{
"NDC": [
{
"NDCCode": "70710-1070-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70710-1070-3) ",
"NDC11Code": "70710-1070-03",
"ProductNDC": "70710-1070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil",
"NonProprietaryName": "Vardenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208960",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE TRIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181101",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (1).",
"Description": "Vardenafil tablets, USP are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil hydrochloride trihydrate, USP is white or slightly brown or yellow powder. It is slightly soluble in water, freely soluble in anhydrous ethanol and practically insoluble in heptane. Each tablet contains active ingredient vardenafil 2.5 mg (equivalent to 2.963 mg vardenafil hydrochloride trihydrate) or 5 mg (equivalent to 5.926 mg vardenafil hydrochloride trihydrate) or 10 mg (equivalent to 11.852 mg vardenafil hydrochloride trihydrate) or 20 mg (equivalent to 23.705 mg vardenafil hydrochloride trihydrate) and inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide red (5 mg, 10 mg and 20 mg), iron oxide yellow (5 mg, 10 mg and 20 mg), microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn-zea mays), sodium stearyl fumarate, titanium dioxide."
},
{
"NDCCode": "70710-1070-1",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (70710-1070-1) ",
"NDC11Code": "70710-1070-01",
"ProductNDC": "70710-1070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil",
"NonProprietaryName": "Vardenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208960",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE TRIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181101",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (1).",
"Description": "Vardenafil tablets, USP are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil hydrochloride trihydrate, USP is white or slightly brown or yellow powder. It is slightly soluble in water, freely soluble in anhydrous ethanol and practically insoluble in heptane. Each tablet contains active ingredient vardenafil 2.5 mg (equivalent to 2.963 mg vardenafil hydrochloride trihydrate) or 5 mg (equivalent to 5.926 mg vardenafil hydrochloride trihydrate) or 10 mg (equivalent to 11.852 mg vardenafil hydrochloride trihydrate) or 20 mg (equivalent to 23.705 mg vardenafil hydrochloride trihydrate) and inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide red (5 mg, 10 mg and 20 mg), iron oxide yellow (5 mg, 10 mg and 20 mg), microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn-zea mays), sodium stearyl fumarate, titanium dioxide."
},
{
"NDCCode": "70710-1070-9",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70710-1070-9) ",
"NDC11Code": "70710-1070-09",
"ProductNDC": "70710-1070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil",
"NonProprietaryName": "Vardenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208960",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE TRIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181101",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (1).",
"Description": "Vardenafil tablets, USP are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil hydrochloride trihydrate, USP is white or slightly brown or yellow powder. It is slightly soluble in water, freely soluble in anhydrous ethanol and practically insoluble in heptane. Each tablet contains active ingredient vardenafil 2.5 mg (equivalent to 2.963 mg vardenafil hydrochloride trihydrate) or 5 mg (equivalent to 5.926 mg vardenafil hydrochloride trihydrate) or 10 mg (equivalent to 11.852 mg vardenafil hydrochloride trihydrate) or 20 mg (equivalent to 23.705 mg vardenafil hydrochloride trihydrate) and inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide red (5 mg, 10 mg and 20 mg), iron oxide yellow (5 mg, 10 mg and 20 mg), microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn-zea mays), sodium stearyl fumarate, titanium dioxide."
},
{
"NDCCode": "11822-1070-3",
"PackageDescription": "103 mL in 1 TUBE (11822-1070-3) ",
"NDC11Code": "11822-1070-03",
"ProductNDC": "11822-1070",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rite Aid Anti-itch",
"NonProprietaryName": "Diphenhydramine Hcl 2%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210331",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Rite Aid",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210331",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, and rashes due to poison ivy, oak, and sumac."
},
{
"NDCCode": "36987-1070-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-1070-3)",
"NDC11Code": "36987-1070-03",
"ProductNDC": "36987-1070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hamster Epithelium",
"NonProprietaryName": "Hamster Epithelium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "MESOCRICETUS AURATUS SKIN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],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": "37662-1070-3",
"PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (37662-1070-3) ",
"NDC11Code": "37662-1070-03",
"ProductNDC": "37662-1070",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dysprosium Metallicum",
"NonProprietaryName": "Dysprosium Metallicum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220728",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "DYSPROSIUM",
"StrengthNumber": "12",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220728",
"SamplePackage": "N"
},
{
"NDCCode": "49452-1070-3",
"PackageDescription": "25000 mg in 1 BOTTLE, GLASS (49452-1070-3)",
"NDC11Code": "49452-1070-03",
"ProductNDC": "49452-1070",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Betamethasone",
"DosageFormName": "POWDER",
"StartMarketingDate": "19990201",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Spectrum Laboratory Products, Inc",
"SubstanceName": "BETAMETHASONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "67046-1070-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-1070-3) ",
"NDC11Code": "67046-1070-03",
"ProductNDC": "67046-1070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "Coupler LLC",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241108",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy."
},
{
"NDCCode": "68745-1070-3",
"PackageDescription": ".9 mL in 1 PACKET (68745-1070-3)",
"NDC11Code": "68745-1070-03",
"ProductNDC": "68745-1070",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Perfection Lumiere",
"ProprietaryNameSuffix": "Long-wear Flawless Fluid Sunscreen Makeup Broad Spectrum Spf 15, 10 Beige",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CHANEL PARFUMS BEAUTE",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "31",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2014-08-17"
},
{
"NDCCode": "71335-1070-3",
"PackageDescription": "90 TABLET in 1 BOTTLE (71335-1070-3) ",
"NDC11Code": "71335-1070-03",
"ProductNDC": "71335-1070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207419",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "325; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2022-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190131",
"SamplePackage": "N"
},
{
"NDCCode": "79718-1070-3",
"PackageDescription": "15 mL in 1 BOTTLE (79718-1070-3) ",
"NDC11Code": "79718-1070-03",
"ProductNDC": "79718-1070",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Agaricus Muscarius",
"NonProprietaryName": "Agaricus Muscarius",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20201113",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Warsan Homeopathic",
"SubstanceName": "AMBERGRIS",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201113",
"SamplePackage": "N",
"IndicationAndUsage": "Temporary relief from nervousness."
},
{
"NDCCode": "85512-1070-3",
"PackageDescription": "10 g in 1 BOTTLE (85512-1070-3) ",
"NDC11Code": "85512-1070-03",
"ProductNDC": "85512-1070",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Gonadorelin Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250602",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Qingdao Qinzeyuan Biotechnology Co., Ltd",
"SubstanceName": "GONADORELIN ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "02-JUN-25"
},
{
"NDCCode": "0074-1070-01",
"PackageDescription": "1 KIT in 1 CARTON (0074-1070-01) * 2.4 mL in 1 CARTRIDGE (0074-1069-02) * 2.4 mL in 1 CARTRIDGE (0074-1069-01) ",
"NDC11Code": "00074-1070-01",
"ProductNDC": "0074-1070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skyrizi",
"NonProprietaryName": "Risankizumab-rzaa",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761105",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220616",
"SamplePackage": "N",
"IndicationAndUsage": "SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).",
"Description": "Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7."
},
{
"NDCCode": "0074-1070-02",
"PackageDescription": "1 KIT in 1 CARTON (0074-1070-02) * 2.4 mL in 1 CARTRIDGE (0074-1069-02) * 2.4 mL in 1 CARTRIDGE (0074-1069-01) ",
"NDC11Code": "00074-1070-02",
"ProductNDC": "0074-1070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skyrizi",
"NonProprietaryName": "Risankizumab-rzaa",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761105",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220616",
"SamplePackage": "Y",
"IndicationAndUsage": "SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).",
"Description": "Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7."
},
{
"NDCCode": "0078-1070-68",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0078-1070-68) / 2 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00078-1070-68",
"ProductNDC": "0078-1070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cosentyx",
"NonProprietaryName": "Secukinumab",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150121",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125504",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "SECUKINUMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230511",
"SamplePackage": "N",
"IndicationAndUsage": "COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).",
"Description": "Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8."
},
{
"NDCCode": "0078-1070-96",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0078-1070-96) / 2 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00078-1070-96",
"ProductNDC": "0078-1070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cosentyx",
"NonProprietaryName": "Secukinumab",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150121",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125504",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "SECUKINUMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230511",
"SamplePackage": "Y",
"IndicationAndUsage": "COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).",
"Description": "Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8."
},
{
"NDCCode": "0121-1070-04",
"PackageDescription": "118 mL in 1 BOTTLE (0121-1070-04) ",
"NDC11Code": "00121-1070-04",
"ProductNDC": "0121-1070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Dm",
"NonProprietaryName": "Promethazine Hydrochloride And Dextromethorphan Hydrobromide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040649",
"LabelerName": "PAI Holdings, LLC dba PAI Pharma",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "15; 6.25",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250604",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.",
"Description": "Each 5 mL (one teaspoonful), for oral administration contains: Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7%. Inactive Ingredients: Ascorbic acid, citric acid, D&C yellow #10, FD&C yellow #6, menthol, methylparaben, orange pineapple flavor, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose. Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α, 13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NOHBrH2O, and the following structural formula. Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2SHCI, and the following structural formula."
},
{
"NDCCode": "0121-1070-16",
"PackageDescription": "473 mL in 1 BOTTLE (0121-1070-16) ",
"NDC11Code": "00121-1070-16",
"ProductNDC": "0121-1070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Dm",
"NonProprietaryName": "Promethazine Hydrochloride And Dextromethorphan Hydrobromide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040649",
"LabelerName": "PAI Holdings, LLC dba PAI Pharma",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "15; 6.25",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250604",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.",
"Description": "Each 5 mL (one teaspoonful), for oral administration contains: Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7%. Inactive Ingredients: Ascorbic acid, citric acid, D&C yellow #10, FD&C yellow #6, menthol, methylparaben, orange pineapple flavor, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose. Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α, 13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NOHBrH2O, and the following structural formula. Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2SHCI, and the following structural formula."
},
{
"NDCCode": "48951-1070-2",
"PackageDescription": "1350 PELLET in 1 BOTTLE, GLASS (48951-1070-2) ",
"NDC11Code": "48951-1070-02",
"ProductNDC": "48951-1070",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aquilinum Taraxicum",
"NonProprietaryName": "Aquilinum Taraxicum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "ASPLENIUM SCOLOPENDRIUM TOP; CHELIDONIUM MAJUS; DRYOPTERIS FILIX-MAS ROOT; PTERIDIUM AQUILINUM WHOLE; SALIX ALBA FLOWER; SALIX PURPUREA BARK; SOLIDAGO CANADENSIS FLOWERING TOP; TARAXACUM PALUSTRE ROOT; WILLOW BARK",
"StrengthNumber": "3; 3; 3; 3; 3; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: FOR ORAL USE ONLY."
},
{
"NDCCode": "53225-1070-1",
"PackageDescription": "99 g in 1 TUBE (53225-1070-1) ",
"NDC11Code": "53225-1070-01",
"ProductNDC": "53225-1070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclona Gel",
"NonProprietaryName": "Lidocaine 4.5%, Diclofenac 1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220502",
"EndMarketingDate": "20250301",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Terrain Pharmaceuticals",
"SubstanceName": "DICLOFENAC SODIUM; LIDOCAINE",
"StrengthNumber": ".01; .045",
"StrengthUnit": "g/g; g/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220502",
"EndMarketingDatePackage": "20250301",
"SamplePackage": "N",
"IndicationAndUsage": "Diclona Gel is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.",
"Description": "Diclona Gel (Lidocaine 4.5%, Diclofenac 1%) is comprised of a gel inside of a 3.5oz tube containing 4.5% Lidocaine and 1% Diclofenac Sodium. Inactive ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, SD Alcohol 40-B, Sorbitol, Triethanolamine, Water."
},
{
"NDCCode": "54868-1070-1",
"PackageDescription": "5 mL in 1 BOTTLE, PLASTIC (54868-1070-1)",
"NDC11Code": "54868-1070-01",
"ProductNDC": "54868-1070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neomycin And Polymyxin B Sulfates And Dexamethasone",
"NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone",
"DosageFormName": "SUSPENSION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20071204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062721",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE",
"StrengthNumber": "3.5; 10000; 1",
"StrengthUnit": "mg/mL; [USP'U]/mL; mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-03-23",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the papebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcesens and streptococci, including Streptococcus pneumoniae.",
"Description": "Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is. MW = 392.45. Established name: dexamethasone. Chemical name: pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 17, 21-trihydroxy-16-methyl-, (11β, 16α)-. The other active ingredients are neomycin sulfate and polymyxin B sulfate. The structural formula for neomycin sulfate is. The structural formula for polymyxin B sulfate is. Each mL contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Inactives: hypromellose 2910 0.5%, sodium chloride, polysorbate 20, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water, benzalkonium chloride 0.004% (preservative)."
},
{
"NDCCode": "57955-1070-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-1070-2)",
"NDC11Code": "57955-1070-02",
"ProductNDC": "57955-1070",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Self Abuse",
"NonProprietaryName": "Agaricus Muscarius, Aloe Socotrina, Aurum Metallicum, Carboneum Sulphuratum, Chamomilla, Cimicifuga Racemosa, Ilex Aquifolium, Flos, Lilium Tigrinum, Malus Pumila, Flos, Millefolium, Natrum Carbonicum, Pinus Sylvestris, Flos, Stramonium, Tarentula Hispana",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130807",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "AMANITA MUSCARIA FRUITING BODY; ALOE; GOLD; CARBON DISULFIDE; MATRICARIA RECUTITA; BLACK COHOSH; ILEX AQUIFOLIUM FLOWERING TOP; LILIUM LANCIFOLIUM WHOLE FLOWERING; MALUS DOMESTICA FLOWER; ACHILLEA MILLEFOLIUM; SODIUM CARBONATE; PINUS SYLVESTRIS FLOWERING TOP; DATURA STRAMONIUM; LYCOSA TARANTULA",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses a natural aid for: : 1 internalized anger, 2 self-contempt and blame, 3 dissatisfaction with life, 4 violent thoughts/actions, 5 depression, 6 self-inflicted violence."
},
{
"NDCCode": "70710-1000-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70710-1000-3) ",
"NDC11Code": "70710-1000-03",
"ProductNDC": "70710-1000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208971",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180913",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a calcium-sensing receptor agonist indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).",
"Description": "Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet. Its molecular formula is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol, freely soluble in ethanol and practically insoluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3- (trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Each cinacalcet tablet contains 30 mg or 60 mg or 90 mg of cinacalcet (equivalent to 33.060 mg, 66.120 mg, and 99.180 mg of cinacalcet hydrochloride respectively) and inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (botanical source- maize). Additionally film-coating material contains: FD&C blue #1 aluminum lake (90 mg), FD&C blue #2 aluminum lake (60 mg), iron oxide yellow (60mg and 90 mg), polyvinyl alcohol, polyethylene glycols, talc and titanium dioxide."
},
{
"NDCCode": "70710-1001-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70710-1001-3) ",
"NDC11Code": "70710-1001-03",
"ProductNDC": "70710-1001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208971",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180913",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a calcium-sensing receptor agonist indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).",
"Description": "Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet. Its molecular formula is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol, freely soluble in ethanol and practically insoluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3- (trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Each cinacalcet tablet contains 30 mg or 60 mg or 90 mg of cinacalcet (equivalent to 33.060 mg, 66.120 mg, and 99.180 mg of cinacalcet hydrochloride respectively) and inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (botanical source- maize). Additionally film-coating material contains: FD&C blue #1 aluminum lake (90 mg), FD&C blue #2 aluminum lake (60 mg), iron oxide yellow (60mg and 90 mg), polyvinyl alcohol, polyethylene glycols, talc and titanium dioxide."
},
{
"NDCCode": "70710-1002-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70710-1002-3) ",
"NDC11Code": "70710-1002-03",
"ProductNDC": "70710-1002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208971",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180913",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a calcium-sensing receptor agonist indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).",
"Description": "Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet. Its molecular formula is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol, freely soluble in ethanol and practically insoluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3- (trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Each cinacalcet tablet contains 30 mg or 60 mg or 90 mg of cinacalcet (equivalent to 33.060 mg, 66.120 mg, and 99.180 mg of cinacalcet hydrochloride respectively) and inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (botanical source- maize). Additionally film-coating material contains: FD&C blue #1 aluminum lake (90 mg), FD&C blue #2 aluminum lake (60 mg), iron oxide yellow (60mg and 90 mg), polyvinyl alcohol, polyethylene glycols, talc and titanium dioxide."
},
{
"NDCCode": "70710-1011-3",
"PackageDescription": "30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1011-3) ",
"NDC11Code": "70710-1011-03",
"ProductNDC": "70710-1011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferasirox",
"NonProprietaryName": "Deferasirox",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20210506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208882",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DEFERASIROX",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210506",
"SamplePackage": "N",
"IndicationAndUsage": "Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).",
"Description": "Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow color powder. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4. Each deferasirox tablets for oral suspension contains deferasirox 125 mg or 250 mg or 500 mg and following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearte, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "70710-1012-3",
"PackageDescription": "30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1012-3) ",
"NDC11Code": "70710-1012-03",
"ProductNDC": "70710-1012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferasirox",
"NonProprietaryName": "Deferasirox",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20210506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208882",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DEFERASIROX",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210506",
"SamplePackage": "N",
"IndicationAndUsage": "Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).",
"Description": "Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow color powder. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4. Each deferasirox tablets for oral suspension contains deferasirox 125 mg or 250 mg or 500 mg and following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearte, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "70710-1013-3",
"PackageDescription": "30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1013-3) ",
"NDC11Code": "70710-1013-03",
"ProductNDC": "70710-1013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferasirox",
"NonProprietaryName": "Deferasirox",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20210506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208882",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DEFERASIROX",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210506",
"SamplePackage": "N",
"IndicationAndUsage": "Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).",
"Description": "Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow color powder. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4. Each deferasirox tablets for oral suspension contains deferasirox 125 mg or 250 mg or 500 mg and following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearte, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "70710-1014-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (70710-1014-3) ",
"NDC11Code": "70710-1014-03",
"ProductNDC": "70710-1014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phytonadione",
"NonProprietaryName": "Phytonadione",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210189",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "PHYTONADIONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211101",
"SamplePackage": "Y",
"IndicationAndUsage": "Phytonadione is indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives;, 2 hypoprothrombinemia secondary to antibacterial therapy;, 3 hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis;, 4 Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.",
"Description": "Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, viscous, and nearly odorless liquid. It is soluble in dehydrated alcohol, in benzene, in chloroform, in ether and slightly soluble in alcohol. It has a molecular weight of 450.7. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its molecular formula is C31H46O2 and its structural formula is. Each uncoated phytonadione tablet, USP for oral administration contains 5 mg of phytonadione, USP and contains following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "70710-1021-3",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (70710-1021-3) > 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "70710-1021-03",
"ProductNDC": "70710-1021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albendazole",
"NonProprietaryName": "Albendazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208979",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ALBENDAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anthelmintic [EPC], Cytochrome P450 1A Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200527",
"SamplePackage": "N",
"IndicationAndUsage": "Albendazole tablets are an anthelmintic drug indicated for: 1 Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . (1.1), 2 Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus . (1.2).",
"Description": "Albendazole is an orally administered anthelmintic drug. Chemically, it is methyl 5 - (propylthio)-2-benzimidazolecarbamate. Its molecular formula is C12H15N3O2S. Its molecular weight is 265.34. It has the following chemical structure. Albendazole, USP is a white to faintly yellowish powder. It is freely soluble in anhydrous formic acid, very slightly soluble in ether and in methylene chloride, practically insoluble in alcohol and water. Each film-coated tablet contains albendazole USP, 200 mg and inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone K-30, saccharin sodium, sodium lauryl sulfate, sodium starch glycolate type A (botanical source: potato), talc and titanium dioxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>70710-1070-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70710-1070-3) </PackageDescription>
<NDC11Code>70710-1070-03</NDC11Code>
<ProductNDC>70710-1070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil</ProprietaryName>
<NonProprietaryName>Vardenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208960</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VARDENAFIL HYDROCHLORIDE TRIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (1).</IndicationAndUsage>
<Description>Vardenafil tablets, USP are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil hydrochloride trihydrate, USP is white or slightly brown or yellow powder. It is slightly soluble in water, freely soluble in anhydrous ethanol and practically insoluble in heptane. Each tablet contains active ingredient vardenafil 2.5 mg (equivalent to 2.963 mg vardenafil hydrochloride trihydrate) or 5 mg (equivalent to 5.926 mg vardenafil hydrochloride trihydrate) or 10 mg (equivalent to 11.852 mg vardenafil hydrochloride trihydrate) or 20 mg (equivalent to 23.705 mg vardenafil hydrochloride trihydrate) and inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide red (5 mg, 10 mg and 20 mg), iron oxide yellow (5 mg, 10 mg and 20 mg), microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn-zea mays), sodium stearyl fumarate, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1070-1</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (70710-1070-1) </PackageDescription>
<NDC11Code>70710-1070-01</NDC11Code>
<ProductNDC>70710-1070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil</ProprietaryName>
<NonProprietaryName>Vardenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208960</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VARDENAFIL HYDROCHLORIDE TRIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (1).</IndicationAndUsage>
<Description>Vardenafil tablets, USP are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil hydrochloride trihydrate, USP is white or slightly brown or yellow powder. It is slightly soluble in water, freely soluble in anhydrous ethanol and practically insoluble in heptane. Each tablet contains active ingredient vardenafil 2.5 mg (equivalent to 2.963 mg vardenafil hydrochloride trihydrate) or 5 mg (equivalent to 5.926 mg vardenafil hydrochloride trihydrate) or 10 mg (equivalent to 11.852 mg vardenafil hydrochloride trihydrate) or 20 mg (equivalent to 23.705 mg vardenafil hydrochloride trihydrate) and inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide red (5 mg, 10 mg and 20 mg), iron oxide yellow (5 mg, 10 mg and 20 mg), microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn-zea mays), sodium stearyl fumarate, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1070-9</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (70710-1070-9) </PackageDescription>
<NDC11Code>70710-1070-09</NDC11Code>
<ProductNDC>70710-1070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil</ProprietaryName>
<NonProprietaryName>Vardenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208960</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VARDENAFIL HYDROCHLORIDE TRIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (1).</IndicationAndUsage>
<Description>Vardenafil tablets, USP are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil hydrochloride trihydrate, USP is white or slightly brown or yellow powder. It is slightly soluble in water, freely soluble in anhydrous ethanol and practically insoluble in heptane. Each tablet contains active ingredient vardenafil 2.5 mg (equivalent to 2.963 mg vardenafil hydrochloride trihydrate) or 5 mg (equivalent to 5.926 mg vardenafil hydrochloride trihydrate) or 10 mg (equivalent to 11.852 mg vardenafil hydrochloride trihydrate) or 20 mg (equivalent to 23.705 mg vardenafil hydrochloride trihydrate) and inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide red (5 mg, 10 mg and 20 mg), iron oxide yellow (5 mg, 10 mg and 20 mg), microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn-zea mays), sodium stearyl fumarate, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>11822-1070-3</NDCCode>
<PackageDescription>103 mL in 1 TUBE (11822-1070-3) </PackageDescription>
<NDC11Code>11822-1070-03</NDC11Code>
<ProductNDC>11822-1070</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rite Aid Anti-itch</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl 2%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210331</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Rite Aid</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, and rashes due to poison ivy, oak, and sumac.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36987-1070-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-1070-3)</PackageDescription>
<NDC11Code>36987-1070-03</NDC11Code>
<ProductNDC>36987-1070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hamster Epithelium</ProprietaryName>
<NonProprietaryName>Hamster Epithelium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>MESOCRICETUS AURATUS SKIN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],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>37662-1070-3</NDCCode>
<PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (37662-1070-3) </PackageDescription>
<NDC11Code>37662-1070-03</NDC11Code>
<ProductNDC>37662-1070</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dysprosium Metallicum</ProprietaryName>
<NonProprietaryName>Dysprosium Metallicum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220728</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>DYSPROSIUM</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49452-1070-3</NDCCode>
<PackageDescription>25000 mg in 1 BOTTLE, GLASS (49452-1070-3)</PackageDescription>
<NDC11Code>49452-1070-03</NDC11Code>
<ProductNDC>49452-1070</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Betamethasone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19990201</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Spectrum Laboratory Products, Inc</LabelerName>
<SubstanceName>BETAMETHASONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67046-1070-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (67046-1070-3) </PackageDescription>
<NDC11Code>67046-1070-03</NDC11Code>
<ProductNDC>67046-1070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090624</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68745-1070-3</NDCCode>
<PackageDescription>.9 mL in 1 PACKET (68745-1070-3)</PackageDescription>
<NDC11Code>68745-1070-03</NDC11Code>
<ProductNDC>68745-1070</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Perfection Lumiere</ProprietaryName>
<ProprietaryNameSuffix>Long-wear Flawless Fluid Sunscreen Makeup Broad Spectrum Spf 15, 10 Beige</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CHANEL PARFUMS BEAUTE</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>31</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-08-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>71335-1070-3</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71335-1070-3) </PackageDescription>
<NDC11Code>71335-1070-03</NDC11Code>
<ProductNDC>71335-1070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207419</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>79718-1070-3</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE (79718-1070-3) </PackageDescription>
<NDC11Code>79718-1070-03</NDC11Code>
<ProductNDC>79718-1070</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Agaricus Muscarius</ProprietaryName>
<NonProprietaryName>Agaricus Muscarius</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201113</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Warsan Homeopathic</LabelerName>
<SubstanceName>AMBERGRIS</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporary relief from nervousness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85512-1070-3</NDCCode>
<PackageDescription>10 g in 1 BOTTLE (85512-1070-3) </PackageDescription>
<NDC11Code>85512-1070-03</NDC11Code>
<ProductNDC>85512-1070</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Gonadorelin Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250602</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Qingdao Qinzeyuan Biotechnology Co., Ltd</LabelerName>
<SubstanceName>GONADORELIN ACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-JUN-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0074-1070-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-1070-01) * 2.4 mL in 1 CARTRIDGE (0074-1069-02) * 2.4 mL in 1 CARTRIDGE (0074-1069-01) </PackageDescription>
<NDC11Code>00074-1070-01</NDC11Code>
<ProductNDC>0074-1070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Skyrizi</ProprietaryName>
<NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220616</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761105</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).</IndicationAndUsage>
<Description>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</Description>
</NDC>
<NDC>
<NDCCode>0074-1070-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-1070-02) * 2.4 mL in 1 CARTRIDGE (0074-1069-02) * 2.4 mL in 1 CARTRIDGE (0074-1069-01) </PackageDescription>
<NDC11Code>00074-1070-02</NDC11Code>
<ProductNDC>0074-1070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Skyrizi</ProprietaryName>
<NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220616</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761105</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220616</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).</IndicationAndUsage>
<Description>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</Description>
</NDC>
<NDC>
<NDCCode>0078-1070-68</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (0078-1070-68) / 2 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00078-1070-68</NDC11Code>
<ProductNDC>0078-1070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cosentyx</ProprietaryName>
<NonProprietaryName>Secukinumab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150121</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125504</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>SECUKINUMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).</IndicationAndUsage>
<Description>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.</Description>
</NDC>
<NDC>
<NDCCode>0078-1070-96</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (0078-1070-96) / 2 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00078-1070-96</NDC11Code>
<ProductNDC>0078-1070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cosentyx</ProprietaryName>
<NonProprietaryName>Secukinumab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150121</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125504</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>SECUKINUMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230511</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).</IndicationAndUsage>
<Description>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.</Description>
</NDC>
<NDC>
<NDCCode>0121-1070-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (0121-1070-04) </PackageDescription>
<NDC11Code>00121-1070-04</NDC11Code>
<ProductNDC>0121-1070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Dm</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040649</ApplicationNumber>
<LabelerName>PAI Holdings, LLC dba PAI Pharma</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15; 6.25</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.</IndicationAndUsage>
<Description>Each 5 mL (one teaspoonful), for oral administration contains: Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7%. Inactive Ingredients: Ascorbic acid, citric acid, D&C yellow #10, FD&C yellow #6, menthol, methylparaben, orange pineapple flavor, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose. Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α, 13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NOHBrH2O, and the following structural formula. Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2SHCI, and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0121-1070-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (0121-1070-16) </PackageDescription>
<NDC11Code>00121-1070-16</NDC11Code>
<ProductNDC>0121-1070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Dm</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040649</ApplicationNumber>
<LabelerName>PAI Holdings, LLC dba PAI Pharma</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15; 6.25</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.</IndicationAndUsage>
<Description>Each 5 mL (one teaspoonful), for oral administration contains: Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7%. Inactive Ingredients: Ascorbic acid, citric acid, D&C yellow #10, FD&C yellow #6, menthol, methylparaben, orange pineapple flavor, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose. Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α, 13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NOHBrH2O, and the following structural formula. Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2SHCI, and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>48951-1070-2</NDCCode>
<PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-1070-2) </PackageDescription>
<NDC11Code>48951-1070-02</NDC11Code>
<ProductNDC>48951-1070</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aquilinum Taraxicum</ProprietaryName>
<NonProprietaryName>Aquilinum Taraxicum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>ASPLENIUM SCOLOPENDRIUM TOP; CHELIDONIUM MAJUS; DRYOPTERIS FILIX-MAS ROOT; PTERIDIUM AQUILINUM WHOLE; SALIX ALBA FLOWER; SALIX PURPUREA BARK; SOLIDAGO CANADENSIS FLOWERING TOP; TARAXACUM PALUSTRE ROOT; WILLOW BARK</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 3; 3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: FOR ORAL USE ONLY.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53225-1070-1</NDCCode>
<PackageDescription>99 g in 1 TUBE (53225-1070-1) </PackageDescription>
<NDC11Code>53225-1070-01</NDC11Code>
<ProductNDC>53225-1070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclona Gel</ProprietaryName>
<NonProprietaryName>Lidocaine 4.5%, Diclofenac 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220502</StartMarketingDate>
<EndMarketingDate>20250301</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Terrain Pharmaceuticals</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; LIDOCAINE</SubstanceName>
<StrengthNumber>.01; .045</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220502</StartMarketingDatePackage>
<EndMarketingDatePackage>20250301</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclona Gel is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.</IndicationAndUsage>
<Description>Diclona Gel (Lidocaine 4.5%, Diclofenac 1%) is comprised of a gel inside of a 3.5oz tube containing 4.5% Lidocaine and 1% Diclofenac Sodium. Inactive ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, SD Alcohol 40-B, Sorbitol, Triethanolamine, Water.</Description>
</NDC>
<NDC>
<NDCCode>54868-1070-1</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, PLASTIC (54868-1070-1)</PackageDescription>
<NDC11Code>54868-1070-01</NDC11Code>
<ProductNDC>54868-1070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neomycin And Polymyxin B Sulfates And Dexamethasone</ProprietaryName>
<NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20071204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062721</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE</SubstanceName>
<StrengthNumber>3.5; 10000; 1</StrengthNumber>
<StrengthUnit>mg/mL; [USP'U]/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-23</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the papebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcesens and streptococci, including Streptococcus pneumoniae.</IndicationAndUsage>
<Description>Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is. MW = 392.45. Established name: dexamethasone. Chemical name: pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 17, 21-trihydroxy-16-methyl-, (11β, 16α)-. The other active ingredients are neomycin sulfate and polymyxin B sulfate. The structural formula for neomycin sulfate is. The structural formula for polymyxin B sulfate is. Each mL contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Inactives: hypromellose 2910 0.5%, sodium chloride, polysorbate 20, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water, benzalkonium chloride 0.004% (preservative).</Description>
</NDC>
<NDC>
<NDCCode>57955-1070-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-1070-2)</PackageDescription>
<NDC11Code>57955-1070-02</NDC11Code>
<ProductNDC>57955-1070</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Self Abuse</ProprietaryName>
<NonProprietaryName>Agaricus Muscarius, Aloe Socotrina, Aurum Metallicum, Carboneum Sulphuratum, Chamomilla, Cimicifuga Racemosa, Ilex Aquifolium, Flos, Lilium Tigrinum, Malus Pumila, Flos, Millefolium, Natrum Carbonicum, Pinus Sylvestris, Flos, Stramonium, Tarentula Hispana</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130807</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>AMANITA MUSCARIA FRUITING BODY; ALOE; GOLD; CARBON DISULFIDE; MATRICARIA RECUTITA; BLACK COHOSH; ILEX AQUIFOLIUM FLOWERING TOP; LILIUM LANCIFOLIUM WHOLE FLOWERING; MALUS DOMESTICA FLOWER; ACHILLEA MILLEFOLIUM; SODIUM CARBONATE; PINUS SYLVESTRIS FLOWERING TOP; DATURA STRAMONIUM; LYCOSA TARANTULA</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses a natural aid for: : 1 internalized anger, 2 self-contempt and blame, 3 dissatisfaction with life, 4 violent thoughts/actions, 5 depression, 6 self-inflicted violence.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70710-1000-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70710-1000-3) </PackageDescription>
<NDC11Code>70710-1000-03</NDC11Code>
<ProductNDC>70710-1000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208971</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a calcium-sensing receptor agonist indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).</IndicationAndUsage>
<Description>Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet. Its molecular formula is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol, freely soluble in ethanol and practically insoluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3- (trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Each cinacalcet tablet contains 30 mg or 60 mg or 90 mg of cinacalcet (equivalent to 33.060 mg, 66.120 mg, and 99.180 mg of cinacalcet hydrochloride respectively) and inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (botanical source- maize). Additionally film-coating material contains: FD&C blue #1 aluminum lake (90 mg), FD&C blue #2 aluminum lake (60 mg), iron oxide yellow (60mg and 90 mg), polyvinyl alcohol, polyethylene glycols, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1001-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70710-1001-3) </PackageDescription>
<NDC11Code>70710-1001-03</NDC11Code>
<ProductNDC>70710-1001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208971</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a calcium-sensing receptor agonist indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).</IndicationAndUsage>
<Description>Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet. Its molecular formula is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol, freely soluble in ethanol and practically insoluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3- (trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Each cinacalcet tablet contains 30 mg or 60 mg or 90 mg of cinacalcet (equivalent to 33.060 mg, 66.120 mg, and 99.180 mg of cinacalcet hydrochloride respectively) and inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (botanical source- maize). Additionally film-coating material contains: FD&C blue #1 aluminum lake (90 mg), FD&C blue #2 aluminum lake (60 mg), iron oxide yellow (60mg and 90 mg), polyvinyl alcohol, polyethylene glycols, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1002-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70710-1002-3) </PackageDescription>
<NDC11Code>70710-1002-03</NDC11Code>
<ProductNDC>70710-1002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208971</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a calcium-sensing receptor agonist indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).</IndicationAndUsage>
<Description>Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet. Its molecular formula is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol, freely soluble in ethanol and practically insoluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3- (trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Each cinacalcet tablet contains 30 mg or 60 mg or 90 mg of cinacalcet (equivalent to 33.060 mg, 66.120 mg, and 99.180 mg of cinacalcet hydrochloride respectively) and inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (botanical source- maize). Additionally film-coating material contains: FD&C blue #1 aluminum lake (90 mg), FD&C blue #2 aluminum lake (60 mg), iron oxide yellow (60mg and 90 mg), polyvinyl alcohol, polyethylene glycols, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1011-3</NDCCode>
<PackageDescription>30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1011-3) </PackageDescription>
<NDC11Code>70710-1011-03</NDC11Code>
<ProductNDC>70710-1011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deferasirox</ProprietaryName>
<NonProprietaryName>Deferasirox</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208882</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DEFERASIROX</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).</IndicationAndUsage>
<Description>Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow color powder. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4. Each deferasirox tablets for oral suspension contains deferasirox 125 mg or 250 mg or 500 mg and following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearte, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>70710-1012-3</NDCCode>
<PackageDescription>30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1012-3) </PackageDescription>
<NDC11Code>70710-1012-03</NDC11Code>
<ProductNDC>70710-1012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deferasirox</ProprietaryName>
<NonProprietaryName>Deferasirox</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208882</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DEFERASIROX</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).</IndicationAndUsage>
<Description>Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow color powder. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4. Each deferasirox tablets for oral suspension contains deferasirox 125 mg or 250 mg or 500 mg and following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearte, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>70710-1013-3</NDCCode>
<PackageDescription>30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1013-3) </PackageDescription>
<NDC11Code>70710-1013-03</NDC11Code>
<ProductNDC>70710-1013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deferasirox</ProprietaryName>
<NonProprietaryName>Deferasirox</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208882</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DEFERASIROX</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).</IndicationAndUsage>
<Description>Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow color powder. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4. Each deferasirox tablets for oral suspension contains deferasirox 125 mg or 250 mg or 500 mg and following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearte, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>70710-1014-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70710-1014-3) </PackageDescription>
<NDC11Code>70710-1014-03</NDC11Code>
<ProductNDC>70710-1014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phytonadione</ProprietaryName>
<NonProprietaryName>Phytonadione</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210189</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>PHYTONADIONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Phytonadione is indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives;, 2 hypoprothrombinemia secondary to antibacterial therapy;, 3 hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis;, 4 Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.</IndicationAndUsage>
<Description>Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, viscous, and nearly odorless liquid. It is soluble in dehydrated alcohol, in benzene, in chloroform, in ether and slightly soluble in alcohol. It has a molecular weight of 450.7. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its molecular formula is C31H46O2 and its structural formula is. Each uncoated phytonadione tablet, USP for oral administration contains 5 mg of phytonadione, USP and contains following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>70710-1021-3</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (70710-1021-3) > 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1021-03</NDC11Code>
<ProductNDC>70710-1021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Albendazole</ProprietaryName>
<NonProprietaryName>Albendazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208979</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ALBENDAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anthelmintic [EPC], Cytochrome P450 1A Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Albendazole tablets are an anthelmintic drug indicated for: 1 Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . (1.1), 2 Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus . (1.2).</IndicationAndUsage>
<Description>Albendazole is an orally administered anthelmintic drug. Chemically, it is methyl 5 - (propylthio)-2-benzimidazolecarbamate. Its molecular formula is C12H15N3O2S. Its molecular weight is 265.34. It has the following chemical structure. Albendazole, USP is a white to faintly yellowish powder. It is freely soluble in anhydrous formic acid, very slightly soluble in ether and in methylene chloride, practically insoluble in alcohol and water. Each film-coated tablet contains albendazole USP, 200 mg and inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone K-30, saccharin sodium, sodium lauryl sulfate, sodium starch glycolate type A (botanical source: potato), talc and titanium dioxide.</Description>
</NDC>
</NDCList>