RESTful Lookup — Test-Drive (2007 – 2026)

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  <NDC>
    <NDCCode>72189-468-21</NDCCode>
    <PackageDescription>21 TABLET in 1 BOTTLE (72189-468-21) </PackageDescription>
    <NDC11Code>72189-0468-21</NDC11Code>
    <ProductNDC>72189-468</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone</ProprietaryName>
    <NonProprietaryName>Dexamethasone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230504</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215604</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>DEXAMETHASONE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230504</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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, and serum sickness. Dermatologic Diseases. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and 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, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous. Diagnostic testing of adrenocortical hyperfunction, 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, craniotomy, or head injury. Ophthalmic Diseases. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases. To induce a 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 DisordersAs 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.</IndicationAndUsage>
    <Description>Dexamethasone Tablets, USP for oral administration, are supplied in the following potencies, 1.5 mg, 4 mg and 6 mg. Inactive ingredients are Microcrystalline Cellulose, Lactose Anhydrous, Croscarmellose Sodium, Magnesium Stearate, FD&amp;C Blue #1 Aluminum Lake (4 mg, 6 mg), D&amp;C Red #27 Aluminum Lake (1.5 mg), FD&amp;C Red #40 Aluminum Lake (1.5 mg), D&amp;C Yellow #10 Aluminum Lake (1.5 mg, 4 mg, 6 mg). The molecular weight for dexamethasone is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The empirical formula is C22H29FO5 and the structural formula is. [structure]. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-468-15</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE (72189-468-15) </PackageDescription>
    <NDC11Code>72189-0468-15</NDC11Code>
    <ProductNDC>72189-468</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone</ProprietaryName>
    <NonProprietaryName>Dexamethasone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230504</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215604</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>DEXAMETHASONE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230504</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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, and serum sickness. Dermatologic Diseases. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and 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, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous. Diagnostic testing of adrenocortical hyperfunction, 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, craniotomy, or head injury. Ophthalmic Diseases. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases. To induce a 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 DisordersAs 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.</IndicationAndUsage>
    <Description>Dexamethasone Tablets, USP for oral administration, are supplied in the following potencies, 1.5 mg, 4 mg and 6 mg. Inactive ingredients are Microcrystalline Cellulose, Lactose Anhydrous, Croscarmellose Sodium, Magnesium Stearate, FD&amp;C Blue #1 Aluminum Lake (4 mg, 6 mg), D&amp;C Red #27 Aluminum Lake (1.5 mg), FD&amp;C Red #40 Aluminum Lake (1.5 mg), D&amp;C Yellow #10 Aluminum Lake (1.5 mg, 4 mg, 6 mg). The molecular weight for dexamethasone is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The empirical formula is C22H29FO5 and the structural formula is. [structure]. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>47593-468-21</NDCCode>
    <PackageDescription>208000 mL in 1 DRUM (47593-468-21) </PackageDescription>
    <NDC11Code>47593-0468-21</NDC11Code>
    <ProductNDC>47593-468</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Scrub-stat</ProprietaryName>
    <NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110303</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019258</ApplicationNumber>
    <LabelerName>Ecolab Inc.</LabelerName>
    <SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130604</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care. healthcare personnel handwash: handwash to help reduce bacteria that potentially can cause disease.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63739-468-05</NDCCode>
    <PackageDescription>5 POUCH in 1 BOX (63739-468-05)  &gt; 1 VIAL, MULTI-DOSE in 1 POUCH (63739-468-21)  &gt; 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>63739-0468-05</NDC11Code>
    <ProductNDC>63739-468</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Hydrochloride And Epinephrine</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride Anhydrous And Epinephrine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INFILTRATION</RouteName>
    <StartMarketingDate>20100503</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089644</ApplicationNumber>
    <LabelerName>McKesson Packaging Services Business Unit of McKesson Corporation</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE</SubstanceName>
    <StrengthNumber>10; 10</StrengthNumber>
    <StrengthUnit>mg/mL; ug/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>67046-468-21</NDCCode>
    <PackageDescription>21 TABLET, FILM COATED in 1 BLISTER PACK (67046-468-21)</PackageDescription>
    <NDC11Code>67046-0468-21</NDC11Code>
    <ProductNDC>67046-468</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Montelukast Sodium</ProprietaryName>
    <NonProprietaryName>Montelukast Sodium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170921</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204290</ApplicationNumber>
    <LabelerName>Contract Pharmacy Services-PA</LabelerName>
    <SubstanceName>MONTELUKAST SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Montelukast sodium is a leukotriene receptor antagonist indicated for: 1 Prophylaxis and chronic treatment of asthma in patients 12 months of age and older ( 1.1). , 2 Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older ( 1.2). , 3 Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months of age and older (  1.3).  .</IndicationAndUsage>
    <Description>Montelukast sodium, the active ingredient in Montelukast Sodium Tablets,USP is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium is described chemically as [ R-( E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl) ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt. The molecular formula is C 35H 35ClNNaO 3S, and its molecular weight is 608.18. The structural formula is:. Montelukast sodium is a hygroscopic, optically active, white to off-white powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Each 10-mg Montelukast Sodium Tablet, USP contains 10.4 mg montelukast sodium, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol and microcrystalline cellulose. The film coating consists of: carnauba wax, hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-008-21</NDCCode>
    <PackageDescription>21 TABLET in 1 BOTTLE (72189-008-21) </PackageDescription>
    <NDC11Code>72189-0008-21</NDC11Code>
    <ProductNDC>72189-008</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylpred Dp</ProprietaryName>
    <NonProprietaryName>Methylpred Dp</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190626</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040194</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>METHYLPREDNISOLONE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190626</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methylprednisolone tablets are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoids 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. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Synovitis of osteoarthritis. Acute nonspecific tenosynovitis. Post-traumatic osteoarthritis. Psoriatic arthritis. Epicondylitis. Acute gouty arthritis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. 4. Dermatologic Diseases. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Severe seborrheic dermatitis. Exfoliative dermatitis. Mycosis fungoides. Pemphigus. Severe psoriasis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitis. Drug hypersensitivity reactions. Serum sickness. Contact dermatitis. Bronchial asthma. Atopic dermatitis. 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. Keratitis. Optic neuritis. Allergic conjunctivitis. Chorioretinitis. Iritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosis. Berylliosis. Loeffler’s syndrome not manageable by other means. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous 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. Leukemias and lymphomas in adults. Acute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Methylprednisolone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone is a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1, 4-diene-3, 20-dione,11,17,21-trihydroxy-6-methyl-(6α, 11β)-and the molecular weight is 374.48. The structural formula is represented below. [methylprednisolonechemicalstructure]. Each methylprednisolone tablet for oral administration, contains 4 mg methylprednisolone. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-037-21</NDCCode>
    <PackageDescription>21 TABLET, FILM COATED in 1 BOTTLE (72189-037-21) </PackageDescription>
    <NDC11Code>72189-0037-21</NDC11Code>
    <ProductNDC>72189-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
    <NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201506</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1.1 Adult Patients. Cold Sores (Herpes Labialis): Valacyclovir tablets, USP are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir tablets, USP initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Genital Herpes: Initial Episode: Valacyclovir tablets, USP are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets, USP when initiated more than 72 hours after the onset of signs and symptoms has not been established. Recurrent Episodes: Valacyclovir tablets, USP are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets, USP when initiated more than 24 hours after the onset of signs and symptoms has not been established. Suppressive Therapy: Valacyclovir tablets, USP are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in HIV‑infected adults. The efficacy and safety of valacyclovir tablets, USP for the suppression of genital herpes beyond 1 year in immunocompetent patients and beyond 6 months in HIV‑infected patients have not been established. Reduction of Transmission: Valacyclovir tablets, USP are indicated for the reduction of transmission of genital herpes in immunocompetent adults. The efficacy of valacyclovir tablets, USP for the reduction of transmission of genital herpes beyond 8 months in discordant couples has not been established. The efficacy of valacyclovir tablets, USP for the reduction of transmission of genital herpes in individuals with multiple partners and non‑heterosexual couples has not been established. Safer sex practices should be used with suppressive therapy (see current Centers for Disease Control and Prevention [CDC] Sexually Transmitted Diseases Treatment Guidelines). Herpes Zoster: Valacyclovir tablets, USP are indicated for the treatment of herpes zoster (shingles) in immunocompetent adults. The efficacy of valacyclovir tablets, USP when initiated more than 72 hours after the onset of rash and the efficacy and safety of valacyclovir tablets, USP for treatment of disseminated herpes zoster have not been established. 1.2 Pediatric Patients. Cold Sores (Herpes Labialis): Valacyclovir tablets, USP are indicated for the treatment of cold sores (herpes labialis) in pediatric patients ≥12 years of age. The efficacy of valacyclovir tablets, USP initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Chickenpox: Valacyclovir tablets, USP are indicated for the treatment of chickenpox in immunocompetent pediatric patients 2 to &lt;18 years of age. Based on efficacy data from clinical studies with oral acyclovir, treatment with valacyclovir tablets, USP should be initiated within 24 hours after the onset of rash [see CLINICAL STUDIES (14.4)]. 1.3 Limitations of Use. The efficacy and safety of valacyclovir tablets, USP have not been established in. Immunocompromised patients other than for the suppression of genital herpes in HIV‑infected patients with a CD4+ cell count ≥100 cells/mm3.  Patients &lt;12 years of age with cold sores (herpes labialis).  Patients &lt;2 years of age or ≥18 years of age with chickenpox.  Patients &lt;18 years of age with genital herpes.  Patients &lt;18 years of age with herpes zoster.  Neonates and infants as suppressive therapy following neonatal herpes simplex virus (HSV) infection.</IndicationAndUsage>
    <Description>Valacyclovir hydrochloride,USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride, USP equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&amp;C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. [Structure]. Valacyclovir hydrochloride, USP is a white to off-white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pKas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-051-21</NDCCode>
    <PackageDescription>21 TABLET, FILM COATED in 1 BOTTLE (72189-051-21) </PackageDescription>
    <NDC11Code>72189-0051-21</NDC11Code>
    <ProductNDC>72189-051</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valacyclovir</ProprietaryName>
    <NonProprietaryName>Valacyclovir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200617</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203047</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200617</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1.1 Adult Patients. Cold Sores (Herpes Labialis): Valacyclovir tablets, USP are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir tablets, USP initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Genital Herpes: Initial Episode: Valacyclovir tablets, USP are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets, USP when initiated more than 72 hours after the onset of signs and symptoms has not been established. Recurrent Episodes: Valacyclovir tablets, USP are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets, USP when initiated more than 24 hours after the onset of signs and symptoms has not been established. Suppressive Therapy: Valacyclovir tablets, USP are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in HIV‑infected adults. The efficacy and safety of valacyclovir tablets, USP for the suppression of genital herpes beyond 1 year in immunocompetent patients and beyond 6 months in HIV‑infected patients have not been established. Reduction of Transmission: Valacyclovir tablets, USP are indicated for the reduction of transmission of genital herpes in immunocompetent adults. The efficacy of valacyclovir tablets, USP for the reduction of transmission of genital herpes beyond 8 months in discordant couples has not been established. The efficacy of valacyclovir tablets, USP for the reduction of transmission of genital herpes in individuals with multiple partners and non‑heterosexual couples has not been established. Safer sex practices should be used with suppressive therapy (see current Centers for Disease Control and Prevention [CDC] Sexually Transmitted Diseases Treatment Guidelines). Herpes Zoster: Valacyclovir tablets, USP are indicated for the treatment of herpes zoster (shingles) in immunocompetent adults. The efficacy of valacyclovir tablets, USP when initiated more than 72 hours after the onset of rash and the efficacy and safety of valacyclovir tablets, USP for treatment of disseminated herpes zoster have not been established. 1.2 Pediatric Patients. Cold Sores (Herpes Labialis): Valacyclovir tablets, USP are indicated for the treatment of cold sores (herpes labialis) in pediatric patients ≥12 years of age. The efficacy of valacyclovir tablets, USP initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Chickenpox: Valacyclovir tablets, USP are indicated for the treatment of chickenpox in immunocompetent pediatric patients 2 to &lt;18 years of age. Based on efficacy data from clinical studies with oral acyclovir, treatment with valacyclovir tablets, USP should be initiated within 24 hours after the onset of rash [see CLINICAL STUDIES (14.4)]. 1.3 Limitations of Use. The efficacy and safety of valacyclovir tablets, USP have not been established in. Immunocompromised patients other than for the suppression of genital herpes in HIV‑infected patients with a CD4+ cell count ≥100 cells/mm3.  Patients &lt;12 years of age with cold sores (herpes labialis).  Patients &lt;2 years of age or ≥18 years of age with chickenpox.  Patients &lt;18 years of age with genital herpes.  Patients &lt;18 years of age with herpes zoster.  Neonates and infants as suppressive therapy following neonatal herpes simplex virus (HSV) infection.</IndicationAndUsage>
    <Description>Valacyclovir hydrochloride,USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride, USP equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&amp;C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. [Structure]. Valacyclovir hydrochloride, USP is a white to off-white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pKas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-080-21</NDCCode>
    <PackageDescription>21 TABLET, FILM COATED in 1 BOTTLE (72189-080-21) </PackageDescription>
    <NDC11Code>72189-0080-21</NDC11Code>
    <ProductNDC>72189-080</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200513</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208170</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
    <Description>Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N  HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. [Image]. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&amp;C Yellow #10 Aluminum Lake and FD&amp;C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&amp;C Blue #2/INDIGO Carmine Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-189-21</NDCCode>
    <PackageDescription>21 CAPSULE in 1 BOTTLE (72189-189-21) </PackageDescription>
    <NDC11Code>72189-0189-21</NDC11Code>
    <ProductNDC>72189-189</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207402</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&amp;C Blue 1, D&amp;C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&amp;C Blue 1, D&amp;C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&amp;C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint  SW-0012 White Ink. Composition of imprinting ink [TekPrint  SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below: [structure] The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α-D- galacto-octopyranoside monohydrochloride.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-231-21</NDCCode>
    <PackageDescription>21 TABLET, FILM COATED in 1 BOTTLE (72189-231-21) </PackageDescription>
    <NDC11Code>72189-0231-21</NDC11Code>
    <ProductNDC>72189-231</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090796</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>72189-264-21</NDCCode>
    <PackageDescription>21 TABLET in 1 BOTTLE (72189-264-21) </PackageDescription>
    <NDC11Code>72189-0264-21</NDC11Code>
    <ProductNDC>72189-264</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylprednisolone</ProprietaryName>
    <NonProprietaryName>Methylprednisolone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210913</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204072</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>METHYLPREDNISOLONE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210913</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methylprednisolone tablets are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoids 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. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Synovitis of osteoarthritis. Acute nonspecific tenosynovitis. Post-traumatic osteoarthritis. Psoriatic arthritis. Epicondylitis. Acute gouty arthritis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. 4. Dermatologic Diseases. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Severe seborrheic dermatitis. Exfoliative dermatitis. Mycosis fungoides. Pemphigus. Severe psoriasis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitis. Drug hypersensitivity reactions. Serum sickness. Contact dermatitis. Bronchial asthma. Atopic dermatitis. 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. Keratitis. Optic neuritis. Allergic conjunctivitis. Chorioretinitis. Iritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosis. Berylliosis. Loeffler’s syndrome not manageable by other means. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous 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. Leukemias and lymphomas in adults. Acute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Methylprednisolone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone is a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1, 4-diene-3, 20-dione,11,17,21-trihydroxy-6-methyl-(6α, 11β)-and the molecular weight is 374.48. The structural formula is represented below. [methylprednisolonechemicalstructure]. Each methylprednisolone tablet for oral administration, contains 4 mg methylprednisolone. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-275-21</NDCCode>
    <PackageDescription>21 TABLET in 1 BOTTLE (72189-275-21) </PackageDescription>
    <NDC11Code>72189-0275-21</NDC11Code>
    <ProductNDC>72189-275</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210917</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211495</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210917</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Hypercalcemia associated with cancer Nonsuppurative thyroiditis. 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 Systemic dermatomyositis (polymyositis) 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 antituberculous 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: Leukemias and lymphomas in adults Acute leukemia of childhood. 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis. 12. Nervous System Acute exacerbations of multiple sclerosis. 13. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione,17,21-dihydroxy- and its molecular weight is 358.43. The structural formula is represented below. [Prednisone Structure]. Prednisone tablets are available in 3 strengths:10 mg, 20 mg and 50 mg. Inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Cellulose Powder, Magnesium Stearate, and Croscarmellose Sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-430-21</NDCCode>
    <PackageDescription>21 TABLET in 1 BOTTLE (72189-430-21) </PackageDescription>
    <NDC11Code>72189-0430-21</NDC11Code>
    <ProductNDC>72189-430</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230303</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208412</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230303</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone tablets USP 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>Each tablet for oral administration contains. Prednisone, USP.................................................. 10 mg, 20 mg and 50 mg. Inactive Ingredients. The tablets contain lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize starch), sodium starch glycolate and magnesium stearate. 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 pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. [Structure]. Prednisone is a white to practically 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>
  <NDC>
    <NDCCode>72189-545-21</NDCCode>
    <PackageDescription>21 TABLET, FILM COATED in 1 BOTTLE (72189-545-21) </PackageDescription>
    <NDC11Code>72189-0545-21</NDC11Code>
    <ProductNDC>72189-545</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240409</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208170</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240409</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
    <Description>Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N  HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. [Image]. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&amp;C Yellow #10 Aluminum Lake and FD&amp;C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&amp;C Blue #2/INDIGO Carmine Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-556-21</NDCCode>
    <PackageDescription>21 TABLET in 1 BOTTLE (72189-556-21) </PackageDescription>
    <NDC11Code>72189-0556-21</NDC11Code>
    <ProductNDC>72189-556</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240611</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213794</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240611</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
    <Description>Ibuprofen tablets USP contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white to off-white, crystalline powder with a melting point of 74 to 77°C and is very soluble in alcohol, in methanol, in acetone and in chloroform, slightly soluble in ethyl acetate, practically insoluble in water. The structural formula is represented below: [chemical Structure]. 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, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, povidone, stearic acid, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-572-21</NDCCode>
    <PackageDescription>21 TABLET in 1 BOTTLE (72189-572-21) </PackageDescription>
    <NDC11Code>72189-0572-21</NDC11Code>
    <ProductNDC>72189-572</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone</ProprietaryName>
    <NonProprietaryName>Dexamethasone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240904</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216282</ApplicationNumber>
    <LabelerName>Direct_rx</LabelerName>
    <SubstanceName>DEXAMETHASONE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240904</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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 and serum sickness. Dermatologic Diseases. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer and 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, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia and selected cases of secondary thrombocytopenia. Miscellaneous. Diagnostic testing of adrenocortical hyperfunction, 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, craniotomy or head injury. Ophthalmic Diseases. Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases. To induce a 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.</IndicationAndUsage>
    <Description>Dexamethasone tablets, USP for oral administration, are supplied as 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg. Inactive ingredients are corn starch, lactose monohydrate, magnesium stearate and sucrose. Additionally, each 0.5 mg tablet contains ferric oxide yellow, 0.75 mg tablet contains FD&amp;C blue #1 Aluminum Lake and iron oxide black, 1.5 mg tablet contains FD&amp;C red #40 Aluminum Lake and ferric oxide red, 4 mg tablet contains FD&amp;C blue #1 Aluminum Lake and ferric oxide yellow and 6 mg tablet contains FD&amp;C blue #1 Aluminum Lake. The molecular weight for dexamethasone is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The molecular formula is C22H29FO5 and the structural formula is. [Image]. Dexamethasone USP, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is sparingly soluble in alcohol (96% ethanol), acetone, dioxane and in methanol, very slightly soluble in ether and in chloroform and practically insoluble in water. The Product meets USP Dissolution Test#2.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-589-21</NDCCode>
    <PackageDescription>21 TABLET in 1 BOTTLE (72189-589-21) </PackageDescription>
    <NDC11Code>72189-0589-21</NDC11Code>
    <ProductNDC>72189-589</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241015</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208412</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241015</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone tablets USP 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>Each tablet for oral administration contains. Prednisone, USP.................................................. 10 mg, 20 mg and 50 mg. Inactive Ingredients. The tablets contain lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize starch), sodium starch glycolate and magnesium stearate. 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 pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. [Structure]. Prednisone is a white to practically 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>
  <NDC>
    <NDCCode>72189-593-21</NDCCode>
    <PackageDescription>21 TABLET in 1 BOTTLE (72189-593-21) </PackageDescription>
    <NDC11Code>72189-0593-21</NDC11Code>
    <ProductNDC>72189-593</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209727</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone tablets USP 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 and 5 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize starch), sodium starch glycolate. Prednisone tablets USP contain prednisone 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-diene-3,11,20-trione. The structural formula is represented below. [Structure]. Prednisone is a white to practically 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>
  <NDC>
    <NDCCode>72189-594-21</NDCCode>
    <PackageDescription>21 TABLET in 1 BOTTLE (72189-594-21) </PackageDescription>
    <NDC11Code>72189-0594-21</NDC11Code>
    <ProductNDC>72189-594</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valacyclovir</ProprietaryName>
    <NonProprietaryName>Valacyclovir</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209553</ApplicationNumber>
    <LabelerName>Direct _Rx</LabelerName>
    <SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1.1 Adult Patients. Cold Sores (Herpes Labialis). Valacyclovir tablets are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir tablets initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Genital Herpes. Initial Episode: Valacyclovir tablets are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets when initiated more than 72 hours after the onset of signs and symptoms has not been established. Recurrent Episodes: Valacyclovir tablets are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets when initiated more than 24 hours after the onset of signs and symptoms has not been established. Suppressive Therapy: Valacyclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in HIV-1-infected adults. The efficacy and safety of valacyclovir tablets for the suppression of genital herpes beyond 1 year in immunocompetent patients and beyond 6 months in HIV-1-infected patients have not been established. Reduction of Transmission: Valacyclovir tablets are indicated for the reduction of transmission of genital herpes in immunocompetent adults. The efficacy of valacyclovir tablets for the reduction of transmission of genital herpes beyond 8 months in discordant couples has not been established. The efficacy of valacyclovir tablets for the reduction of transmission of genital herpes in individuals with multiple partners and non-heterosexual couples has not been established. Safer sex practices should be used with suppressive therapy (see current Centers for Disease Control and Prevention [CDC] Sexually Transmitted Diseases Treatment Guidelines). Herpes Zoster. Valacyclovir tablets are indicated for the treatment of herpes zoster (shingles) in immunocompetent adults. The efficacy of valacyclovir tablets when initiated more than 72 hours after the onset of rash and the efficacy and safety of valacyclovir tablets for treatment of disseminated herpes zoster have not been established. 1.2 Pediatric Patients. Cold Sores (Herpes Labialis). Valacyclovir tablets are indicated for the treatment of cold sores (herpes labialis) in pediatric patients aged greater than or equal to 12 years. The efficacy of valacyclovir tablets initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Chickenpox. Valacyclovir tablets are indicated for the treatment of chickenpox in immunocompetent pediatric patients aged 2 to less than 18 years. Based on efficacy data from clinical trials with oral acyclovir, treatment with valacyclovir tablets should be initiated within 24 hours after the onset of rash [see Clinical Studies (14.4)]. 1.3 Limitations of Use. The efficacy and safety of valacyclovir tablets have not been established in. Immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients with a CD4+ cell count greater than or equal to 100 cells/mm3. Patients aged less than 12 years with cold sores (herpes labialis). Patients aged less than 2 years or greater than or equal to 18 years with chickenpox. Patients aged less than 18 years with genital herpes. Patients aged less than 18 years with herpes zoster. Neonates and infants as suppressive therapy following neonatal herpes simplex virus (HSV) infection.</IndicationAndUsage>
    <Description>Valacyclovir Tablets, USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir Tablets, USP are for oral administration. Each tablet contains 556.2 mg or 1.112 grams of valacyclovir hydrochloride equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, FD&amp;C blue #2, hypromellose, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone K90, and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. [Chemical Structure]. Valacyclovir hydrochloride is a white to off-white powder with the molecular formula C13H20N6O4∙HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-643-21</NDCCode>
    <PackageDescription>21 TABLET, FILM COATED in 1 BOTTLE (72189-643-21) </PackageDescription>
    <NDC11Code>72189-0643-21</NDC11Code>
    <ProductNDC>72189-643</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078329</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250930</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
    <Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74° to 77° C and is very slightly soluble in water (&lt;1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. [chem structure]. Ibuprofen tablets, 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, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, magnesium stearate, Opadry II contains hypromellose, polyethylene glycol, sodium citrate, lactose monohydrate and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-646-21</NDCCode>
    <PackageDescription>21 TABLET in 1 CARTON (72189-646-21) </PackageDescription>
    <NDC11Code>72189-0646-21</NDC11Code>
    <ProductNDC>72189-646</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone D/p</ProprietaryName>
    <NonProprietaryName>Prednisone D/p</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA085162</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone tablets, USP 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. 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 contain prednisone 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 pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural formula is represented below. [structural formula for prednisone]. C21H26O5 M.W. 358.44. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of prednisone, USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone tablets, USP 20 mg also contain FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-673-21</NDCCode>
    <PackageDescription>21 TABLET in 1 BLISTER PACK (72189-673-21) </PackageDescription>
    <NDC11Code>72189-0673-21</NDC11Code>
    <ProductNDC>72189-673</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone D/p</ProprietaryName>
    <NonProprietaryName>Prednisone D/p</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260409</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211575</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260409</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone Tablets, USP 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 2.5 mg, 5 mg, 10 mg, 20 mg and 50 mg of prednisone, USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and sodium starch glycolate. Prednisone Tablets, USP contain prednisone 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 pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy-. The structural formula is represented below: [structure]. Molecular Formula: C21H26O5. Molecular Weight: 358.44. Prednisone is a white or almost white crystalline powder. It is slightly soluble in acetone, ethanol, ethylacetate and methanol. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>13537-435-01</NDCCode>
    <PackageDescription>60 g in 1 TUBE (13537-435-01)</PackageDescription>
    <NDC11Code>13537-0435-01</NDC11Code>
    <ProductNDC>13537-435</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cyzone</ProprietaryName>
    <ProprietaryNameSuffix>Sun By Me Face Screen Fps 50 Amplio Espectro</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Octocrylene, Oxybenzone, Octisalate, Titanium Dioxide, And Ensulizole</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120914</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura Corporation LTD.</LabelerName>
    <SubstanceName>OCTINOXATE; OCTOCRYLENE; OXYBENZONE; OCTISALATE; TITANIUM DIOXIDE; ENSULIZOLE</SubstanceName>
    <StrengthNumber>.075; .07; .06; .05; .468; .03</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g; g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Ayuda a prevenir quemaduras solares. Si se usa según las indicaciones con otras medidas de protección (ver Instrucciones), disminuye el riesgo de cancer en la piel y el envejecimiento prematuro causados por el sol.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13537-468-04</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (13537-468-04)  &gt; 12 mL in 1 TUBE (13537-468-03)</PackageDescription>
    <NDC11Code>13537-0468-04</NDC11Code>
    <ProductNDC>13537-468</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Divine Lip Gloss Spf 15</ProprietaryName>
    <ProprietaryNameSuffix>(grape Lumiere) - Magenta</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
    <DosageFormName>LIPSTICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140127</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura Corporation LTD</LabelerName>
    <SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.075; .03</StrengthNumber>
    <StrengthUnit>g/mL; g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>14783-468-04</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (14783-468-04)  &gt; 12 mL in 1 TUBE (14783-468-03)</PackageDescription>
    <NDC11Code>14783-0468-04</NDC11Code>
    <ProductNDC>14783-468</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Divine Lip Gloss Spf 15</ProprietaryName>
    <ProprietaryNameSuffix>(grape Lumiere) - Magenta</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
    <DosageFormName>LIPSTICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140127</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura International LTD</LabelerName>
    <SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.075; .03</StrengthNumber>
    <StrengthUnit>g/mL; g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21695-468-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (21695-468-30)</PackageDescription>
    <NDC11Code>21695-0468-30</NDC11Code>
    <ProductNDC>21695-468</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glyburide</ProprietaryName>
    <NonProprietaryName>Glyburide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020806</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076257</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>GLYBURIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Glyburide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Glyburide tablets USP contain glyburide, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide is a white, crystalline compound. The chemical name for glyburide is 1-[[ρ-[2-(5-chloro-ο-anisamido)- ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is 493.99. It has the following structural formula. Molecular formula: C23H28ClN3O5S. Each tablet, for oral administration, contains 1.25 mg, 2.5 mg or 5 mg of glyburide. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate. In addition, the 2.5 mg contains D&amp;C yellow No. 10 Aluminum Lake and the 5 mg contains FD&amp;C Blue No. 1 Aluminum Lake and D&amp;C Yellow No. 10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-468-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (21695-468-60)</PackageDescription>
    <NDC11Code>21695-0468-60</NDC11Code>
    <ProductNDC>21695-468</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glyburide</ProprietaryName>
    <NonProprietaryName>Glyburide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020806</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076257</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>GLYBURIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Glyburide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Glyburide tablets USP contain glyburide, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide is a white, crystalline compound. The chemical name for glyburide is 1-[[ρ-[2-(5-chloro-ο-anisamido)- ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is 493.99. It has the following structural formula. Molecular formula: C23H28ClN3O5S. Each tablet, for oral administration, contains 1.25 mg, 2.5 mg or 5 mg of glyburide. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate. In addition, the 2.5 mg contains D&amp;C yellow No. 10 Aluminum Lake and the 5 mg contains FD&amp;C Blue No. 1 Aluminum Lake and D&amp;C Yellow No. 10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-468-72</NDCCode>
    <PackageDescription>120 TABLET in 1 BOTTLE (21695-468-72)</PackageDescription>
    <NDC11Code>21695-0468-72</NDC11Code>
    <ProductNDC>21695-468</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glyburide</ProprietaryName>
    <NonProprietaryName>Glyburide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020806</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076257</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>GLYBURIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Glyburide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Glyburide tablets USP contain glyburide, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide is a white, crystalline compound. The chemical name for glyburide is 1-[[ρ-[2-(5-chloro-ο-anisamido)- ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is 493.99. It has the following structural formula. Molecular formula: C23H28ClN3O5S. Each tablet, for oral administration, contains 1.25 mg, 2.5 mg or 5 mg of glyburide. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate. In addition, the 2.5 mg contains D&amp;C yellow No. 10 Aluminum Lake and the 5 mg contains FD&amp;C Blue No. 1 Aluminum Lake and D&amp;C Yellow No. 10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-468-78</NDCCode>
    <PackageDescription>180 TABLET in 1 BOTTLE (21695-468-78)</PackageDescription>
    <NDC11Code>21695-0468-78</NDC11Code>
    <ProductNDC>21695-468</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glyburide</ProprietaryName>
    <NonProprietaryName>Glyburide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020806</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076257</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>GLYBURIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Glyburide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Glyburide tablets USP contain glyburide, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide is a white, crystalline compound. The chemical name for glyburide is 1-[[ρ-[2-(5-chloro-ο-anisamido)- ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is 493.99. It has the following structural formula. Molecular formula: C23H28ClN3O5S. Each tablet, for oral administration, contains 1.25 mg, 2.5 mg or 5 mg of glyburide. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate. In addition, the 2.5 mg contains D&amp;C yellow No. 10 Aluminum Lake and the 5 mg contains FD&amp;C Blue No. 1 Aluminum Lake and D&amp;C Yellow No. 10 Aluminum Lake.</Description>
  </NDC>
</NDCList>