{
"NDC": [
{
"NDCCode": "76420-361-80",
"PackageDescription": "80 g in 1 TUBE (76420-361-80) ",
"NDC11Code": "76420-0361-80",
"ProductNDC": "76420-361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19780214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085691",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250523",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone Acetonide Ointment USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-, (11β,16α)-], with the molecular formula C 24H 31FO 6and molecular weight 434.51. CAS 76-25-5. Triamcinolone Acetonide Ointment USP, 0.025% contains: 0.25 mg of triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil. Triamcinolone Acetonide Ointment USP, 0.1% contains: 1 mg triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil."
},
{
"NDCCode": "76420-361-00",
"PackageDescription": "454 g in 1 JAR (76420-361-00) ",
"NDC11Code": "76420-0361-00",
"ProductNDC": "76420-361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19780214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085691",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250523",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone Acetonide Ointment USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-, (11β,16α)-], with the molecular formula C 24H 31FO 6and molecular weight 434.51. CAS 76-25-5. Triamcinolone Acetonide Ointment USP, 0.025% contains: 0.25 mg of triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil. Triamcinolone Acetonide Ointment USP, 0.1% contains: 1 mg triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil."
},
{
"NDCCode": "76420-361-15",
"PackageDescription": "15 g in 1 TUBE (76420-361-15) ",
"NDC11Code": "76420-0361-15",
"ProductNDC": "76420-361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19780214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085691",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250523",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone Acetonide Ointment USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-, (11β,16α)-], with the molecular formula C 24H 31FO 6and molecular weight 434.51. CAS 76-25-5. Triamcinolone Acetonide Ointment USP, 0.025% contains: 0.25 mg of triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil. Triamcinolone Acetonide Ointment USP, 0.1% contains: 1 mg triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil."
},
{
"NDCCode": "76420-347-80",
"PackageDescription": "1 TUBE in 1 CARTON (76420-347-80) / 80 g in 1 TUBE",
"NDC11Code": "76420-0347-80",
"ProductNDC": "76420-347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209535",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250516",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24H 31FO 6and molecular weight 434.50. CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water."
},
{
"NDCCode": "76420-348-80",
"PackageDescription": "1 TUBE in 1 CARTON (76420-348-80) / 80 g in 1 TUBE",
"NDC11Code": "76420-0348-80",
"ProductNDC": "76420-348",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209535",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250516",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24H 31FO 6and molecular weight 434.50. CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water."
},
{
"NDCCode": "76420-360-80",
"PackageDescription": "80 g in 1 TUBE (76420-360-80) ",
"NDC11Code": "76420-0360-80",
"ProductNDC": "76420-360",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19780214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085691",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250523",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone Acetonide Ointment USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-, (11β,16α)-], with the molecular formula C 24H 31FO 6and molecular weight 434.51. CAS 76-25-5. Triamcinolone Acetonide Ointment USP, 0.025% contains: 0.25 mg of triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil. Triamcinolone Acetonide Ointment USP, 0.1% contains: 1 mg triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil."
},
{
"NDCCode": "76420-573-80",
"PackageDescription": "80 mL in 1 BOTTLE (76420-573-80) ",
"NDC11Code": "76420-0573-80",
"ProductNDC": "76420-573",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061931",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2023-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230617",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat:Amoxicillin for oral suspension are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcusspp., or Haemophilus influenzae. , 2 Infections of the Genitourinary Tract:Amoxicillin for oral suspension are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure:Amoxicillin for oral suspension are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspp. (α- and β-hemolytic isolates only), Staphylococcusspp., or E. coli. , 4 Infections of the Lower Respiratory Tract:Amoxicillin for oral suspension are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcusspp., or H. influenzae. .",
"Description": "Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin, USP molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. For Oral Suspension:Each 5 mL of reconstituted suspension contains 250 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Inactive ingredients for 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum."
},
{
"NDCCode": "21130-361-80",
"PackageDescription": "1 BOTTLE in 1 CARTON (21130-361-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "21130-0361-80",
"ProductNDC": "21130-361",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20241015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079205",
"LabelerName": "BETTER LIVING BRANDS, LLC",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241015",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: 1 headache, 2 toothache, 3 backache, 4 menstrual cramps, 5 the common cold, 6 muscular aches, 7 minor pain of arthritis."
},
{
"NDCCode": "68703-361-80",
"PackageDescription": "180 TABLET in 1 BOTTLE, GLASS (68703-361-80) ",
"NDC11Code": "68703-0361-80",
"ProductNDC": "68703-361",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Moodcalm",
"NonProprietaryName": "Hyoscyamus, Kali Phos, Nat Sulphuricum, Tarentula Hisp",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210111",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Silver Star Brands",
"SubstanceName": "LYCOSA TARANTULA; SODIUM SULFATE; HYOSCYAMUS NIGER LEAF; POTASSIUM PHOSPHATE, DIBASIC",
"StrengthNumber": "6; 6; 6; 6",
"StrengthUnit": "[hp_C]/1801; [hp_X]/1801; [hp_C]/1801; [hp_X]/1801",
"Status": "Active",
"LastUpdate": "2025-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210111",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*: Homeopathic remedy for acute agittion, restlessness, or over excitement."
},
{
"NDCCode": "69711-361-01",
"PackageDescription": "80 mL in 1 TUBE, WITH APPLICATOR (69711-361-01) ",
"NDC11Code": "69711-0361-01",
"ProductNDC": "69711-361",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chorus Supernatural Shield Spf30 Broad Spectrum Sunscreen",
"NonProprietaryName": "Zinc Oxide,titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190624",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Derma Soleil",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
"StrengthNumber": "10; 6",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190624",
"SamplePackage": "N"
},
{
"NDCCode": "74871-080-00",
"PackageDescription": "80 PACKET in 1 PACKET (74871-080-00) > 1 mL in 1 PACKET",
"NDC11Code": "74871-0080-00",
"ProductNDC": "74871-080",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tech361 Hytn Alcohol Wipes 80",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200619",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ITECH 361 LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200619",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizing to decrease bacteria on the skin."
},
{
"NDCCode": "74871-081-00",
"PackageDescription": "80 PACKET in 1 PACKET (74871-081-00) > 1 mL in 1 PACKET",
"NDC11Code": "74871-0081-00",
"ProductNDC": "74871-081",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tech361 Hytn Alcohol Wipes 80",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200723",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ITECH 361 LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200723",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to decrease bacteria on the skin."
},
{
"NDCCode": "74871-082-00",
"PackageDescription": "80 PACKET in 1 PACKET (74871-082-00) > 1 mL in 1 PACKET",
"NDC11Code": "74871-0082-00",
"ProductNDC": "74871-082",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ppe361 Alcohol Wipes 80 With Aloe Vera And Vitamin E",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200925",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ITECH 361 LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200925",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to decrease bacteria on the skin."
},
{
"NDCCode": "76420-470-10",
"PackageDescription": "1 KIT in 1 CARTON (76420-470-10) * 1 VIAL, MULTI-DOSE in 1 CARTON (66521-115-10) > 5 mL in 1 VIAL, MULTI-DOSE * 10 POUCH in 1 BAG > 5 mL in 1 POUCH",
"NDC11Code": "76420-0470-10",
"ProductNDC": "76420-470",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Physicians Ez Use Flu Kit",
"NonProprietaryName": "Influenza A Virus A/christchurch/16/2010 Nib-74 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/victoria/361/2011 Ivr-165 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/hubei-wujiagang/158/2009 Bx-39 Antigen (propiolactone Inactivated) And Isopropyl Alcohol",
"DosageFormName": "KIT",
"RouteName": "INTRAMUSCULAR; TOPICAL",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103837",
"LabelerName": "MedChem Manufacturing Inc. dba Enovachem",
"Status": "Deprecated",
"LastUpdate": "2016-12-09"
},
{
"NDCCode": "76420-471-01",
"PackageDescription": "1 KIT in 1 CARTON (76420-471-01) * .5 mL in 1 SYRINGE, GLASS (66521-115-02) * 5 mL in 1 POUCH (42423-271-01)",
"NDC11Code": "76420-0471-01",
"ProductNDC": "76420-471",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Medical Provider Single Use Ez Flu Shot Kit",
"NonProprietaryName": "Influenza A Virus A/christchurch/16/2010 Nib-74 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/victoria/361/2011 Ivr-165 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/hubei-wujiagang/158/2009 Bx-39 Antigen (propiolactone Inactivated) And Isopropyl Alcohol",
"DosageFormName": "KIT",
"RouteName": "INTRAMUSCULAR; TOPICAL",
"StartMarketingDate": "20130530",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103837",
"LabelerName": "MedChem Manufacturing Inc. dba Enovachem",
"Status": "Deprecated",
"LastUpdate": "2016-12-09"
},
{
"NDCCode": "76420-481-01",
"PackageDescription": "1 KIT in 1 CARTON (76420-481-01) * .5 mL in 1 SYRINGE, GLASS (66521-116-02) * 5 mL in 1 POUCH (53329-820-09)",
"NDC11Code": "76420-0481-01",
"ProductNDC": "76420-481",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Medical Provider Single Use Ez Flu Shot 2013-2014",
"NonProprietaryName": "Influenza A Virus A/christchurch/16/2010 Nib-74 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/victoria/361/2011 Ivr-165 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/hubei-wujiagang/158/2009 Bx-39 Antigen (propiolactone Inactivated) And Isopropyl Alcohol",
"DosageFormName": "KIT",
"RouteName": "INTRAMUSCULAR; TOPICAL",
"StartMarketingDate": "20130915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103837",
"LabelerName": "MedChem Manufacturing Inc. dba Enovachem",
"Status": "Deprecated",
"LastUpdate": "2016-12-09"
},
{
"NDCCode": "76420-482-01",
"PackageDescription": "1 KIT in 1 CARTON (76420-482-01) * .5 mL in 1 VIAL, SINGLE-DOSE * 5 mL in 1 POUCH",
"NDC11Code": "76420-0482-01",
"ProductNDC": "76420-482",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Medical Provider Single Use Ez Flu Shot 2013-2014",
"NonProprietaryName": "Influenza A Virus A/christchurch/16/2010 Nib-74 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/victoria/361/2011 Ivr-165 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/hubei-wujiagang/158/2009 Bx-39 Antigen (propiolactone Inactivated) And Isopropyl Alcohol",
"DosageFormName": "KIT",
"RouteName": "INTRAMUSCULAR; TOPICAL",
"StartMarketingDate": "20130530",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103914",
"LabelerName": "MedChem Manufacturing Inc. dba Enovachem",
"Status": "Deprecated",
"LastUpdate": "2016-12-09"
},
{
"NDCCode": "76420-483-01",
"PackageDescription": "1 KIT in 1 CARTON (76420-483-01) * .5 mL in 1 SYRINGE, GLASS * 5 mL in 1 POUCH",
"NDC11Code": "76420-0483-01",
"ProductNDC": "76420-483",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Medical Provider Single Use Ez Flu Shot 2013-2014",
"NonProprietaryName": "Influenza A Virus A/christchurch/16/2010 Nib-74 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/victoria/361/2011 Ivr-165 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/hubei-wujiagang/158/2009 Bx-39 Antigen (propiolactone Inactivated) And Isopropyl Alcohol",
"DosageFormName": "KIT",
"RouteName": "INTRAMUSCULAR; TOPICAL",
"StartMarketingDate": "20130530",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103914",
"LabelerName": "MedChem Manufacturing Inc. dba Enovachem",
"Status": "Deprecated",
"LastUpdate": "2016-12-09"
},
{
"NDCCode": "76420-491-01",
"PackageDescription": "1 KIT in 1 CARTON (76420-491-01) * .5 mL in 1 SYRINGE, GLASS (66521-117-02) * 5 mL in 1 POUCH (53329-820-09)",
"NDC11Code": "76420-0491-01",
"ProductNDC": "76420-491",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Medical Provider Single Use Ez Flu Shot Fluvirin 2014-2015",
"NonProprietaryName": "Influenza A Virus A/christchurch/16/2010 Nib-74 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/victoria/361/2011 Ivr-165 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/hubei-wujiagang/158/2009 Bx-39 Antigen (propiolactone Inactivated) And Isopropyl Alcohol",
"DosageFormName": "KIT",
"RouteName": "INTRAMUSCULAR; TOPICAL",
"StartMarketingDate": "20130915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103837",
"LabelerName": "Asclemed USA, Inc.",
"Status": "Deprecated",
"LastUpdate": "2017-07-11"
},
{
"NDCCode": "76420-748-05",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (76420-748-05) ",
"NDC11Code": "76420-0748-05",
"ProductNDC": "76420-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin Otic",
"DosageFormName": "SOLUTION",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20220715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216130",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Active",
"LastUpdate": "2024-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240612",
"SamplePackage": "N",
"IndicationAndUsage": "Ofloxacin Otic Solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below. Otitis Externain adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosaand Staphylococcus aureus. Chronic Suppurative Otitis Mediain patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosaand Staphylococcus aureus. Acute Otitis Mediain pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureusand Streptococcus pneumoniae.",
"Description": "Ofloxacin Otic Solution 0.3% is a sterile aqueous anti-infective (antibacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxyquinolone with a benzoxazine ring. The chemical name of ofloxacin is: (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7 H-pyrido [1,2,3- de]-1,4-benzoxazine-6-carboxylic acid. The molecular formula of ofloxacin is C 18H 20FN 3O 4and its molecular weight is 361.38. The structural formula is:. Ofloxacin otic solution contains 0.3% (3 mg/mL) ofloxacin, USP with benzalkonium chloride (0.0025%), sodium chloride (0.9%), and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH 6.5±0.5."
},
{
"NDCCode": "76420-749-10",
"PackageDescription": "10 mL in 1 BOTTLE, DROPPER (76420-749-10) ",
"NDC11Code": "76420-0749-10",
"ProductNDC": "76420-749",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin Otic",
"DosageFormName": "SOLUTION",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20220715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216130",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Active",
"LastUpdate": "2024-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240612",
"SamplePackage": "N",
"IndicationAndUsage": "Ofloxacin Otic Solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below. Otitis Externain adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosaand Staphylococcus aureus. Chronic Suppurative Otitis Mediain patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosaand Staphylococcus aureus. Acute Otitis Mediain pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureusand Streptococcus pneumoniae.",
"Description": "Ofloxacin Otic Solution 0.3% is a sterile aqueous anti-infective (antibacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxyquinolone with a benzoxazine ring. The chemical name of ofloxacin is: (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7 H-pyrido [1,2,3- de]-1,4-benzoxazine-6-carboxylic acid. The molecular formula of ofloxacin is C 18H 20FN 3O 4and its molecular weight is 361.38. The structural formula is:. Ofloxacin otic solution contains 0.3% (3 mg/mL) ofloxacin, USP with benzalkonium chloride (0.0025%), sodium chloride (0.9%), and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH 6.5±0.5."
},
{
"NDCCode": "46708-361-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (46708-361-30) ",
"NDC11Code": "46708-0361-30",
"ProductNDC": "46708-361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190809",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210476",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "145",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190809",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:. · To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1). · For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).",
"Description": "Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.80; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose, sodium lauryl sulfate, simethicone, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and magnesium stearate. In addition, individual tablet contains:. 48 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum, iron oxide yellow and iron oxide red. 145 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin and xanthan gum. The USP Dissolution Test is pending."
},
{
"NDCCode": "46708-361-71",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (46708-361-71) ",
"NDC11Code": "46708-0361-71",
"ProductNDC": "46708-361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190809",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210476",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "145",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190809",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:. · To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1). · For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).",
"Description": "Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.80; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose, sodium lauryl sulfate, simethicone, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and magnesium stearate. In addition, individual tablet contains:. 48 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum, iron oxide yellow and iron oxide red. 145 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin and xanthan gum. The USP Dissolution Test is pending."
},
{
"NDCCode": "46708-361-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (46708-361-90) ",
"NDC11Code": "46708-0361-90",
"ProductNDC": "46708-361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190809",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210476",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "145",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190809",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:. · To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1). · For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).",
"Description": "Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.80; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose, sodium lauryl sulfate, simethicone, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and magnesium stearate. In addition, individual tablet contains:. 48 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum, iron oxide yellow and iron oxide red. 145 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin and xanthan gum. The USP Dissolution Test is pending."
},
{
"NDCCode": "50222-361-02",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (50222-361-02) / 1 mL in 1 SYRINGE, GLASS (50222-361-11) ",
"NDC11Code": "50222-0361-02",
"ProductNDC": "50222-361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spevigo",
"NonProprietaryName": "Spesolimab",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260309",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761244",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "SPESOLIMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260309",
"SamplePackage": "N",
"IndicationAndUsage": "SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.",
"Description": "Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8."
},
{
"NDCCode": "51759-361-03",
"PackageDescription": "3 KIT in 1 CARTON (51759-361-03) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * .4 mL in 1 POUCH",
"NDC11Code": "51759-0361-03",
"ProductNDC": "51759-361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adalimumab-ryvk",
"NonProprietaryName": "Adalimumab-ryvk",
"DosageFormName": "KIT",
"StartMarketingDate": "20250228",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761299",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Adalimumab-ryvk is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. (1.1) , 2 Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. (1.2) , 3 Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. (1.3) , 4 Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS. (1.4) , 5 Crohn’s Disease (CD): Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5) , 6 Ulcerative Colitis (UC): Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Plaque Psoriasis (Ps): Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7) , 8 Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in adult patients (1.8) , 9 Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients (1.9) .",
"Description": "Adalimumab-ryvk is a tumor necrosis factor blocker. Adalimumab-ryvk is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-ryvk is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-ryvk injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled Adalimumab-ryvk autoinjector or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-ryvk is clear and colorless, with a pH of 5.0-5.6. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-ryvk contains adalimumab-ryvk (80 mg), polysorbate 80 (0.80 mg), sodium chloride (0.47 mg), sucrose (69.83 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-ryvk contains adalimumab-ryvk (40 mg), polysorbate 80 (0.40 mg), sodium chloride (0.23 mg), sucrose (34.9 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-ryvk contains adalimumab-ryvk (20 mg), polysorbate 80 (0.20 mg), sodium chloride (0.12 mg), sucrose (17.46 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH."
},
{
"NDCCode": "51759-361-17",
"PackageDescription": "1 KIT in 1 CARTON (51759-361-17) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * .4 mL in 1 POUCH",
"NDC11Code": "51759-0361-17",
"ProductNDC": "51759-361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adalimumab-ryvk",
"NonProprietaryName": "Adalimumab-ryvk",
"DosageFormName": "KIT",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761299",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "Adalimumab-ryvk is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older (1.9).",
"Description": "Adalimumab-ryvk is a tumor necrosis factor blocker. Adalimumab-ryvk is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-ryvk is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-ryvk injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled Adalimumab-ryvk autoinjector or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-ryvk is clear and colorless, with a pH of 5.0-5.6. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-ryvk contains adalimumab-ryvk (80 mg), polysorbate 80 (0.80 mg), sodium chloride (0.47 mg), sucrose (69.83 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-ryvk contains adalimumab-ryvk (40 mg), polysorbate 80 (0.40 mg), sodium chloride (0.23 mg), sucrose (34.9 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-ryvk contains adalimumab-ryvk (20 mg), polysorbate 80 (0.20 mg), sodium chloride (0.12 mg), sucrose (17.46 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH."
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"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
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"IndicationAndUsage": "Valsartan tablets are angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).",
"Description": "Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.52, and its structural formula is. Valsartan, USP is a white to off white hygroscopic powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available for oral administration, containing 40 mg, 80 mg, 160 mg and 320 mg of valsartan USP. The inactive ingredients of the tablets are anhydrous lactose, crospovidone, dental-type silica, ferric oxide red (80 mg only), ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. FDA approved dissolution test specifications differ from USP."
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"Description": "Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.52, and its structural formula is. Valsartan, USP is a white to off white hygroscopic powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available for oral administration, containing 40 mg, 80 mg, 160 mg and 320 mg of valsartan USP. The inactive ingredients of the tablets are anhydrous lactose, crospovidone, dental-type silica, ferric oxide red (80 mg only), ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. FDA approved dissolution test specifications differ from USP."
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{
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"Description": "Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.52, and its structural formula is. Valsartan, USP is a white to off white hygroscopic powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available for oral administration, containing 40 mg, 80 mg, 160 mg and 320 mg of valsartan USP. The inactive ingredients of the tablets are anhydrous lactose, crospovidone, dental-type silica, ferric oxide red (80 mg only), ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. FDA approved dissolution test specifications differ from USP."
}
]
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triamcinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
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<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
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<ProprietaryName>Amoxicillin</ProprietaryName>
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<IndicationAndUsage>Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat:Amoxicillin for oral suspension are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcusspp., or Haemophilus influenzae. , 2 Infections of the Genitourinary Tract:Amoxicillin for oral suspension are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure:Amoxicillin for oral suspension are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspp. (α- and β-hemolytic isolates only), Staphylococcusspp., or E. coli. , 4 Infections of the Lower Respiratory Tract:Amoxicillin for oral suspension are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcusspp., or H. influenzae. .</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin, USP molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. For Oral Suspension:Each 5 mL of reconstituted suspension contains 250 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Inactive ingredients for 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum.</Description>
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<ProprietaryName>Chorus Supernatural Shield Spf30 Broad Spectrum Sunscreen</ProprietaryName>
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<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Derma Soleil</LabelerName>
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<LastUpdate>2021-01-01</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<NDC>
<NDCCode>74871-080-00</NDCCode>
<PackageDescription>80 PACKET in 1 PACKET (74871-080-00) > 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>74871-0080-00</NDC11Code>
<ProductNDC>74871-080</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tech361 Hytn Alcohol Wipes 80</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200619</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ITECH 361 LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizing to decrease bacteria on the skin.</IndicationAndUsage>
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<NDC>
<NDCCode>74871-081-00</NDCCode>
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<NDC11Code>74871-0081-00</NDC11Code>
<ProductNDC>74871-081</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tech361 Hytn Alcohol Wipes 80</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200723</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ITECH 361 LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>74871-082-00</NDCCode>
<PackageDescription>80 PACKET in 1 PACKET (74871-082-00) > 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>74871-0082-00</NDC11Code>
<ProductNDC>74871-082</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ppe361 Alcohol Wipes 80 With Aloe Vera And Vitamin E</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200925</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ITECH 361 LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76420-470-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (76420-470-10) * 1 VIAL, MULTI-DOSE in 1 CARTON (66521-115-10) > 5 mL in 1 VIAL, MULTI-DOSE * 10 POUCH in 1 BAG > 5 mL in 1 POUCH</PackageDescription>
<NDC11Code>76420-0470-10</NDC11Code>
<ProductNDC>76420-470</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Physicians Ez Use Flu Kit</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/christchurch/16/2010 Nib-74 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/victoria/361/2011 Ivr-165 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/hubei-wujiagang/158/2009 Bx-39 Antigen (propiolactone Inactivated) And Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAMUSCULAR; TOPICAL</RouteName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103837</ApplicationNumber>
<LabelerName>MedChem Manufacturing Inc. dba Enovachem</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2016-12-09</LastUpdate>
</NDC>
<NDC>
<NDCCode>76420-471-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (76420-471-01) * .5 mL in 1 SYRINGE, GLASS (66521-115-02) * 5 mL in 1 POUCH (42423-271-01)</PackageDescription>
<NDC11Code>76420-0471-01</NDC11Code>
<ProductNDC>76420-471</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Medical Provider Single Use Ez Flu Shot Kit</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/christchurch/16/2010 Nib-74 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/victoria/361/2011 Ivr-165 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/hubei-wujiagang/158/2009 Bx-39 Antigen (propiolactone Inactivated) And Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAMUSCULAR; TOPICAL</RouteName>
<StartMarketingDate>20130530</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103837</ApplicationNumber>
<LabelerName>MedChem Manufacturing Inc. dba Enovachem</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2016-12-09</LastUpdate>
</NDC>
<NDC>
<NDCCode>76420-481-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (76420-481-01) * .5 mL in 1 SYRINGE, GLASS (66521-116-02) * 5 mL in 1 POUCH (53329-820-09)</PackageDescription>
<NDC11Code>76420-0481-01</NDC11Code>
<ProductNDC>76420-481</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Medical Provider Single Use Ez Flu Shot 2013-2014</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/christchurch/16/2010 Nib-74 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/victoria/361/2011 Ivr-165 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/hubei-wujiagang/158/2009 Bx-39 Antigen (propiolactone Inactivated) And Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAMUSCULAR; TOPICAL</RouteName>
<StartMarketingDate>20130915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103837</ApplicationNumber>
<LabelerName>MedChem Manufacturing Inc. dba Enovachem</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2016-12-09</LastUpdate>
</NDC>
<NDC>
<NDCCode>76420-482-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (76420-482-01) * .5 mL in 1 VIAL, SINGLE-DOSE * 5 mL in 1 POUCH</PackageDescription>
<NDC11Code>76420-0482-01</NDC11Code>
<ProductNDC>76420-482</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Medical Provider Single Use Ez Flu Shot 2013-2014</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/christchurch/16/2010 Nib-74 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/victoria/361/2011 Ivr-165 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/hubei-wujiagang/158/2009 Bx-39 Antigen (propiolactone Inactivated) And Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAMUSCULAR; TOPICAL</RouteName>
<StartMarketingDate>20130530</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103914</ApplicationNumber>
<LabelerName>MedChem Manufacturing Inc. dba Enovachem</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2016-12-09</LastUpdate>
</NDC>
<NDC>
<NDCCode>76420-483-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (76420-483-01) * .5 mL in 1 SYRINGE, GLASS * 5 mL in 1 POUCH</PackageDescription>
<NDC11Code>76420-0483-01</NDC11Code>
<ProductNDC>76420-483</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Medical Provider Single Use Ez Flu Shot 2013-2014</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/christchurch/16/2010 Nib-74 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/victoria/361/2011 Ivr-165 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/hubei-wujiagang/158/2009 Bx-39 Antigen (propiolactone Inactivated) And Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAMUSCULAR; TOPICAL</RouteName>
<StartMarketingDate>20130530</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103914</ApplicationNumber>
<LabelerName>MedChem Manufacturing Inc. dba Enovachem</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2016-12-09</LastUpdate>
</NDC>
<NDC>
<NDCCode>76420-491-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (76420-491-01) * .5 mL in 1 SYRINGE, GLASS (66521-117-02) * 5 mL in 1 POUCH (53329-820-09)</PackageDescription>
<NDC11Code>76420-0491-01</NDC11Code>
<ProductNDC>76420-491</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Medical Provider Single Use Ez Flu Shot Fluvirin 2014-2015</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/christchurch/16/2010 Nib-74 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/victoria/361/2011 Ivr-165 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/hubei-wujiagang/158/2009 Bx-39 Antigen (propiolactone Inactivated) And Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAMUSCULAR; TOPICAL</RouteName>
<StartMarketingDate>20130915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103837</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2017-07-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>76420-748-05</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, DROPPER (76420-748-05) </PackageDescription>
<NDC11Code>76420-0748-05</NDC11Code>
<ProductNDC>76420-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
<NonProprietaryName>Ofloxacin Otic</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20220715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216130</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ofloxacin Otic Solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below. Otitis Externain adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosaand Staphylococcus aureus. Chronic Suppurative Otitis Mediain patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosaand Staphylococcus aureus. Acute Otitis Mediain pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureusand Streptococcus pneumoniae.</IndicationAndUsage>
<Description>Ofloxacin Otic Solution 0.3% is a sterile aqueous anti-infective (antibacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxyquinolone with a benzoxazine ring. The chemical name of ofloxacin is: (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7 H-pyrido [1,2,3- de]-1,4-benzoxazine-6-carboxylic acid. The molecular formula of ofloxacin is C 18H 20FN 3O 4and its molecular weight is 361.38. The structural formula is:. Ofloxacin otic solution contains 0.3% (3 mg/mL) ofloxacin, USP with benzalkonium chloride (0.0025%), sodium chloride (0.9%), and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH 6.5±0.5.</Description>
</NDC>
<NDC>
<NDCCode>76420-749-10</NDCCode>
<PackageDescription>10 mL in 1 BOTTLE, DROPPER (76420-749-10) </PackageDescription>
<NDC11Code>76420-0749-10</NDC11Code>
<ProductNDC>76420-749</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
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<DosageFormName>SOLUTION</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20220715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216130</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ofloxacin Otic Solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below. Otitis Externain adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosaand Staphylococcus aureus. Chronic Suppurative Otitis Mediain patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosaand Staphylococcus aureus. Acute Otitis Mediain pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureusand Streptococcus pneumoniae.</IndicationAndUsage>
<Description>Ofloxacin Otic Solution 0.3% is a sterile aqueous anti-infective (antibacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxyquinolone with a benzoxazine ring. The chemical name of ofloxacin is: (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7 H-pyrido [1,2,3- de]-1,4-benzoxazine-6-carboxylic acid. The molecular formula of ofloxacin is C 18H 20FN 3O 4and its molecular weight is 361.38. The structural formula is:. Ofloxacin otic solution contains 0.3% (3 mg/mL) ofloxacin, USP with benzalkonium chloride (0.0025%), sodium chloride (0.9%), and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH 6.5±0.5.</Description>
</NDC>
<NDC>
<NDCCode>46708-361-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (46708-361-30) </PackageDescription>
<NDC11Code>46708-0361-30</NDC11Code>
<ProductNDC>46708-361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190809</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210476</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>145</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:. · To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1). · For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).</IndicationAndUsage>
<Description>Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.80; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose, sodium lauryl sulfate, simethicone, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and magnesium stearate. In addition, individual tablet contains:. 48 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum, iron oxide yellow and iron oxide red. 145 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin and xanthan gum. The USP Dissolution Test is pending.</Description>
</NDC>
<NDC>
<NDCCode>46708-361-71</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (46708-361-71) </PackageDescription>
<NDC11Code>46708-0361-71</NDC11Code>
<ProductNDC>46708-361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190809</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210476</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>145</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:. · To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1). · For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).</IndicationAndUsage>
<Description>Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.80; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose, sodium lauryl sulfate, simethicone, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and magnesium stearate. In addition, individual tablet contains:. 48 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum, iron oxide yellow and iron oxide red. 145 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin and xanthan gum. The USP Dissolution Test is pending.</Description>
</NDC>
<NDC>
<NDCCode>46708-361-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (46708-361-90) </PackageDescription>
<NDC11Code>46708-0361-90</NDC11Code>
<ProductNDC>46708-361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190809</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210476</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>145</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:. · To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1). · For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).</IndicationAndUsage>
<Description>Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.80; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose, sodium lauryl sulfate, simethicone, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and magnesium stearate. In addition, individual tablet contains:. 48 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum, iron oxide yellow and iron oxide red. 145 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin and xanthan gum. The USP Dissolution Test is pending.</Description>
</NDC>
<NDC>
<NDCCode>50222-361-02</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (50222-361-02) / 1 mL in 1 SYRINGE, GLASS (50222-361-11) </PackageDescription>
<NDC11Code>50222-0361-02</NDC11Code>
<ProductNDC>50222-361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spevigo</ProprietaryName>
<NonProprietaryName>Spesolimab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260309</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761244</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>SPESOLIMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.</IndicationAndUsage>
<Description>Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8.</Description>
</NDC>
<NDC>
<NDCCode>51759-361-03</NDCCode>
<PackageDescription>3 KIT in 1 CARTON (51759-361-03) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * .4 mL in 1 POUCH</PackageDescription>
<NDC11Code>51759-0361-03</NDC11Code>
<ProductNDC>51759-361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adalimumab-ryvk</ProprietaryName>
<NonProprietaryName>Adalimumab-ryvk</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250228</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761299</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adalimumab-ryvk is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. (1.1) , 2 Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. (1.2) , 3 Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. (1.3) , 4 Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS. (1.4) , 5 Crohn’s Disease (CD): Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5) , 6 Ulcerative Colitis (UC): Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Plaque Psoriasis (Ps): Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7) , 8 Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in adult patients (1.8) , 9 Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients (1.9) .</IndicationAndUsage>
<Description>Adalimumab-ryvk is a tumor necrosis factor blocker. Adalimumab-ryvk is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-ryvk is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-ryvk injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled Adalimumab-ryvk autoinjector or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-ryvk is clear and colorless, with a pH of 5.0-5.6. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-ryvk contains adalimumab-ryvk (80 mg), polysorbate 80 (0.80 mg), sodium chloride (0.47 mg), sucrose (69.83 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-ryvk contains adalimumab-ryvk (40 mg), polysorbate 80 (0.40 mg), sodium chloride (0.23 mg), sucrose (34.9 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-ryvk contains adalimumab-ryvk (20 mg), polysorbate 80 (0.20 mg), sodium chloride (0.12 mg), sucrose (17.46 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>51759-361-17</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (51759-361-17) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * .4 mL in 1 POUCH</PackageDescription>
<NDC11Code>51759-0361-17</NDC11Code>
<ProductNDC>51759-361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adalimumab-ryvk</ProprietaryName>
<NonProprietaryName>Adalimumab-ryvk</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761299</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adalimumab-ryvk is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older (1.9).</IndicationAndUsage>
<Description>Adalimumab-ryvk is a tumor necrosis factor blocker. Adalimumab-ryvk is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-ryvk is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-ryvk injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled Adalimumab-ryvk autoinjector or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-ryvk is clear and colorless, with a pH of 5.0-5.6. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-ryvk contains adalimumab-ryvk (80 mg), polysorbate 80 (0.80 mg), sodium chloride (0.47 mg), sucrose (69.83 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-ryvk contains adalimumab-ryvk (40 mg), polysorbate 80 (0.40 mg), sodium chloride (0.23 mg), sucrose (34.9 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-ryvk contains adalimumab-ryvk (20 mg), polysorbate 80 (0.20 mg), sodium chloride (0.12 mg), sucrose (17.46 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>59746-361-03</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (59746-361-03) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59746-0361-03</NDC11Code>
<ProductNDC>59746-361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203536</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablets are angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).</IndicationAndUsage>
<Description>Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.52, and its structural formula is. Valsartan, USP is a white to off white hygroscopic powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available for oral administration, containing 40 mg, 80 mg, 160 mg and 320 mg of valsartan USP. The inactive ingredients of the tablets are anhydrous lactose, crospovidone, dental-type silica, ferric oxide red (80 mg only), ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>59746-361-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (59746-361-05) </PackageDescription>
<NDC11Code>59746-0361-05</NDC11Code>
<ProductNDC>59746-361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203536</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablets are angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).</IndicationAndUsage>
<Description>Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.52, and its structural formula is. Valsartan, USP is a white to off white hygroscopic powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available for oral administration, containing 40 mg, 80 mg, 160 mg and 320 mg of valsartan USP. The inactive ingredients of the tablets are anhydrous lactose, crospovidone, dental-type silica, ferric oxide red (80 mg only), ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>59746-361-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (59746-361-30) </PackageDescription>
<NDC11Code>59746-0361-30</NDC11Code>
<ProductNDC>59746-361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203536</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablets are angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).</IndicationAndUsage>
<Description>Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.52, and its structural formula is. Valsartan, USP is a white to off white hygroscopic powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available for oral administration, containing 40 mg, 80 mg, 160 mg and 320 mg of valsartan USP. The inactive ingredients of the tablets are anhydrous lactose, crospovidone, dental-type silica, ferric oxide red (80 mg only), ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
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