CLOBETASOL PROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-07-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200618",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clobetasol Propionate Ointment USP is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
      "Description": "Clobetasol Propionate Ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C 25H 32ClFO 5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water; slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
    },
    {
      "NDCCode": "42291-077-30",
      "PackageDescription": "1 TUBE in 1 CARTON (42291-077-30)  / 30 g in 1 TUBE",
      "NDC11Code": "42291-0077-30",
      "ProductNDC": "42291-077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clobetasol Propionate",
      "NonProprietaryName": "Clobetasol Propionate",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200618",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209701",
      "LabelerName": "AvKARE",
      "SubstanceName": "CLOBETASOL PROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-07-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200618",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clobetasol Propionate Ointment USP is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
      "Description": "Clobetasol Propionate Ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C 25H 32ClFO 5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water; slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
    },
    {
      "NDCCode": "42291-077-45",
      "PackageDescription": "1 TUBE in 1 CARTON (42291-077-45)  / 45 g in 1 TUBE",
      "NDC11Code": "42291-0077-45",
      "ProductNDC": "42291-077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clobetasol Propionate",
      "NonProprietaryName": "Clobetasol Propionate",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200618",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209701",
      "LabelerName": "AvKARE",
      "SubstanceName": "CLOBETASOL PROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-07-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200618",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clobetasol Propionate Ointment USP is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
      "Description": "Clobetasol Propionate Ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C 25H 32ClFO 5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water; slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
    },
    {
      "NDCCode": "42291-077-60",
      "PackageDescription": "1 TUBE in 1 CARTON (42291-077-60)  / 60 g in 1 TUBE",
      "NDC11Code": "42291-0077-60",
      "ProductNDC": "42291-077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clobetasol Propionate",
      "NonProprietaryName": "Clobetasol Propionate",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200618",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209701",
      "LabelerName": "AvKARE",
      "SubstanceName": "CLOBETASOL PROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-07-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200618",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clobetasol Propionate Ointment USP is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
      "Description": "Clobetasol Propionate Ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C 25H 32ClFO 5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water; slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
    },
    {
      "NDCCode": "42851-077-56",
      "PackageDescription": "1 TUBE in 1 CARTON (42851-077-56)  > 56.5 g in 1 TUBE",
      "NDC11Code": "42851-0077-56",
      "ProductNDC": "42851-077",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Vitascrub Invigorating Foaming Scrub",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130517",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "ZO Skin Health, Inc.",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2015-01-16"
    },
    {
      "NDCCode": "42851-077-98",
      "PackageDescription": "1 TUBE in 1 CARTON (42851-077-98)  > 113 g in 1 TUBE",
      "NDC11Code": "42851-0077-98",
      "ProductNDC": "42851-077",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Vitascrub Invigorating Foaming Scrub",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130517",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "ZO Skin Health, Inc.",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2015-01-16"
    },
    {
      "NDCCode": "55910-077-32",
      "PackageDescription": "32 TABLET, CHEWABLE in 1 BOTTLE (55910-077-32) ",
      "NDC11Code": "55910-0077-32",
      "ProductNDC": "55910-077",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Heartburn And Gas Antacid Chews",
      "NonProprietaryName": "Calcium Carbonate",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170228",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M001",
      "LabelerName": "DOLGENCORP, LLC",
      "SubstanceName": "CALCIUM CARBONATE; DIMETHICONE",
      "StrengthNumber": "750; 80",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Skin Barrier Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20170228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: Relieves. Heartburn. Sour stomach. Acid indigestion. Upset stomach associated with these symptoms. Bloating, pressure or stuffed feeling commonly referred to as gas."
    },
    {
      "NDCCode": "69423-077-73",
      "PackageDescription": "73 g in 1 CYLINDER (69423-077-73)",
      "NDC11Code": "69423-0077-73",
      "ProductNDC": "69423-077",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Secret Capri Island Retreat Clear",
      "NonProprietaryName": "Aluminum Zirconium Octachlorohydrex Gly",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160110",
      "EndMarketingDate": "20181007",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "The Procter and Gamble Manufacturing Company",
      "SubstanceName": "ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY",
      "StrengthNumber": "16",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2018-10-10",
      "ProductNdcExcludeFlag": "N"
    },
    {
      "NDCCode": "71209-077-01",
      "PackageDescription": "30 TABLET in 1 BOTTLE (71209-077-01) ",
      "NDC11Code": "71209-0077-01",
      "ProductNDC": "71209-077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olanzapine",
      "NonProprietaryName": "Olanzapine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190213",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210022",
      "LabelerName": "Cadila Pharmaceuticals Limited",
      "SubstanceName": "OLANZAPINE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190213",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:As oral formulation for the:  Treatment of schizophrenia. (1.1)  Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)  Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1)  Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)  Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)  Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2)  Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3)  Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)  Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine IntraMuscular for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) Efficacy was established in three 1-day trials in adults. (14.3)As Olanzapine and Fluoxetine in Combination for the:  Treatment of depressive episodes associated with bipolar I disorder. (1.5)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.  Treatment of treatment resistant depression. (1.6)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
      "Description": "Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each film-coated tablet contains olanzapine, USP equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH101) and microcrystalline cellulose (Avicel PH102). The color coating contains hypromellose, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "71209-077-05",
      "PackageDescription": "100 TABLET in 1 BOTTLE (71209-077-05) ",
      "NDC11Code": "71209-0077-05",
      "ProductNDC": "71209-077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olanzapine",
      "NonProprietaryName": "Olanzapine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190213",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210022",
      "LabelerName": "Cadila Pharmaceuticals Limited",
      "SubstanceName": "OLANZAPINE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231004",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:As oral formulation for the:  Treatment of schizophrenia. (1.1)  Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)  Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1)  Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)  Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)  Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2)  Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3)  Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)  Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine IntraMuscular for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) Efficacy was established in three 1-day trials in adults. (14.3)As Olanzapine and Fluoxetine in Combination for the:  Treatment of depressive episodes associated with bipolar I disorder. (1.5)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.  Treatment of treatment resistant depression. (1.6)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
      "Description": "Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each film-coated tablet contains olanzapine, USP equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH101) and microcrystalline cellulose (Avicel PH102). The color coating contains hypromellose, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "71209-077-10",
      "PackageDescription": "500 TABLET in 1 BOTTLE (71209-077-10) ",
      "NDC11Code": "71209-0077-10",
      "ProductNDC": "71209-077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olanzapine",
      "NonProprietaryName": "Olanzapine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190213",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210022",
      "LabelerName": "Cadila Pharmaceuticals Limited",
      "SubstanceName": "OLANZAPINE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231004",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:As oral formulation for the:  Treatment of schizophrenia. (1.1)  Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)  Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1)  Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)  Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)  Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2)  Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3)  Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)  Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine IntraMuscular for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) Efficacy was established in three 1-day trials in adults. (14.3)As Olanzapine and Fluoxetine in Combination for the:  Treatment of depressive episodes associated with bipolar I disorder. (1.5)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.  Treatment of treatment resistant depression. (1.6)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
      "Description": "Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each film-coated tablet contains olanzapine, USP equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH101) and microcrystalline cellulose (Avicel PH102). The color coating contains hypromellose, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "71209-077-11",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (71209-077-11) ",
      "NDC11Code": "71209-0077-11",
      "ProductNDC": "71209-077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olanzapine",
      "NonProprietaryName": "Olanzapine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190213",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210022",
      "LabelerName": "Cadila Pharmaceuticals Limited",
      "SubstanceName": "OLANZAPINE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190213",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:As oral formulation for the:  Treatment of schizophrenia. (1.1)  Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)  Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1)  Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)  Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)  Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2)  Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3)  Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)  Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine IntraMuscular for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) Efficacy was established in three 1-day trials in adults. (14.3)As Olanzapine and Fluoxetine in Combination for the:  Treatment of depressive episodes associated with bipolar I disorder. (1.5)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.  Treatment of treatment resistant depression. (1.6)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
      "Description": "Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each film-coated tablet contains olanzapine, USP equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH101) and microcrystalline cellulose (Avicel PH102). The color coating contains hypromellose, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "76420-077-01",
      "PackageDescription": "1 mL in 1 VIAL, SINGLE-DOSE (76420-077-01) ",
      "NDC11Code": "76420-0077-01",
      "ProductNDC": "76420-077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexamethasone Sodium Phosphate",
      "NonProprietaryName": "Dexamethasone Sodium Phosphate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE",
      "StartMarketingDate": "20200211",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206781",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "DEXAMETHASONE SODIUM PHOSPHATE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-10-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200211",
      "SamplePackage": "N",
      "IndicationAndUsage": "A. Intravenous or intramuscular administration. When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows:. 1. Endocrine disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2.Rheumatic disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute and subacute bursitis. Epicondylitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Psoriatic arthritis. Ankylosing spondylitis. 3.     Collagen diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Acute rheumatic carditis. 4.    Dermatologic diseases. Pemphigus. Severe erythema multiforme (Stevens-Johnson Syndrome). Exfoliative dermatitis. Bullous dermatitis herpetiformis. Severe seborrheic dermatitis. Severe psoriasis. Mycosis fungoides. 5.     Allergic states. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Seasonal or perennial allergic rhinitis. Drug hypersensitivity reactions. Urticarial transfusion reactions. Acute noninfectious laryngeal edema (epinephrine is the drug of first choice). 6.    Ophthalmic diseases. Severe acute and chronic allergic and inflammatory processes involving the eye, such as:. Herpes zoster ophthalmicus. Iritis, iridocyclitis. Chorioretinitis. Diffuse posterior uveitis and choroiditis. Optic neuritis. Sympathetic ophthalmia. Anterior segment inflammation. Allergic conjunctivitis. Allergic corneal marginal ulcers. Keratitis. 7.   Gastrointestinal diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis (systemic therapy). Regional enteritis (systemic therapy). 8.   Respiratory diseases:. Symptomatic Sarcoidosis. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculosis chemotherapy. Loeffler's syndrome not manageable by other means. Aspiration pneumonitis. 9.  Hematologic disorders:. Acquired (autoimmune) hemolytic anemia. Idiopathic thrombocytopenic purpura in adults (I.V. only; I.M. administration is contraindicated). Secondary thrombocytopenia in adults. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 10. Neoplastic diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemia of childhood. 11. Edematous states. To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 12. Nervous system. Acute exacerbations of multiple sclerosis . 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculosis chemotherapy. Trichinosis with neurologic or myocardial involvement. Diagnostic testing of adrenocortical hyperfunction. Cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management. B. Intra-articular or soft tissue administration. When the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intra-articular or soft tissue administration are indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Synovitis of osteoarthritis. Rheumatoid arthritis. Acute and subacute bursitis. Acute gouty arthritis. Epicondylitis. Acute nonspecific tenosynovitis. Post-traumatic osteoarthritis. C. Intralesional administration. When the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intralesional administration are indicated for:. Keloids. Localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis). Discoid lupus erythematosus. Necrobiosis lipoidica diabeticorum. Alopecia areata. They also may be useful in cystic tumors of an aponeurosis tendon (ganglia).",
      "Description": "Dexamethasone sodium phosphate injection USP is a sterile, clear, colorless solution, free from visible particles and a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate USP, C 22H 28FNa 2O 8P, has a molecular weight of 516.41 and chemically is Pregn-4-ene-3, 20-dione, 9-fluoro-11, 17-dihydroxy-16-methyl-21 (phosphonooxy)-, disodium salt, (11β, 16α). It occurs as a white to practically white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.0 and 8.5. It has the following structural formula: Dexamethasone sodium phosphate injection USP is available in 4 mg/mL concentration. Each mL of dexamethasone sodium phosphate injection USP, 4 mg/mL, contains 4.37 mg of dexamethasone sodium phosphate, USP equivalent to 4 mg dexamethasone phosphate; 1 mg sodium sulfite; 10 mg benzyl alcohol (preservative). Made isotonic with sodium citrate. pH adjusted with citric acid or sodium hydroxide. ACTIONS — Naturally occurring glucocorticoids (hydrocortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli."
    },
    {
      "NDCCode": "87063-077-05",
      "PackageDescription": "1 VIAL in 1 CARTON (87063-077-05)  / 5 mL in 1 VIAL",
      "NDC11Code": "87063-0077-05",
      "ProductNDC": "87063-077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Triamcinolone Acetonide",
      "NonProprietaryName": "Triamcinolone Acetonide",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRA-ARTICULAR; INTRAMUSCULAR",
      "StartMarketingDate": "20191119",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207550",
      "LabelerName": "ASCLEMED USA INC.",
      "SubstanceName": "TRIAMCINOLONE ACETONIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260120",
      "SamplePackage": "N",
      "IndicationAndUsage": "Intramuscular. Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension is indicated for intramuscular useas follows:. Allergic states:Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases:Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders:Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of 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. Gastrointestinal diseases:To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders:Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous:Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases:For the palliative management of leukemias and lymphomas. Nervous system:Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases:Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases:To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases:Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders:As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis and systemic lupus erythematosus. Intra-Articular. The intra-articular or soft tissue administrationof triamcinolone acetonide injectable suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.",
      "Description": "Triamcinolone acetonide injectable suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION. Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, USP, with 0.65% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and 0.04% polysorbate 80 in an aqueous suspension. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. Triamcinolone acetonide, USP occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol."
    },
    {
      "NDCCode": "70404-006-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (70404-006-01) ",
      "NDC11Code": "70404-0006-01",
      "ProductNDC": "70404-006",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxybutynin Chloride",
      "NonProprietaryName": "Oxybutynin Chloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210125",
      "LabelerName": "Tulex Pharmaceuticals, Inc.",
      "SubstanceName": "OXYBUTYNIN CHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-10-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20170101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70404-006-03",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (70404-006-03) ",
      "NDC11Code": "70404-0006-03",
      "ProductNDC": "70404-006",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxybutynin Chloride",
      "NonProprietaryName": "Oxybutynin Chloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210125",
      "LabelerName": "Tulex Pharmaceuticals, Inc.",
      "SubstanceName": "OXYBUTYNIN CHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-10-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20170101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70404-006-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (70404-006-05) ",
      "NDC11Code": "70404-0006-05",
      "ProductNDC": "70404-006",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxybutynin Chloride",
      "NonProprietaryName": "Oxybutynin Chloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210125",
      "LabelerName": "Tulex Pharmaceuticals, Inc.",
      "SubstanceName": "OXYBUTYNIN CHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-10-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20170101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0096-0688-04",
      "PackageDescription": "115 g in 1 BOTTLE (0096-0688-04) ",
      "NDC11Code": "00096-0688-04",
      "ProductNDC": "0096-0688",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Solbar Zinc Spf38",
      "NonProprietaryName": "Solbar Zinc Spf38",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19960601",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Person and Covey",
      "SubstanceName": "HOMOSALATE; OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": ".1015; .077; .077",
      "StrengthUnit": "g/g; g/g; g/g",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Active",
      "LastUpdate": "2026-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19960601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "10544-077-06",
      "PackageDescription": "6 TABLET in 1 BOTTLE (10544-077-06)",
      "NDC11Code": "10544-0077-06",
      "ProductNDC": "10544-077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenazopyridine Hcl",
      "NonProprietaryName": "Phenazopyridine Hcl",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120606",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency frequency, and other discomforts arising from irritation of the mucosa of the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of phenazopyridine for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. The drug should be used for symptomatic relief of pain and not as a substitute for specific surgery or antimicrobial therapy. Phenazopyridine is compatible with antimicrobial therapy and can help relieve pain and discomfort during the interval before antimicrobial therapy controls the infection. Treatment of a urinary tract infection with phenazopyridine should not exceed 2 days. There is no evidence that the combined administration of phenazopyridine and an antimicrobial provides greater benefit than administration of the antimicrobial alone after 2 days. (See Dosage and Administration.).",
      "Description": "Phenazopyridine Hydrochloride is a reddish-brown, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. Following is the structural formula. Phenazopyridine HCl tablets contain the following inactive ingredients: Corn Starch, Croscarmellose Sodium, Hypromellose, Light Mineral Oil, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Pregelatinized Starch, and Silicon Dioxide."
    },
    {
      "NDCCode": "10544-077-09",
      "PackageDescription": "9 TABLET in 1 BOTTLE (10544-077-09)",
      "NDC11Code": "10544-0077-09",
      "ProductNDC": "10544-077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenazopyridine Hcl",
      "NonProprietaryName": "Phenazopyridine Hcl",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120606",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency frequency, and other discomforts arising from irritation of the mucosa of the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of phenazopyridine for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. The drug should be used for symptomatic relief of pain and not as a substitute for specific surgery or antimicrobial therapy. Phenazopyridine is compatible with antimicrobial therapy and can help relieve pain and discomfort during the interval before antimicrobial therapy controls the infection. Treatment of a urinary tract infection with phenazopyridine should not exceed 2 days. There is no evidence that the combined administration of phenazopyridine and an antimicrobial provides greater benefit than administration of the antimicrobial alone after 2 days. (See Dosage and Administration.).",
      "Description": "Phenazopyridine Hydrochloride is a reddish-brown, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. Following is the structural formula. Phenazopyridine HCl tablets contain the following inactive ingredients: Corn Starch, Croscarmellose Sodium, Hypromellose, Light Mineral Oil, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Pregelatinized Starch, and Silicon Dioxide."
    },
    {
      "NDCCode": "10702-077-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (10702-077-01) ",
      "NDC11Code": "10702-0077-01",
      "ProductNDC": "10702-077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phendimetrazine Tartrate",
      "NonProprietaryName": "Phendimetrazine Tartrate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100915",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091042",
      "LabelerName": "KVK-TECH, INC",
      "SubstanceName": "PHENDIMETRAZINE TARTRATE",
      "StrengthNumber": "35",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
      "DEASchedule": "CIII",
      "Status": "Active",
      "LastUpdate": "2024-12-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100915",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phendimetrazine tartrate is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. Phendimetrazine tartrate is indicated for use as monotherapy only.",
      "Description": "Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2S,3S)-3,4-Dimethyl-2-phenylmorpholine L-(+)- tartrate (1:1). The structural formula is. Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene. Each white tablet, for oral administration, contains 35 mg of phendimetrazine tartrate. In addition, the following inactive ingredients are present: Colloidal Silicon Dioxide, Lactose Monohydrate, Microcrystalline Cellulose 102, Sodium Starch Glycolate and Stearic Acid. The yellow tablet also contains FD&C Yellow # 5 Aluminum Lake (15-17%). The blue tablet also contains FD&C Blue # 1 Aluminum Lake (11-13%)."
    },
    {
      "NDCCode": "10702-077-03",
      "PackageDescription": "30 TABLET in 1 BOTTLE (10702-077-03) ",
      "NDC11Code": "10702-0077-03",
      "ProductNDC": "10702-077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phendimetrazine Tartrate",
      "NonProprietaryName": "Phendimetrazine Tartrate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100915",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091042",
      "LabelerName": "KVK-TECH, INC",
      "SubstanceName": "PHENDIMETRAZINE TARTRATE",
      "StrengthNumber": "35",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
      "DEASchedule": "CIII",
      "Status": "Active",
      "LastUpdate": "2024-12-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100915",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phendimetrazine tartrate is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. Phendimetrazine tartrate is indicated for use as monotherapy only.",
      "Description": "Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2S,3S)-3,4-Dimethyl-2-phenylmorpholine L-(+)- tartrate (1:1). The structural formula is. Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene. Each white tablet, for oral administration, contains 35 mg of phendimetrazine tartrate. In addition, the following inactive ingredients are present: Colloidal Silicon Dioxide, Lactose Monohydrate, Microcrystalline Cellulose 102, Sodium Starch Glycolate and Stearic Acid. The yellow tablet also contains FD&C Yellow # 5 Aluminum Lake (15-17%). The blue tablet also contains FD&C Blue # 1 Aluminum Lake (11-13%)."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"70404-077-16","ProprietaryName":"Prednisolone","NonProprietaryName":"Prednisolone Oral"},{"NDCCode":"70404-077-14","ProprietaryName":"Prednisolone","NonProprietaryName":"Prednisolone Oral"},{"NDCCode":"36800-077-16","ProprietaryName":"Isopropyl Alcohol","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"52959-077-16","ProprietaryName":"Ibuprofen","NonProprietaryName":"Ibuprofen"},{"NDCCode":"68382-077-16","ProprietaryName":"Fenofibric Acid","NonProprietaryName":"Fenofibric Acid"},{"NDCCode":"69804-077-16","ProprietaryName":"Sore Relief","NonProprietaryName":"Lidocaine Hcl"},{"NDCCode":"83022-077-16","ProprietaryName":"White Tea Tinted Moisturizer","NonProprietaryName":"White Tea Tinted Moisturizer Broad Spectrum Spf 30 Sunscreen"},{"NDCCode":"14222-8010-1","ProprietaryName":"Recharge Protect Blur","NonProprietaryName":"Titanium Dioxide, Zinc Oxide"},{"NDCCode":"42291-077-15","ProprietaryName":"Clobetasol Propionate","NonProprietaryName":"Clobetasol Propionate"},{"NDCCode":"42291-077-30","ProprietaryName":"Clobetasol Propionate","NonProprietaryName":"Clobetasol Propionate"},{"NDCCode":"42291-077-45","ProprietaryName":"Clobetasol Propionate","NonProprietaryName":"Clobetasol Propionate"},{"NDCCode":"42291-077-60","ProprietaryName":"Clobetasol Propionate","NonProprietaryName":"Clobetasol Propionate"},{"NDCCode":"42851-077-56","ProprietaryName":"Vitascrub Invigorating Foaming Scrub","NonProprietaryName":"Salicylic Acid"},{"NDCCode":"42851-077-98","ProprietaryName":"Vitascrub Invigorating Foaming Scrub","NonProprietaryName":"Salicylic Acid"},{"NDCCode":"55910-077-32","ProprietaryName":"Heartburn And Gas Antacid Chews","NonProprietaryName":"Calcium Carbonate"},{"NDCCode":"69423-077-73","ProprietaryName":"Secret Capri Island Retreat Clear","NonProprietaryName":"Aluminum Zirconium Octachlorohydrex Gly"},{"NDCCode":"71209-077-01","ProprietaryName":"Olanzapine","NonProprietaryName":"Olanzapine"},{"NDCCode":"71209-077-05","ProprietaryName":"Olanzapine","NonProprietaryName":"Olanzapine"},{"NDCCode":"71209-077-10","ProprietaryName":"Olanzapine","NonProprietaryName":"Olanzapine"},{"NDCCode":"71209-077-11","ProprietaryName":"Olanzapine","NonProprietaryName":"Olanzapine"},{"NDCCode":"76420-077-01","ProprietaryName":"Dexamethasone Sodium Phosphate","NonProprietaryName":"Dexamethasone Sodium Phosphate"},{"NDCCode":"87063-077-05","ProprietaryName":"Triamcinolone Acetonide","NonProprietaryName":"Triamcinolone Acetonide"},{"NDCCode":"70404-006-01","ProprietaryName":"Oxybutynin Chloride","NonProprietaryName":"Oxybutynin Chloride"},{"NDCCode":"70404-006-03","ProprietaryName":"Oxybutynin Chloride","NonProprietaryName":"Oxybutynin Chloride"},{"NDCCode":"70404-006-05","ProprietaryName":"Oxybutynin Chloride","NonProprietaryName":"Oxybutynin Chloride"},{"NDCCode":"0096-0688-04","ProprietaryName":"Solbar Zinc Spf38","NonProprietaryName":"Solbar Zinc Spf38"},{"NDCCode":"10544-077-06","ProprietaryName":"Phenazopyridine Hcl","NonProprietaryName":"Phenazopyridine Hcl"},{"NDCCode":"10544-077-09","ProprietaryName":"Phenazopyridine Hcl","NonProprietaryName":"Phenazopyridine Hcl"},{"NDCCode":"10702-077-01","ProprietaryName":"Phendimetrazine Tartrate","NonProprietaryName":"Phendimetrazine Tartrate"},{"NDCCode":"10702-077-03","ProprietaryName":"Phendimetrazine Tartrate","NonProprietaryName":"Phendimetrazine Tartrate"}]}
                    

<NDCList><NDC><NDCCode>70404-077-16</NDCCode><ProprietaryName>Prednisolone</ProprietaryName><NonProprietaryName>Prednisolone Oral</NonProprietaryName></NDC><NDC><NDCCode>70404-077-14</NDCCode><ProprietaryName>Prednisolone</ProprietaryName><NonProprietaryName>Prednisolone Oral</NonProprietaryName></NDC><NDC><NDCCode>36800-077-16</NDCCode><ProprietaryName>Isopropyl Alcohol</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>52959-077-16</NDCCode><ProprietaryName>Ibuprofen</ProprietaryName><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>68382-077-16</NDCCode><ProprietaryName>Fenofibric Acid</ProprietaryName><NonProprietaryName>Fenofibric Acid</NonProprietaryName></NDC><NDC><NDCCode>69804-077-16</NDCCode><ProprietaryName>Sore Relief</ProprietaryName><NonProprietaryName>Lidocaine Hcl</NonProprietaryName></NDC><NDC><NDCCode>83022-077-16</NDCCode><ProprietaryName>White Tea Tinted Moisturizer</ProprietaryName><NonProprietaryName>White Tea Tinted Moisturizer Broad Spectrum Spf 30 Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>14222-8010-1</NDCCode><ProprietaryName>Recharge Protect Blur</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>42291-077-15</NDCCode><ProprietaryName>Clobetasol Propionate</ProprietaryName><NonProprietaryName>Clobetasol Propionate</NonProprietaryName></NDC><NDC><NDCCode>42291-077-30</NDCCode><ProprietaryName>Clobetasol Propionate</ProprietaryName><NonProprietaryName>Clobetasol Propionate</NonProprietaryName></NDC><NDC><NDCCode>42291-077-45</NDCCode><ProprietaryName>Clobetasol Propionate</ProprietaryName><NonProprietaryName>Clobetasol Propionate</NonProprietaryName></NDC><NDC><NDCCode>42291-077-60</NDCCode><ProprietaryName>Clobetasol Propionate</ProprietaryName><NonProprietaryName>Clobetasol Propionate</NonProprietaryName></NDC><NDC><NDCCode>42851-077-56</NDCCode><ProprietaryName>Vitascrub Invigorating Foaming Scrub</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>42851-077-98</NDCCode><ProprietaryName>Vitascrub Invigorating Foaming Scrub</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>55910-077-32</NDCCode><ProprietaryName>Heartburn And Gas Antacid Chews</ProprietaryName><NonProprietaryName>Calcium Carbonate</NonProprietaryName></NDC><NDC><NDCCode>69423-077-73</NDCCode><ProprietaryName>Secret Capri Island Retreat Clear</ProprietaryName><NonProprietaryName>Aluminum Zirconium Octachlorohydrex Gly</NonProprietaryName></NDC><NDC><NDCCode>71209-077-01</NDCCode><ProprietaryName>Olanzapine</ProprietaryName><NonProprietaryName>Olanzapine</NonProprietaryName></NDC><NDC><NDCCode>71209-077-05</NDCCode><ProprietaryName>Olanzapine</ProprietaryName><NonProprietaryName>Olanzapine</NonProprietaryName></NDC><NDC><NDCCode>71209-077-10</NDCCode><ProprietaryName>Olanzapine</ProprietaryName><NonProprietaryName>Olanzapine</NonProprietaryName></NDC><NDC><NDCCode>71209-077-11</NDCCode><ProprietaryName>Olanzapine</ProprietaryName><NonProprietaryName>Olanzapine</NonProprietaryName></NDC><NDC><NDCCode>76420-077-01</NDCCode><ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName><NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName></NDC><NDC><NDCCode>87063-077-05</NDCCode><ProprietaryName>Triamcinolone Acetonide</ProprietaryName><NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName></NDC><NDC><NDCCode>70404-006-01</NDCCode><ProprietaryName>Oxybutynin Chloride</ProprietaryName><NonProprietaryName>Oxybutynin Chloride</NonProprietaryName></NDC><NDC><NDCCode>70404-006-03</NDCCode><ProprietaryName>Oxybutynin Chloride</ProprietaryName><NonProprietaryName>Oxybutynin Chloride</NonProprietaryName></NDC><NDC><NDCCode>70404-006-05</NDCCode><ProprietaryName>Oxybutynin Chloride</ProprietaryName><NonProprietaryName>Oxybutynin Chloride</NonProprietaryName></NDC><NDC><NDCCode>0096-0688-04</NDCCode><ProprietaryName>Solbar Zinc Spf38</ProprietaryName><NonProprietaryName>Solbar Zinc Spf38</NonProprietaryName></NDC><NDC><NDCCode>10544-077-06</NDCCode><ProprietaryName>Phenazopyridine Hcl</ProprietaryName><NonProprietaryName>Phenazopyridine Hcl</NonProprietaryName></NDC><NDC><NDCCode>10544-077-09</NDCCode><ProprietaryName>Phenazopyridine Hcl</ProprietaryName><NonProprietaryName>Phenazopyridine Hcl</NonProprietaryName></NDC><NDC><NDCCode>10702-077-01</NDCCode><ProprietaryName>Phendimetrazine Tartrate</ProprietaryName><NonProprietaryName>Phendimetrazine Tartrate</NonProprietaryName></NDC><NDC><NDCCode>10702-077-03</NDCCode><ProprietaryName>Phendimetrazine Tartrate</ProprietaryName><NonProprietaryName>Phendimetrazine Tartrate</NonProprietaryName></NDC></NDCList>