{
"NDC": [
{
"NDCCode": "72162-2051-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (72162-2051-3) ",
"NDC11Code": "72162-2051-03",
"ProductNDC": "72162-2051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211352",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "3.125; 3.125; 3.125; 3.125",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230614",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.",
"Description": "A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. Inactive Ingredients: compressible sugar, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium saccharin, and pregelatinized starch.Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 5 mg, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive."
},
{
"NDCCode": "72162-2051-1",
"PackageDescription": "100 TABLET in 1 BOTTLE (72162-2051-1) ",
"NDC11Code": "72162-2051-01",
"ProductNDC": "72162-2051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211352",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "3.125; 3.125; 3.125; 3.125",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230614",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.",
"Description": "A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. Inactive Ingredients: compressible sugar, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium saccharin, and pregelatinized starch.Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 5 mg, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive."
},
{
"NDCCode": "72162-2051-6",
"PackageDescription": "60 TABLET in 1 BOTTLE (72162-2051-6) ",
"NDC11Code": "72162-2051-06",
"ProductNDC": "72162-2051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211352",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "3.125; 3.125; 3.125; 3.125",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230614",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.",
"Description": "A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. Inactive Ingredients: compressible sugar, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium saccharin, and pregelatinized starch.Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 5 mg, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive."
},
{
"NDCCode": "72162-2051-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (72162-2051-9) ",
"NDC11Code": "72162-2051-09",
"ProductNDC": "72162-2051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211352",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "3.125; 3.125; 3.125; 3.125",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230614",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.",
"Description": "A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. Inactive Ingredients: compressible sugar, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium saccharin, and pregelatinized starch.Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 5 mg, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive."
},
{
"NDCCode": "36987-2051-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-2051-3)",
"NDC11Code": "36987-2051-03",
"ProductNDC": "36987-2051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillium Notatum",
"NonProprietaryName": "Penicillium Notatum",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-2051-3",
"PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (37662-2051-3) ",
"NDC11Code": "37662-2051-03",
"ProductNDC": "37662-2051",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rhus Venenata",
"NonProprietaryName": "Rhus Venenata",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221206",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "TOXICODENDRON VERNIX LEAFY TWIG",
"StrengthNumber": "12",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-12-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221206",
"SamplePackage": "N"
},
{
"NDCCode": "49817-2051-3",
"PackageDescription": "1 BOTTLE in 1 BOX (49817-2051-3) > 15 mL in 1 BOTTLE",
"NDC11Code": "49817-2051-03",
"ProductNDC": "49817-2051",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lessentiel Natural Glow Foundation 16h Wear With Sunscreen Broad Spectrum Spf 20",
"ProprietaryNameSuffix": "055c Fonce Rose/deep Cool",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190310",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Guerlain",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "17.6",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190310",
"SamplePackage": "N"
},
{
"NDCCode": "53645-2051-3",
"PackageDescription": "23 g in 1 BOTTLE (53645-2051-3) ",
"NDC11Code": "53645-2051-03",
"ProductNDC": "53645-2051",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anagallis Arvensis",
"NonProprietaryName": "Anagallis Arvensis",
"DosageFormName": "GLOBULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "True Botanica, LLC",
"SubstanceName": "ANAGALLIS ARVENSIS",
"StrengthNumber": "30",
"StrengthUnit": "[hp_X]/23g",
"Status": "Deprecated",
"LastUpdate": "2023-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140203",
"SamplePackage": "N"
},
{
"NDCCode": "68071-2051-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68071-2051-3) ",
"NDC11Code": "68071-2051-03",
"ProductNDC": "68071-2051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076765",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180119",
"SamplePackage": "N",
"IndicationAndUsage": "Escitalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years ( 1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2) .",
"Description": "Escitalopram tablets USP are an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate, USP, is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-( p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. Escitalopram oxalate, USP, occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets USP are film-coated, round tablets containing escitalopram oxalate, USP, in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: corn starch, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "68745-2051-3",
"PackageDescription": ".7 mL in 1 PACKET (68745-2051-3)",
"NDC11Code": "68745-2051-03",
"ProductNDC": "68745-2051",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Les Beiges",
"ProprietaryNameSuffix": "Healthy Glow Foundation Broad Spectrum Spf 25 Sunscreen No 21",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160504",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CHANEL PARFUMS BEAUTE",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "60; 56",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-03-23",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "71335-2051-3",
"PackageDescription": "90 TABLET in 1 BOTTLE (71335-2051-3) ",
"NDC11Code": "71335-2051-03",
"ProductNDC": "71335-2051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010829",
"EndMarketingDate": "20260501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040362",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240715",
"EndMarketingDatePackage": "20260501",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone Tablets, USP 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 hyperplasiaHypercalcemia 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 arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic 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 ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosisLoeffler’s syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitisRegional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or, impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone, USP is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone, USP 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 Tablets, USP are available in 5 strengths: 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mg. In addition, each tablet contains the following inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains FD & C yellow # 6, aluminum lake, HT 15-18%."
},
{
"NDCCode": "0409-2051-05",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 BOX (0409-2051-05) / 5 mL in 1 VIAL, MULTI-DOSE (0409-2051-15) ",
"NDC11Code": "00409-2051-05",
"ProductNDC": "0409-2051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketamine Hydrochloride",
"NonProprietaryName": "Ketamine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20041130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074549",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "KETAMINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20041130",
"SamplePackage": "N",
"IndicationAndUsage": "Ketamine Hydrochloride Injection is indicated: 1 as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation., 2 for the induction of anesthesia prior to the administration of other general anesthetic agents., 3 as a supplement to other anesthetic agents.",
"Description": "Ketamine Hydrochloride Injection, USP for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white crystalline powder and has a molecular formula of C13H16ClNO∙HCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride. The chemical structure of ketamine hydrochloride is. It is formulated as a slightly acidic (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection. Each milliliter (mL) of the multiple-dose vials contain either 50 mg ketamine base (equivalent to 57.7 mg ketamine hydrochloride) or 100 mg ketamine base (equivalent to 115.3 mg ketamine hydrochloride) and not more than 0.10 mg/mL benzethonium chloride added as a preservative in water for injection."
},
{
"NDCCode": "0517-2051-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2051-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0517-2051-01) ",
"NDC11Code": "00517-2051-25",
"ProductNDC": "0517-2051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphates",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216274",
"LabelerName": "American Regent, Inc.",
"SubstanceName": "POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC",
"StrengthNumber": "224; 236",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231013",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Phosphates Injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.",
"Description": "Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL, and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
},
{
"NDCCode": "0904-2051-12",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0904-2051-12) / 6 TABLET in 1 BLISTER PACK",
"NDC11Code": "00904-2051-12",
"ProductNDC": "0904-2051",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Driminate",
"NonProprietaryName": "Dimenhydrinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19921201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M009",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "DIMENHYDRINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19921201",
"SamplePackage": "N",
"IndicationAndUsage": "for prevention and treatment of these symptoms associated with motion sickness: 1 nausea, 2 vomiting, 3 dizziness."
},
{
"NDCCode": "0904-2051-59",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0904-2051-59) / 100 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "00904-2051-59",
"ProductNDC": "0904-2051",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Driminate",
"NonProprietaryName": "Dimenhydrinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19921201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M009",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "DIMENHYDRINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19921201",
"SamplePackage": "N",
"IndicationAndUsage": "for prevention and treatment of these symptoms associated with motion sickness: 1 nausea, 2 vomiting, 3 dizziness."
},
{
"NDCCode": "72162-1054-3",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (72162-1054-3) ",
"NDC11Code": "72162-1054-03",
"ProductNDC": "72162-1054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Pamoate",
"NonProprietaryName": "Hydroxyzine Pamoate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087479",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "HYDROXYZINE PAMOATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250512",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol ®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine pamoate is a light yellow, practically odorless powder practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol 4,4’-methylenebis[3-hydroxy-2-naphthoate] (1:1) [10246-75-0] and can be structurally represented as follows:. C 21H 27CIN 2O 2C 23H 16O 6. M.W. 763.27. Each capsule, for oral administration, contains hydroxyzine pamoate equivalent to hydroxyzine hydrochloride 25 mg or 50 mg. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate (potato), and sodium lauryl sulfate. The capsule shell contains the following ingredients: D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, gelatin, and titanium dioxide. The edible imprinting ink contains the following ingredients: black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, propylene glycol, and shellac glaze."
},
{
"NDCCode": "72162-1058-3",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (72162-1058-3) ",
"NDC11Code": "72162-1058-03",
"ProductNDC": "72162-1058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20131217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090776",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240801",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The structural formula is. C18H19NOSHCl M.W. 333.88. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20 mg, 30 mg, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include black iron oxide, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The 20 mg and 30 mg capsules also contain FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "72162-1059-3",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1059-3) ",
"NDC11Code": "72162-1059-03",
"ProductNDC": "72162-1059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070312",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078056",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230508",
"SamplePackage": "N",
"Description": "Alprazolam extended-release tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C17H13ClN4 which corresponds to a molecular weight of 308.76. The structural formula is represented below. Alprazolam, USP is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam extended-release tablet USP, for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam, USP. The inactive ingredients are lactose monohydrate, hypromellose, and magnesium stearate. In addition, the 1 mg tablets also contain D&C yellow #10 aluminum lake. The 2 mg tablets also contain FD&C Yellow #6 aluminum lake, and the 3 mg tablets also contain D&C Yellow #10 aluminum lake, and FD&C Blue #2 aluminum lake. Product meets USP Dissolution Test 2."
},
{
"NDCCode": "72162-1076-3",
"PackageDescription": "360 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1076-3) ",
"NDC11Code": "72162-1076-03",
"ProductNDC": "72162-1076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208864",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240405",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release capsules, USP, are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP, equivalent to 8 mEq and 10 mEq of potassium, respectively. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. Potassium chloride, USP, occurs as a white granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive ingredients: ethylcellulose, gelatin, magnesium stearate, sodium lauryl sulfate, titanium dioxide and edible black ink. The 10 mEq capsules also contain black iron oxide, FD&C blue No.1 and FD&C red No.3."
},
{
"NDCCode": "72162-1077-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (72162-1077-3) ",
"NDC11Code": "72162-1077-03",
"ProductNDC": "72162-1077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040230",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230508",
"SamplePackage": "N",
"IndicationAndUsage": "Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine Hydrochloride Capsules, USP for oral use contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, calcium sulfate, magnesium stearate, gelatin, FD&C Blue No. 1, and FD&C Red No. 3. , 2 Dicyclomine Hydrochloride Tablets, USP for oral use contain 20 mg dicyclomine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: acacia, pregelatinized starch, anhydrous lactose, compressible sugar, dicalcium phosphate, colloidal silicon dioxide, magnesium stearate, stearic acid, and FD & C Blue No.1 Aluminum Lake."
},
{
"NDCCode": "72162-1080-3",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (72162-1080-3) ",
"NDC11Code": "72162-1080-03",
"ProductNDC": "72162-1080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077241",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230508",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "72162-1081-3",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (72162-1081-3) ",
"NDC11Code": "72162-1081-03",
"ProductNDC": "72162-1081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077471",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230508",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve hydromorphone hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia."
},
{
"NDCCode": "72162-1082-3",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (72162-1082-3) ",
"NDC11Code": "72162-1082-03",
"ProductNDC": "72162-1082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077471",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230508",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve hydromorphone hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia."
},
{
"NDCCode": "72162-1089-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (72162-1089-3) ",
"NDC11Code": "72162-1089-03",
"ProductNDC": "72162-1089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209193",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231009",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine Hydrochloride Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1.1), 2 Social Anxiety Disorder (SAD) (1.2).",
"Description": "Venlafaxine Hydrochloride Extended-Release Tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4‑methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino) methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Hydrochloride Extended-Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Hydrochloride Extended-Release Tablets use matrix core and extended-release coating to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The unitary tablet core is composed of the drug and excipients (including the matrix forming components). In an aqueous environment, such as the gastrointestinal tract, water permeates slowly through the coating into the tablet core, causing the hydrophilic matrix polymer to expand and to form a gel layer on the surface of the tablet. This gel acts as a barrier to the drug release, the drug is dissolved and is released by slow diffusion and erosion of the gel. The extended-release coating layer controls the rate at which water permeates into the tablet core, which in turn controls also the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. Tablets contain venlafaxine hydrochloride equivalent to 150 mg or 225 mg venlafaxine. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, methacrylic acid copolymer, colloidal silicon dioxide, magnesium stearate, polyvinyl acetate dispersion, talc, polyethylene glycol, polyvinyl alcohol, povidone, triethyl citrate, macrogol stearyl ether, sodium lauryl sulfate, carnauba wax, titanium dioxide, propylene glycol and FD&C blue #1."
},
{
"NDCCode": "72162-1106-3",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1106-3) ",
"NDC11Code": "72162-1106-03",
"ProductNDC": "72162-1106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trospium Chloride",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Trospium Chloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201291",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TROSPIUM CHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230913",
"SamplePackage": "N",
"IndicationAndUsage": "Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Trospium Chloride Extended-Release Capsules are an extended-release formulation of trospium chloride, a quaternary ammonium compound with the chemical name of Spiro [8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride is C25H30ClNO3 and its molecular weight is 427.97. The structural formula of trospium chloride is represented below. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. The compound’s solubility in water is approximately 1 g/2 mL. Trospium Chloride Extended-Release Capsules contain 60 mg of trospium chloride, a muscarinic antagonist, for oral administration. Each capsule also contains the following inactive ingredients: colloidal silicon dioxide, magnesium aluminum silicate, magnesium stearate, methacrylic acid copolymer dispersion, polyethylene glycol 400, povidone, sodium chloride, stearic acid, talc, FD&C yellow no. 6. The capsule shell contains: black iron oxide, gelatin, potassium hydroxide, propylene glycol, shellac, sodium lauryl sulfate and titanium dioxide."
},
{
"NDCCode": "72162-1124-3",
"PackageDescription": "30 g in 1 BOTTLE, PLASTIC (72162-1124-3) ",
"NDC11Code": "72162-1124-03",
"ProductNDC": "72162-1124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystop",
"NonProprietaryName": "Nystatin",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "19960816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064118",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/g",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241224",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.",
"Description": "Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula. Nystatin Topical Powder USP is for dermatologic use. Nystatin Topical Powder USP contains 100,000 USP nystatin units per gram dispersed in talc."
},
{
"NDCCode": "72162-1125-3",
"PackageDescription": "1 TUBE in 1 CARTON (72162-1125-3) / 30 g in 1 TUBE",
"NDC11Code": "72162-1125-03",
"ProductNDC": "72162-1125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine And Prilocaine",
"NonProprietaryName": "Lidocaine And Prilocaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212482",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LIDOCAINE; PRILOCAINE",
"StrengthNumber": "25; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240111",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine and Prilocaine Cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on. normal intact skin for local analgesia. genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine and Prilocaine Cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS).",
"Description": "Lidocaine and Prilocaine Cream, USP 2.5%/2.5% is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram and 30 gram tubes. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure. Prilocaine is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4, and has the following structure. Each gram of Lidocaine and Prilocaine Cream, USP 2.5%/2.5% contains lidocaine 25 mg, prilocaine 25 mg, PEG-60 hydrogenated castor oil (as emulsifier), carbomer homopolymer Type B (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water to 1 gram. Lidocaine and Prilocaine Cream, USP 2.5%/2.5% contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of Lidocaine and Prilocaine Cream is 1.00."
},
{
"NDCCode": "72162-1126-3",
"PackageDescription": "1 TUBE in 1 CARTON (72162-1126-3) / 30 g in 1 TUBE",
"NDC11Code": "72162-1126-03",
"ProductNDC": "72162-1126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciclopirox",
"NonProprietaryName": "Ciclopirox",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078266",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CICLOPIROX",
"StrengthNumber": "7.7",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240311",
"SamplePackage": "N",
"IndicationAndUsage": "Superficial Dermatophyte Infections. Ciclopirox Gel, 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. Seborrheic Dermatitis. Ciclopirox Gel, 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.",
"Description": "Ciclopirox Gel, 0.77% contains a synthetic antifungal agent, ciclopirox. It is intended for topical dermatologic use only. Each gram of Ciclopirox Gel, 0.77% contains 7.70 mg of ciclopirox in a gel consisting of Purified Water USP, Isopropyl Alcohol USP, Octyldodecanol NF, Dimethicone Copolyol 190, Carbomer 980, Sodium Hydroxide NF, and Docusate Sodium USP. Ciclopirox Gel, 0.77% is a white, slightly fluid gel. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)- pyridinone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is."
},
{
"NDCCode": "72162-1176-3",
"PackageDescription": "60 TABLET in 1 BOTTLE (72162-1176-3) ",
"NDC11Code": "72162-1176-03",
"ProductNDC": "72162-1176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100621",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070221",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230710",
"SamplePackage": "N",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are:. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride is available as 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration."
},
{
"NDCCode": "72162-1198-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72162-1198-3) ",
"NDC11Code": "72162-1198-03",
"ProductNDC": "72162-1198",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Voriconazole",
"NonProprietaryName": "Voriconazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200265",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "VORICONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250513",
"SamplePackage": "N",
"IndicationAndUsage": "Voriconazole tablets are an azole antifungal indicated for the treatment of adults and pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight with: 1 Invasive aspergillosis ( 1.1) , 2 Candidemia in non-neutropenics and other deep tissue Candidainfections ( 1.2) , 3 Esophageal candidiasis ( 1.3) , 4 Serious fungal infections caused by Scedosporium apiospermumand Fusariumspecies including Fusarium solani, in patients intolerant of, or refractory to, other therapy ( 1.4) .",
"Description": "Voriconazole, an azole antifungal agent is available as a film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1 H-1,2,4-triazol-1-yl)-2-butanol with the molecular formula of C 16H 14F 3N 5O and a molecular weight of 349.31. Voriconazole drug substance is a white to off-white powder. Voriconazole tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch and a coating containing hypromellose, lactose monohydrate, titanium dioxide and triacetin."
}
]
}
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<NDCList>
<NDC>
<NDCCode>72162-2051-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (72162-2051-3) </PackageDescription>
<NDC11Code>72162-2051-03</NDC11Code>
<ProductNDC>72162-2051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211352</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>3.125; 3.125; 3.125; 3.125</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.</IndicationAndUsage>
<Description>A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. Inactive Ingredients: compressible sugar, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium saccharin, and pregelatinized starch.Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 5 mg, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>72162-2051-1</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (72162-2051-1) </PackageDescription>
<NDC11Code>72162-2051-01</NDC11Code>
<ProductNDC>72162-2051</ProductNDC>
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<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
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<StartMarketingDate>20221229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211352</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
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<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.</IndicationAndUsage>
<Description>A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. Inactive Ingredients: compressible sugar, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium saccharin, and pregelatinized starch.Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 5 mg, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>72162-2051-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (72162-2051-6) </PackageDescription>
<NDC11Code>72162-2051-06</NDC11Code>
<ProductNDC>72162-2051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211352</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>3.125; 3.125; 3.125; 3.125</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.</IndicationAndUsage>
<Description>A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. Inactive Ingredients: compressible sugar, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium saccharin, and pregelatinized starch.Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 5 mg, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>72162-2051-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (72162-2051-9) </PackageDescription>
<NDC11Code>72162-2051-09</NDC11Code>
<ProductNDC>72162-2051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211352</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>3.125; 3.125; 3.125; 3.125</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.</IndicationAndUsage>
<Description>A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. Inactive Ingredients: compressible sugar, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium saccharin, and pregelatinized starch.Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 5 mg, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>36987-2051-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-2051-3)</PackageDescription>
<NDC11Code>36987-2051-03</NDC11Code>
<ProductNDC>36987-2051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillium Notatum</ProprietaryName>
<NonProprietaryName>Penicillium Notatum</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-2051-3</NDCCode>
<PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (37662-2051-3) </PackageDescription>
<NDC11Code>37662-2051-03</NDC11Code>
<ProductNDC>37662-2051</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rhus Venenata</ProprietaryName>
<NonProprietaryName>Rhus Venenata</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221206</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>TOXICODENDRON VERNIX LEAFY TWIG</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-12-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49817-2051-3</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (49817-2051-3) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>49817-2051-03</NDC11Code>
<ProductNDC>49817-2051</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lessentiel Natural Glow Foundation 16h Wear With Sunscreen Broad Spectrum Spf 20</ProprietaryName>
<ProprietaryNameSuffix>055c Fonce Rose/deep Cool</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190310</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Guerlain</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>17.6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53645-2051-3</NDCCode>
<PackageDescription>23 g in 1 BOTTLE (53645-2051-3) </PackageDescription>
<NDC11Code>53645-2051-03</NDC11Code>
<ProductNDC>53645-2051</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anagallis Arvensis</ProprietaryName>
<NonProprietaryName>Anagallis Arvensis</NonProprietaryName>
<DosageFormName>GLOBULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>True Botanica, LLC</LabelerName>
<SubstanceName>ANAGALLIS ARVENSIS</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_X]/23g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68071-2051-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68071-2051-3) </PackageDescription>
<NDC11Code>68071-2051-03</NDC11Code>
<ProductNDC>68071-2051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076765</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Escitalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years ( 1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2) .</IndicationAndUsage>
<Description>Escitalopram tablets USP are an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate, USP, is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-( p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. Escitalopram oxalate, USP, occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets USP are film-coated, round tablets containing escitalopram oxalate, USP, in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: corn starch, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68745-2051-3</NDCCode>
<PackageDescription>.7 mL in 1 PACKET (68745-2051-3)</PackageDescription>
<NDC11Code>68745-2051-03</NDC11Code>
<ProductNDC>68745-2051</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Les Beiges</ProprietaryName>
<ProprietaryNameSuffix>Healthy Glow Foundation Broad Spectrum Spf 25 Sunscreen No 21</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160504</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CHANEL PARFUMS BEAUTE</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>60; 56</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-03-23</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71335-2051-3</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71335-2051-3) </PackageDescription>
<NDC11Code>71335-2051-03</NDC11Code>
<ProductNDC>71335-2051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010829</StartMarketingDate>
<EndMarketingDate>20260501</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040362</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240715</StartMarketingDatePackage>
<EndMarketingDatePackage>20260501</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone Tablets, USP 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 hyperplasiaHypercalcemia 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 arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic 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 ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosisLoeffler’s syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitisRegional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or, impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone, USP is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone, USP 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 Tablets, USP are available in 5 strengths: 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mg. In addition, each tablet contains the following inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains FD & C yellow # 6, aluminum lake, HT 15-18%.</Description>
</NDC>
<NDC>
<NDCCode>0409-2051-05</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 BOX (0409-2051-05) / 5 mL in 1 VIAL, MULTI-DOSE (0409-2051-15) </PackageDescription>
<NDC11Code>00409-2051-05</NDC11Code>
<ProductNDC>0409-2051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketamine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ketamine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20041130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074549</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>KETAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20041130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ketamine Hydrochloride Injection is indicated: 1 as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation., 2 for the induction of anesthesia prior to the administration of other general anesthetic agents., 3 as a supplement to other anesthetic agents.</IndicationAndUsage>
<Description>Ketamine Hydrochloride Injection, USP for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white crystalline powder and has a molecular formula of C13H16ClNO∙HCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride. The chemical structure of ketamine hydrochloride is. It is formulated as a slightly acidic (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection. Each milliliter (mL) of the multiple-dose vials contain either 50 mg ketamine base (equivalent to 57.7 mg ketamine hydrochloride) or 100 mg ketamine base (equivalent to 115.3 mg ketamine hydrochloride) and not more than 0.10 mg/mL benzethonium chloride added as a preservative in water for injection.</Description>
</NDC>
<NDC>
<NDCCode>0517-2051-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2051-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0517-2051-01) </PackageDescription>
<NDC11Code>00517-2051-25</NDC11Code>
<ProductNDC>0517-2051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216274</ApplicationNumber>
<LabelerName>American Regent, Inc.</LabelerName>
<SubstanceName>POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC</SubstanceName>
<StrengthNumber>224; 236</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Phosphates Injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.</IndicationAndUsage>
<Description>Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL, and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route.</Description>
</NDC>
<NDC>
<NDCCode>0904-2051-12</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (0904-2051-12) / 6 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-2051-12</NDC11Code>
<ProductNDC>0904-2051</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Driminate</ProprietaryName>
<NonProprietaryName>Dimenhydrinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19921201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M009</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>DIMENHYDRINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19921201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for prevention and treatment of these symptoms associated with motion sickness: 1 nausea, 2 vomiting, 3 dizziness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0904-2051-59</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0904-2051-59) / 100 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00904-2051-59</NDC11Code>
<ProductNDC>0904-2051</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Driminate</ProprietaryName>
<NonProprietaryName>Dimenhydrinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19921201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M009</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>DIMENHYDRINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19921201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for prevention and treatment of these symptoms associated with motion sickness: 1 nausea, 2 vomiting, 3 dizziness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72162-1054-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (72162-1054-3) </PackageDescription>
<NDC11Code>72162-1054-03</NDC11Code>
<ProductNDC>72162-1054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Pamoate</ProprietaryName>
<NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087479</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>HYDROXYZINE PAMOATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol ®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine pamoate is a light yellow, practically odorless powder practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol 4,4’-methylenebis[3-hydroxy-2-naphthoate] (1:1) [10246-75-0] and can be structurally represented as follows:. C 21H 27CIN 2O 2C 23H 16O 6. M.W. 763.27. Each capsule, for oral administration, contains hydroxyzine pamoate equivalent to hydroxyzine hydrochloride 25 mg or 50 mg. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate (potato), and sodium lauryl sulfate. The capsule shell contains the following ingredients: D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, gelatin, and titanium dioxide. The edible imprinting ink contains the following ingredients: black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, propylene glycol, and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>72162-1058-3</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (72162-1058-3) </PackageDescription>
<NDC11Code>72162-1058-03</NDC11Code>
<ProductNDC>72162-1058</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090776</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The structural formula is. C18H19NOSHCl M.W. 333.88. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20 mg, 30 mg, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include black iron oxide, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The 20 mg and 30 mg capsules also contain FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>72162-1059-3</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1059-3) </PackageDescription>
<NDC11Code>72162-1059-03</NDC11Code>
<ProductNDC>72162-1059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070312</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078056</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Alprazolam extended-release tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C17H13ClN4 which corresponds to a molecular weight of 308.76. The structural formula is represented below. Alprazolam, USP is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam extended-release tablet USP, for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam, USP. The inactive ingredients are lactose monohydrate, hypromellose, and magnesium stearate. In addition, the 1 mg tablets also contain D&C yellow #10 aluminum lake. The 2 mg tablets also contain FD&C Yellow #6 aluminum lake, and the 3 mg tablets also contain D&C Yellow #10 aluminum lake, and FD&C Blue #2 aluminum lake. Product meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>72162-1076-3</NDCCode>
<PackageDescription>360 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1076-3) </PackageDescription>
<NDC11Code>72162-1076-03</NDC11Code>
<ProductNDC>72162-1076</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208864</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
<Description>Potassium chloride extended-release capsules, USP, are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP, equivalent to 8 mEq and 10 mEq of potassium, respectively. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. Potassium chloride, USP, occurs as a white granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive ingredients: ethylcellulose, gelatin, magnesium stearate, sodium lauryl sulfate, titanium dioxide and edible black ink. The 10 mEq capsules also contain black iron oxide, FD&C blue No.1 and FD&C red No.3.</Description>
</NDC>
<NDC>
<NDCCode>72162-1077-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (72162-1077-3) </PackageDescription>
<NDC11Code>72162-1077-03</NDC11Code>
<ProductNDC>72162-1077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040230</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine Hydrochloride Capsules, USP for oral use contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, calcium sulfate, magnesium stearate, gelatin, FD&C Blue No. 1, and FD&C Red No. 3. , 2 Dicyclomine Hydrochloride Tablets, USP for oral use contain 20 mg dicyclomine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: acacia, pregelatinized starch, anhydrous lactose, compressible sugar, dicalcium phosphate, colloidal silicon dioxide, magnesium stearate, stearic acid, and FD & C Blue No.1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>72162-1080-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (72162-1080-3) </PackageDescription>
<NDC11Code>72162-1080-03</NDC11Code>
<ProductNDC>72162-1080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077241</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>72162-1081-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (72162-1081-3) </PackageDescription>
<NDC11Code>72162-1081-03</NDC11Code>
<ProductNDC>72162-1081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077471</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve hydromorphone hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72162-1082-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (72162-1082-3) </PackageDescription>
<NDC11Code>72162-1082-03</NDC11Code>
<ProductNDC>72162-1082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077471</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve hydromorphone hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72162-1089-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (72162-1089-3) </PackageDescription>
<NDC11Code>72162-1089-03</NDC11Code>
<ProductNDC>72162-1089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209193</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine Hydrochloride Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1.1), 2 Social Anxiety Disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Venlafaxine Hydrochloride Extended-Release Tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4‑methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino) methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Hydrochloride Extended-Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Hydrochloride Extended-Release Tablets use matrix core and extended-release coating to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The unitary tablet core is composed of the drug and excipients (including the matrix forming components). In an aqueous environment, such as the gastrointestinal tract, water permeates slowly through the coating into the tablet core, causing the hydrophilic matrix polymer to expand and to form a gel layer on the surface of the tablet. This gel acts as a barrier to the drug release, the drug is dissolved and is released by slow diffusion and erosion of the gel. The extended-release coating layer controls the rate at which water permeates into the tablet core, which in turn controls also the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. Tablets contain venlafaxine hydrochloride equivalent to 150 mg or 225 mg venlafaxine. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, methacrylic acid copolymer, colloidal silicon dioxide, magnesium stearate, polyvinyl acetate dispersion, talc, polyethylene glycol, polyvinyl alcohol, povidone, triethyl citrate, macrogol stearyl ether, sodium lauryl sulfate, carnauba wax, titanium dioxide, propylene glycol and FD&C blue #1.</Description>
</NDC>
<NDC>
<NDCCode>72162-1106-3</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1106-3) </PackageDescription>
<NDC11Code>72162-1106-03</NDC11Code>
<ProductNDC>72162-1106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trospium Chloride</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Trospium Chloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201291</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>TROSPIUM CHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Trospium Chloride Extended-Release Capsules are an extended-release formulation of trospium chloride, a quaternary ammonium compound with the chemical name of Spiro [8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride is C25H30ClNO3 and its molecular weight is 427.97. The structural formula of trospium chloride is represented below. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. The compound’s solubility in water is approximately 1 g/2 mL. Trospium Chloride Extended-Release Capsules contain 60 mg of trospium chloride, a muscarinic antagonist, for oral administration. Each capsule also contains the following inactive ingredients: colloidal silicon dioxide, magnesium aluminum silicate, magnesium stearate, methacrylic acid copolymer dispersion, polyethylene glycol 400, povidone, sodium chloride, stearic acid, talc, FD&C yellow no. 6. The capsule shell contains: black iron oxide, gelatin, potassium hydroxide, propylene glycol, shellac, sodium lauryl sulfate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>72162-1124-3</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PLASTIC (72162-1124-3) </PackageDescription>
<NDC11Code>72162-1124-03</NDC11Code>
<ProductNDC>72162-1124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystop</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19960816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064118</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.</IndicationAndUsage>
<Description>Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula. Nystatin Topical Powder USP is for dermatologic use. Nystatin Topical Powder USP contains 100,000 USP nystatin units per gram dispersed in talc.</Description>
</NDC>
<NDC>
<NDCCode>72162-1125-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72162-1125-3) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>72162-1125-03</NDC11Code>
<ProductNDC>72162-1125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine And Prilocaine</ProprietaryName>
<NonProprietaryName>Lidocaine And Prilocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212482</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LIDOCAINE; PRILOCAINE</SubstanceName>
<StrengthNumber>25; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine and Prilocaine Cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on. normal intact skin for local analgesia. genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine and Prilocaine Cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS).</IndicationAndUsage>
<Description>Lidocaine and Prilocaine Cream, USP 2.5%/2.5% is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram and 30 gram tubes. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure. Prilocaine is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4, and has the following structure. Each gram of Lidocaine and Prilocaine Cream, USP 2.5%/2.5% contains lidocaine 25 mg, prilocaine 25 mg, PEG-60 hydrogenated castor oil (as emulsifier), carbomer homopolymer Type B (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water to 1 gram. Lidocaine and Prilocaine Cream, USP 2.5%/2.5% contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of Lidocaine and Prilocaine Cream is 1.00.</Description>
</NDC>
<NDC>
<NDCCode>72162-1126-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72162-1126-3) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>72162-1126-03</NDC11Code>
<ProductNDC>72162-1126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciclopirox</ProprietaryName>
<NonProprietaryName>Ciclopirox</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078266</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CICLOPIROX</SubstanceName>
<StrengthNumber>7.7</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Superficial Dermatophyte Infections. Ciclopirox Gel, 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. Seborrheic Dermatitis. Ciclopirox Gel, 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.</IndicationAndUsage>
<Description>Ciclopirox Gel, 0.77% contains a synthetic antifungal agent, ciclopirox. It is intended for topical dermatologic use only. Each gram of Ciclopirox Gel, 0.77% contains 7.70 mg of ciclopirox in a gel consisting of Purified Water USP, Isopropyl Alcohol USP, Octyldodecanol NF, Dimethicone Copolyol 190, Carbomer 980, Sodium Hydroxide NF, and Docusate Sodium USP. Ciclopirox Gel, 0.77% is a white, slightly fluid gel. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)- pyridinone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>72162-1176-3</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (72162-1176-3) </PackageDescription>
<NDC11Code>72162-1176-03</NDC11Code>
<ProductNDC>72162-1176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100621</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070221</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are:. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride is available as 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>72162-1198-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (72162-1198-3) </PackageDescription>
<NDC11Code>72162-1198-03</NDC11Code>
<ProductNDC>72162-1198</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Voriconazole</ProprietaryName>
<NonProprietaryName>Voriconazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200265</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>VORICONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Voriconazole tablets are an azole antifungal indicated for the treatment of adults and pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight with: 1 Invasive aspergillosis ( 1.1) , 2 Candidemia in non-neutropenics and other deep tissue Candidainfections ( 1.2) , 3 Esophageal candidiasis ( 1.3) , 4 Serious fungal infections caused by Scedosporium apiospermumand Fusariumspecies including Fusarium solani, in patients intolerant of, or refractory to, other therapy ( 1.4) .</IndicationAndUsage>
<Description>Voriconazole, an azole antifungal agent is available as a film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1 H-1,2,4-triazol-1-yl)-2-butanol with the molecular formula of C 16H 14F 3N 5O and a molecular weight of 349.31. Voriconazole drug substance is a white to off-white powder. Voriconazole tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch and a coating containing hypromellose, lactose monohydrate, titanium dioxide and triacetin.</Description>
</NDC>
</NDCList>