{
"NDC": [
{
"NDCCode": "49502-501-92",
"PackageDescription": "2 CONTAINER in 1 CARTON (49502-501-92) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS",
"NDC11Code": "49502-0501-92",
"ProductNDC": "49502-501",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epipen Jr",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "19871222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019430",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".15",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19871222",
"SamplePackage": "Y",
"IndicationAndUsage": "EpiPen and EpiPen Jr are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. EpiPen and EpiPen Jr are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. EpiPen and EpiPen Jr are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.",
"Description": "EpiPen (epinephrine injection, USP) 0.3 mg and EpiPen Jr (epinephrine injection, USP) 0.15 mg are single-dose auto-injectors and combination products containing drug and device components. Each EpiPen Auto-Injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL in a sterile solution. Each EpiPen Jr Auto-Injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL in a sterile solution. Each 0.3 mL in the EpiPen Auto-Injector contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Each 0.3 mL in the EpiPen Jr Auto-Injector contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4- Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace EpiPen and EpiPen Jr if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of EpiPen or EpiPen Jr with patients and caregivers prior to use [see Patient Counseling Information (17)]."
},
{
"NDCCode": "49502-500-92",
"PackageDescription": "2 CONTAINER in 1 CARTON (49502-500-92) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS",
"NDC11Code": "49502-0500-92",
"ProductNDC": "49502-500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epipen",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "19871222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019430",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19871222",
"SamplePackage": "Y",
"IndicationAndUsage": "EpiPen and EpiPen Jr are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. EpiPen and EpiPen Jr are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. EpiPen and EpiPen Jr are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.",
"Description": "EpiPen (epinephrine injection, USP) 0.3 mg and EpiPen Jr (epinephrine injection, USP) 0.15 mg are single-dose auto-injectors and combination products containing drug and device components. Each EpiPen Auto-Injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL in a sterile solution. Each EpiPen Jr Auto-Injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL in a sterile solution. Each 0.3 mL in the EpiPen Auto-Injector contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Each 0.3 mL in the EpiPen Jr Auto-Injector contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4- Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace EpiPen and EpiPen Jr if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of EpiPen or EpiPen Jr with patients and caregivers prior to use [see Patient Counseling Information (17)]."
},
{
"NDCCode": "71610-501-92",
"PackageDescription": "270 TABLET in 1 BOTTLE (71610-501-92) ",
"NDC11Code": "71610-0501-92",
"ProductNDC": "71610-501",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibu",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075682",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2021-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201208",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.",
"Description": "IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powde rwith a melting point of 74-77° C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. IBU, a nonsteroidal anti-inflammatory drug (NSAID), is availablein 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystallinecellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide."
},
{
"NDCCode": "49502-501-01",
"PackageDescription": "1 CONTAINER in 1 CARTON (49502-501-01) > 1 SYRINGE, GLASS in 1 CONTAINER > .3 mL in 1 SYRINGE, GLASS",
"NDC11Code": "49502-0501-01",
"ProductNDC": "49502-501",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epipen Jr",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "19871222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019430",
"LabelerName": "Mylan Specialty L.P.",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".15",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-01-08"
},
{
"NDCCode": "49502-501-02",
"PackageDescription": "2 CONTAINER in 1 CARTON (49502-501-02) / 1 SYRINGE, GLASS in 1 CONTAINER (49502-501-01) / .3 mL in 1 SYRINGE, GLASS",
"NDC11Code": "49502-0501-02",
"ProductNDC": "49502-501",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epipen Jr",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "19871222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019430",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".15",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19871222",
"SamplePackage": "N",
"IndicationAndUsage": "EpiPen and EpiPen Jr are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. EpiPen and EpiPen Jr are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. EpiPen and EpiPen Jr are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.",
"Description": "EpiPen (epinephrine injection, USP) 0.3 mg and EpiPen Jr (epinephrine injection, USP) 0.15 mg are single-dose auto-injectors and combination products containing drug and device components. Each EpiPen Auto-Injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL in a sterile solution. Each EpiPen Jr Auto-Injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL in a sterile solution. Each 0.3 mL in the EpiPen Auto-Injector contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Each 0.3 mL in the EpiPen Jr Auto-Injector contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4- Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace EpiPen and EpiPen Jr if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of EpiPen or EpiPen Jr with patients and caregivers prior to use [see Patient Counseling Information (17)]."
},
{
"NDCCode": "49502-605-05",
"PackageDescription": "5 POUCH in 1 CARTON (49502-605-05) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL",
"NDC11Code": "49502-0605-05",
"ProductNDC": "49502-605",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perforomist",
"NonProprietaryName": "Formoterol Fumarate Dihydrate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20071001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022007",
"LabelerName": "Mylan Specialty L.P.",
"SubstanceName": "FORMOTEROL FUMARATE",
"StrengthNumber": "20",
"StrengthUnit": "ug/2mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20071001",
"EndMarketingDatePackage": "20230630",
"SamplePackage": "Y",
"IndicationAndUsage": "PERFOROMIST Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).",
"Description": "PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of PERFOROMIST Inhalation Solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is. Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C19H24N2O4)2C4H4O42H2O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. PERFOROMIST Inhalation Solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) connected to a PRONEB® Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. PERFOROMIST Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece."
},
{
"NDCCode": "49502-605-30",
"PackageDescription": "30 POUCH in 1 CARTON (49502-605-30) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL",
"NDC11Code": "49502-0605-30",
"ProductNDC": "49502-605",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perforomist",
"NonProprietaryName": "Formoterol Fumarate Dihydrate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20071001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022007",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "FORMOTEROL FUMARATE",
"StrengthNumber": "20",
"StrengthUnit": "ug/2mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20071001",
"SamplePackage": "N",
"IndicationAndUsage": "PERFOROMIST Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).",
"Description": "PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of PERFOROMIST Inhalation Solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is. Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C19H24N2O4)2C4H4O42H2O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. PERFOROMIST Inhalation Solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) connected to a PRONEB® Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. PERFOROMIST Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece."
},
{
"NDCCode": "49502-605-61",
"PackageDescription": "60 POUCH in 1 CARTON (49502-605-61) / 1 VIAL in 1 POUCH (49502-605-95) / 2 mL in 1 VIAL",
"NDC11Code": "49502-0605-61",
"ProductNDC": "49502-605",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perforomist",
"NonProprietaryName": "Formoterol Fumarate Dihydrate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20071001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022007",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "FORMOTEROL FUMARATE",
"StrengthNumber": "20",
"StrengthUnit": "ug/2mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20071001",
"SamplePackage": "N",
"IndicationAndUsage": "PERFOROMIST Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).",
"Description": "PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of PERFOROMIST Inhalation Solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is. Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C19H24N2O4)2C4H4O42H2O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. PERFOROMIST Inhalation Solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) connected to a PRONEB® Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. PERFOROMIST Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece."
},
{
"NDCCode": "49502-101-02",
"PackageDescription": "2 CONTAINER in 1 CARTON (49502-101-02) / 1 SYRINGE, GLASS in 1 CONTAINER (49502-101-01) / .3 mL in 1 SYRINGE, GLASS",
"NDC11Code": "49502-0101-02",
"ProductNDC": "49502-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrine",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20161215",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019430",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".15",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161215",
"SamplePackage": "N",
"IndicationAndUsage": "Epinephrine injection, USP auto-injectors are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine injection, USP auto-injectors are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. Epinephrine injection, USP auto-injectors are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.",
"Description": "Epinephrine injection, USP auto-injectors, 0.3 mg and 0.15 mg, are single-dose auto-injectors and combination products containing drug and device components. Each epinephrine injection, USP auto-injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL in a sterile solution. Each epinephrine injection, USP auto-injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL in a sterile solution. Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.3 mg contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.15 mg contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4- Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of epinephrine injection, USP auto-injector with patients and caregivers prior to use [see Patient Counseling Information (17)]."
},
{
"NDCCode": "49502-102-02",
"PackageDescription": "2 CONTAINER in 1 CARTON (49502-102-02) / 1 SYRINGE, GLASS in 1 CONTAINER (49502-102-01) / .3 mL in 1 SYRINGE, GLASS",
"NDC11Code": "49502-0102-02",
"ProductNDC": "49502-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrine",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20161215",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019430",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161215",
"SamplePackage": "N",
"IndicationAndUsage": "Epinephrine injection, USP auto-injectors are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine injection, USP auto-injectors are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. Epinephrine injection, USP auto-injectors are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.",
"Description": "Epinephrine injection, USP auto-injectors, 0.3 mg and 0.15 mg, are single-dose auto-injectors and combination products containing drug and device components. Each epinephrine injection, USP auto-injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL in a sterile solution. Each epinephrine injection, USP auto-injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL in a sterile solution. Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.3 mg contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.15 mg contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4- Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of epinephrine injection, USP auto-injector with patients and caregivers prior to use [see Patient Counseling Information (17)]."
},
{
"NDCCode": "49502-195-80",
"PackageDescription": "1 VIAL in 1 CARTON (49502-195-80) > 10 mL in 1 VIAL",
"NDC11Code": "49502-0195-80",
"ProductNDC": "49502-195",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Semglee",
"NonProprietaryName": "Insulin Glargine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200831",
"EndMarketingDate": "20220731",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA210605",
"LabelerName": "Mylan Specialty L.P.",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200831",
"EndMarketingDatePackage": "20220731",
"SamplePackage": "N"
},
{
"NDCCode": "49502-196-75",
"PackageDescription": "5 SYRINGE in 1 CARTON (49502-196-75) > 3 mL in 1 SYRINGE (49502-196-35) ",
"NDC11Code": "49502-0196-75",
"ProductNDC": "49502-196",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Semglee",
"NonProprietaryName": "Insulin Glargine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200831",
"EndMarketingDate": "20221130",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA210605",
"LabelerName": "Mylan Specialty L.P.",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200831",
"EndMarketingDatePackage": "20221130",
"SamplePackage": "N"
},
{
"NDCCode": "49502-250-80",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (49502-250-80) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "49502-0250-80",
"ProductNDC": "49502-250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Semglee",
"NonProprietaryName": "Insulin Glargine-yfgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20211115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761201",
"LabelerName": "Mylan Specialty L.P.",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20211115",
"SamplePackage": "N",
"IndicationAndUsage": "SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4."
},
{
"NDCCode": "49502-251-35",
"PackageDescription": "1 SYRINGE in 1 CARTON (49502-251-35) / 3 mL in 1 SYRINGE",
"NDC11Code": "49502-0251-35",
"ProductNDC": "49502-251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Semglee",
"NonProprietaryName": "Insulin Glargine-yfgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20211115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761201",
"LabelerName": "Mylan Specialty L.P.",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241001",
"SamplePackage": "Y",
"IndicationAndUsage": "SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4."
},
{
"NDCCode": "49502-251-71",
"PackageDescription": "1 SYRINGE in 1 CARTON (49502-251-71) / 3 mL in 1 SYRINGE",
"NDC11Code": "49502-0251-71",
"ProductNDC": "49502-251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Semglee",
"NonProprietaryName": "Insulin Glargine-yfgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20211115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761201",
"LabelerName": "Mylan Specialty L.P.",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241001",
"SamplePackage": "N",
"IndicationAndUsage": "SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4."
},
{
"NDCCode": "49502-251-73",
"PackageDescription": "3 SYRINGE in 1 CARTON (49502-251-73) / 3 mL in 1 SYRINGE",
"NDC11Code": "49502-0251-73",
"ProductNDC": "49502-251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Semglee",
"NonProprietaryName": "Insulin Glargine-yfgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20211115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761201",
"LabelerName": "Mylan Specialty L.P.",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241001",
"SamplePackage": "N",
"IndicationAndUsage": "SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4."
},
{
"NDCCode": "49502-251-75",
"PackageDescription": "5 SYRINGE in 1 CARTON (49502-251-75) / 3 mL in 1 SYRINGE",
"NDC11Code": "49502-0251-75",
"ProductNDC": "49502-251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Semglee",
"NonProprietaryName": "Insulin Glargine-yfgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20211115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761201",
"LabelerName": "Mylan Specialty L.P.",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20211115",
"SamplePackage": "N",
"IndicationAndUsage": "SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4."
},
{
"NDCCode": "49502-251-98",
"PackageDescription": "3 SYRINGE in 1 CARTON (49502-251-98) / 3 mL in 1 SYRINGE",
"NDC11Code": "49502-0251-98",
"ProductNDC": "49502-251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Semglee",
"NonProprietaryName": "Insulin Glargine-yfgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20211115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761201",
"LabelerName": "Mylan Specialty L.P.",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241001",
"SamplePackage": "Y",
"IndicationAndUsage": "SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4."
},
{
"NDCCode": "49502-251-99",
"PackageDescription": "5 SYRINGE in 1 CARTON (49502-251-99) / 3 mL in 1 SYRINGE",
"NDC11Code": "49502-0251-99",
"ProductNDC": "49502-251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Semglee",
"NonProprietaryName": "Insulin Glargine-yfgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20211115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761201",
"LabelerName": "Mylan Specialty L.P.",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241001",
"SamplePackage": "Y",
"IndicationAndUsage": "SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4."
},
{
"NDCCode": "49502-345-73",
"PackageDescription": "56 POUCH in 1 CARTON (49502-345-73) / 4 AMPULE in 1 POUCH (49502-345-99) / 5 mL in 1 AMPULE",
"NDC11Code": "49502-0345-73",
"ProductNDC": "49502-345",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobi",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; RESPIRATORY (INHALATION)",
"StartMarketingDate": "20220623",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050753",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220623",
"EndMarketingDatePackage": "20261031",
"SamplePackage": "N",
"IndicationAndUsage": "TOBI is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) < 25% or > 75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].",
"Description": "TOBI® is a tobramycin solution for inhalation. It is a sterile, clear, slightly yellow, non-pyrogenic, aqueous solution with the pH and salinity adjusted specifically for administration by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.52 g/mol. Tobramycin is O-3-amino-3-deoxy-α-D‑glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6- trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine. The structural formula for tobramycin is. Each single-dose 5 mL ampoule contains 300 mg tobramycin and 11.25 mg sodium chloride in sterile water for injection. Sulfuric acid and sodium hydroxide are added to adjust the pH to 6.0. Nitrogen is used for sparging. All ingredients meet USP requirements. The formulation contains no preservatives."
},
{
"NDCCode": "49502-345-74",
"PackageDescription": "56 POUCH in 1 CARTON (49502-345-74) / 14 AMPULE in 1 POUCH (49502-345-01) / 5 mL in 1 AMPULE",
"NDC11Code": "49502-0345-74",
"ProductNDC": "49502-345",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobi",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; RESPIRATORY (INHALATION)",
"StartMarketingDate": "20220623",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050753",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260625",
"SamplePackage": "N",
"IndicationAndUsage": "TOBI is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) < 25% or > 75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].",
"Description": "TOBI® is a tobramycin solution for inhalation. It is a sterile, clear, slightly yellow, non-pyrogenic, aqueous solution with the pH and salinity adjusted specifically for administration by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.52 g/mol. Tobramycin is O-3-amino-3-deoxy-α-D‑glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6- trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine. The structural formula for tobramycin is. Each single-dose 5 mL ampoule contains 300 mg tobramycin and 11.25 mg sodium chloride in sterile water for injection. Sulfuric acid and sodium hydroxide are added to adjust the pH to 6.0. Nitrogen is used for sparging. All ingredients meet USP requirements. The formulation contains no preservatives."
},
{
"NDCCode": "49502-346-24",
"PackageDescription": "224 PACKAGE in 1 BOX, UNIT-DOSE (49502-346-24) > 56 BLISTER PACK in 1 PACKAGE > 4 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "49502-0346-24",
"ProductNDC": "49502-346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobi Podhaler",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL; RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200924",
"EndMarketingDate": "20230531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201688",
"LabelerName": "Mylan Specialty L.P.",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "28",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200924",
"EndMarketingDatePackage": "20230531",
"SamplePackage": "N"
},
{
"NDCCode": "49502-346-57",
"PackageDescription": "7 BLISTER PACK in 1 BOX, UNIT-DOSE (49502-346-57) > 8 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "49502-0346-57",
"ProductNDC": "49502-346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobi Podhaler",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL; RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200924",
"EndMarketingDate": "20301231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201688",
"LabelerName": "Mylan Specialty L.P.",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "28",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210723",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "Y"
},
{
"NDCCode": "49502-378-15",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (49502-378-15) / 150 mL in 1 BOTTLE, GLASS",
"NDC11Code": "49502-0378-15",
"ProductNDC": "49502-378",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ermeza",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20221214",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215809",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "30",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221214",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. ERMEZA is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. ERMEZA is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: : 1 ERMEZA is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with ERMEZA may induce hyperthyroidism [see Warnings and Precautions (5.1)]. , 2 ERMEZA is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. .",
"Description": "ERMEZA (levothyroxine sodium) oral solution contains synthetic L-3,3', 5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland, and is very slightly soluble in water. Levothyroxine (T4) sodium hydrate has an empirical formula of C15H10I4NNaO4 with x ≈ 5*, molecular weight of 798.86 (anhydrous), and structural formula as shown. ERMEZA oral solution is supplied in the following strength: 150 mcg/5 mL (30 mcg/mL). ERMEZA oral solution contains the following inactive ingredients: edetate disodium, glycerin, and purified water."
},
{
"NDCCode": "49502-378-75",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (49502-378-75) / 75 mL in 1 BOTTLE, GLASS",
"NDC11Code": "49502-0378-75",
"ProductNDC": "49502-378",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ermeza",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20221214",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215809",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "30",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221214",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. ERMEZA is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. ERMEZA is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: : 1 ERMEZA is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with ERMEZA may induce hyperthyroidism [see Warnings and Precautions (5.1)]. , 2 ERMEZA is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. .",
"Description": "ERMEZA (levothyroxine sodium) oral solution contains synthetic L-3,3', 5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland, and is very slightly soluble in water. Levothyroxine (T4) sodium hydrate has an empirical formula of C15H10I4NNaO4 with x ≈ 5*, molecular weight of 798.86 (anhydrous), and structural formula as shown. ERMEZA oral solution is supplied in the following strength: 150 mcg/5 mL (30 mcg/mL). ERMEZA oral solution contains the following inactive ingredients: edetate disodium, glycerin, and purified water."
},
{
"NDCCode": "49502-380-02",
"PackageDescription": "2 TRAY in 1 KIT (49502-380-02) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT (49502-540-06) / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT (49502-542-06) / 1 mL in 1 PACKET",
"NDC11Code": "49502-0380-02",
"ProductNDC": "49502-380",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hulio",
"NonProprietaryName": "Adalimumab-fkjp",
"DosageFormName": "KIT",
"StartMarketingDate": "20230701",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761154",
"LabelerName": "Viatris Specialty LLC",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230701",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "HULIO is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): 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 RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 8 Plaque Psoriasis (Ps) (1.7): 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., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.",
"Description": "Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) 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. HULIO (adalimumab-fkjp) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HULIO Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of HULIO is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HULIO contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HULIO contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH."
},
{
"NDCCode": "49502-381-02",
"PackageDescription": "2 TRAY in 1 KIT (49502-381-02) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT (49502-567-06) / 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 2 PACKET in 1 KIT (49502-569-02) / 1 mL in 1 PACKET",
"NDC11Code": "49502-0381-02",
"ProductNDC": "49502-381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hulio",
"NonProprietaryName": "Adalimumab-fkjp",
"DosageFormName": "KIT",
"StartMarketingDate": "20230701",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761154",
"LabelerName": "Viatris Specialty LLC",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230701",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "HULIO is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): 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 RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 8 Plaque Psoriasis (Ps) (1.7): 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., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.",
"Description": "Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) 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. HULIO (adalimumab-fkjp) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HULIO Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of HULIO is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HULIO contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HULIO contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH."
},
{
"NDCCode": "49502-382-02",
"PackageDescription": "2 TRAY in 1 KIT (49502-382-02) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT (49502-554-06) / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT (49502-556-06) / 1 mL in 1 PACKET",
"NDC11Code": "49502-0382-02",
"ProductNDC": "49502-382",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hulio",
"NonProprietaryName": "Adalimumab-fkjp",
"DosageFormName": "KIT",
"StartMarketingDate": "20230701",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761154",
"LabelerName": "Viatris Specialty LLC",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230701",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "HULIO is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): 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 RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 8 Plaque Psoriasis (Ps) (1.7): 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., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.",
"Description": "Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) 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. HULIO (adalimumab-fkjp) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HULIO Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of HULIO is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HULIO contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HULIO contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH."
},
{
"NDCCode": "49502-393-80",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (49502-393-80) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "49502-0393-80",
"ProductNDC": "49502-393",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Insulin Glargine",
"NonProprietaryName": "Insulin Glargine-yfgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20211116",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761201",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211116",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. Insulin Glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. Insulin Glargine-yfgn is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. Insulin Glargine-yfgn has a pH of approximately 4."
},
{
"NDCCode": "49502-394-75",
"PackageDescription": "5 SYRINGE in 1 CARTON (49502-394-75) / 3 mL in 1 SYRINGE (49502-394-71) ",
"NDC11Code": "49502-0394-75",
"ProductNDC": "49502-394",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Insulin Glargine",
"NonProprietaryName": "Insulin Glargine-yfgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20211116",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761201",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211116",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. Insulin Glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. Insulin Glargine-yfgn is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. Insulin Glargine-yfgn has a pH of approximately 4."
}
]
}
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<NDCList>
<NDC>
<NDCCode>49502-501-92</NDCCode>
<PackageDescription>2 CONTAINER in 1 CARTON (49502-501-92) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>49502-0501-92</NDC11Code>
<ProductNDC>49502-501</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epipen Jr</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19871222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019430</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19871222</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EpiPen and EpiPen Jr are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. EpiPen and EpiPen Jr are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. EpiPen and EpiPen Jr are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.</IndicationAndUsage>
<Description>EpiPen (epinephrine injection, USP) 0.3 mg and EpiPen Jr (epinephrine injection, USP) 0.15 mg are single-dose auto-injectors and combination products containing drug and device components. Each EpiPen Auto-Injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL in a sterile solution. Each EpiPen Jr Auto-Injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL in a sterile solution. Each 0.3 mL in the EpiPen Auto-Injector contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Each 0.3 mL in the EpiPen Jr Auto-Injector contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4- Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace EpiPen and EpiPen Jr if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of EpiPen or EpiPen Jr with patients and caregivers prior to use [see Patient Counseling Information (17)].</Description>
</NDC>
<NDC>
<NDCCode>49502-500-92</NDCCode>
<PackageDescription>2 CONTAINER in 1 CARTON (49502-500-92) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>49502-0500-92</NDC11Code>
<ProductNDC>49502-500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epipen</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19871222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019430</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19871222</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EpiPen and EpiPen Jr are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. EpiPen and EpiPen Jr are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. EpiPen and EpiPen Jr are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.</IndicationAndUsage>
<Description>EpiPen (epinephrine injection, USP) 0.3 mg and EpiPen Jr (epinephrine injection, USP) 0.15 mg are single-dose auto-injectors and combination products containing drug and device components. Each EpiPen Auto-Injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL in a sterile solution. Each EpiPen Jr Auto-Injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL in a sterile solution. Each 0.3 mL in the EpiPen Auto-Injector contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Each 0.3 mL in the EpiPen Jr Auto-Injector contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4- Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace EpiPen and EpiPen Jr if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of EpiPen or EpiPen Jr with patients and caregivers prior to use [see Patient Counseling Information (17)].</Description>
</NDC>
<NDC>
<NDCCode>71610-501-92</NDCCode>
<PackageDescription>270 TABLET in 1 BOTTLE (71610-501-92) </PackageDescription>
<NDC11Code>71610-0501-92</NDC11Code>
<ProductNDC>71610-501</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibu</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075682</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.</IndicationAndUsage>
<Description>IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powde rwith a melting point of 74-77° C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. IBU, a nonsteroidal anti-inflammatory drug (NSAID), is availablein 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystallinecellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>49502-501-01</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (49502-501-01) > 1 SYRINGE, GLASS in 1 CONTAINER > .3 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>49502-0501-01</NDC11Code>
<ProductNDC>49502-501</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epipen Jr</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19871222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019430</ApplicationNumber>
<LabelerName>Mylan Specialty L.P.</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>49502-501-02</NDCCode>
<PackageDescription>2 CONTAINER in 1 CARTON (49502-501-02) / 1 SYRINGE, GLASS in 1 CONTAINER (49502-501-01) / .3 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>49502-0501-02</NDC11Code>
<ProductNDC>49502-501</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epipen Jr</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19871222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019430</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19871222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EpiPen and EpiPen Jr are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. EpiPen and EpiPen Jr are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. EpiPen and EpiPen Jr are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.</IndicationAndUsage>
<Description>EpiPen (epinephrine injection, USP) 0.3 mg and EpiPen Jr (epinephrine injection, USP) 0.15 mg are single-dose auto-injectors and combination products containing drug and device components. Each EpiPen Auto-Injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL in a sterile solution. Each EpiPen Jr Auto-Injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL in a sterile solution. Each 0.3 mL in the EpiPen Auto-Injector contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Each 0.3 mL in the EpiPen Jr Auto-Injector contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4- Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace EpiPen and EpiPen Jr if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of EpiPen or EpiPen Jr with patients and caregivers prior to use [see Patient Counseling Information (17)].</Description>
</NDC>
<NDC>
<NDCCode>49502-605-05</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (49502-605-05) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>49502-0605-05</NDC11Code>
<ProductNDC>49502-605</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perforomist</ProprietaryName>
<NonProprietaryName>Formoterol Fumarate Dihydrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20071001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022007</ApplicationNumber>
<LabelerName>Mylan Specialty L.P.</LabelerName>
<SubstanceName>FORMOTEROL FUMARATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>ug/2mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071001</StartMarketingDatePackage>
<EndMarketingDatePackage>20230630</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>PERFOROMIST Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).</IndicationAndUsage>
<Description>PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of PERFOROMIST Inhalation Solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is. Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C19H24N2O4)2C4H4O42H2O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. PERFOROMIST Inhalation Solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) connected to a PRONEB® Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. PERFOROMIST Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece.</Description>
</NDC>
<NDC>
<NDCCode>49502-605-30</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (49502-605-30) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>49502-0605-30</NDC11Code>
<ProductNDC>49502-605</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perforomist</ProprietaryName>
<NonProprietaryName>Formoterol Fumarate Dihydrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20071001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022007</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>FORMOTEROL FUMARATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>ug/2mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PERFOROMIST Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).</IndicationAndUsage>
<Description>PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of PERFOROMIST Inhalation Solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is. Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C19H24N2O4)2C4H4O42H2O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. PERFOROMIST Inhalation Solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) connected to a PRONEB® Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. PERFOROMIST Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece.</Description>
</NDC>
<NDC>
<NDCCode>49502-605-61</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (49502-605-61) / 1 VIAL in 1 POUCH (49502-605-95) / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>49502-0605-61</NDC11Code>
<ProductNDC>49502-605</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perforomist</ProprietaryName>
<NonProprietaryName>Formoterol Fumarate Dihydrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20071001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022007</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>FORMOTEROL FUMARATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>ug/2mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PERFOROMIST Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).</IndicationAndUsage>
<Description>PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of PERFOROMIST Inhalation Solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is. Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C19H24N2O4)2C4H4O42H2O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. PERFOROMIST Inhalation Solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) connected to a PRONEB® Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. PERFOROMIST Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece.</Description>
</NDC>
<NDC>
<NDCCode>49502-101-02</NDCCode>
<PackageDescription>2 CONTAINER in 1 CARTON (49502-101-02) / 1 SYRINGE, GLASS in 1 CONTAINER (49502-101-01) / .3 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>49502-0101-02</NDC11Code>
<ProductNDC>49502-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrine</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20161215</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019430</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Epinephrine injection, USP auto-injectors are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine injection, USP auto-injectors are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. Epinephrine injection, USP auto-injectors are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.</IndicationAndUsage>
<Description>Epinephrine injection, USP auto-injectors, 0.3 mg and 0.15 mg, are single-dose auto-injectors and combination products containing drug and device components. Each epinephrine injection, USP auto-injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL in a sterile solution. Each epinephrine injection, USP auto-injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL in a sterile solution. Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.3 mg contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.15 mg contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4- Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of epinephrine injection, USP auto-injector with patients and caregivers prior to use [see Patient Counseling Information (17)].</Description>
</NDC>
<NDC>
<NDCCode>49502-102-02</NDCCode>
<PackageDescription>2 CONTAINER in 1 CARTON (49502-102-02) / 1 SYRINGE, GLASS in 1 CONTAINER (49502-102-01) / .3 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>49502-0102-02</NDC11Code>
<ProductNDC>49502-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrine</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20161215</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019430</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Epinephrine injection, USP auto-injectors are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine injection, USP auto-injectors are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. Epinephrine injection, USP auto-injectors are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.</IndicationAndUsage>
<Description>Epinephrine injection, USP auto-injectors, 0.3 mg and 0.15 mg, are single-dose auto-injectors and combination products containing drug and device components. Each epinephrine injection, USP auto-injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL in a sterile solution. Each epinephrine injection, USP auto-injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL in a sterile solution. Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.3 mg contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.15 mg contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4- Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of epinephrine injection, USP auto-injector with patients and caregivers prior to use [see Patient Counseling Information (17)].</Description>
</NDC>
<NDC>
<NDCCode>49502-195-80</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (49502-195-80) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>49502-0195-80</NDC11Code>
<ProductNDC>49502-195</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Semglee</ProprietaryName>
<NonProprietaryName>Insulin Glargine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200831</StartMarketingDate>
<EndMarketingDate>20220731</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA210605</ApplicationNumber>
<LabelerName>Mylan Specialty L.P.</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200831</StartMarketingDatePackage>
<EndMarketingDatePackage>20220731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49502-196-75</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (49502-196-75) > 3 mL in 1 SYRINGE (49502-196-35) </PackageDescription>
<NDC11Code>49502-0196-75</NDC11Code>
<ProductNDC>49502-196</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Semglee</ProprietaryName>
<NonProprietaryName>Insulin Glargine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200831</StartMarketingDate>
<EndMarketingDate>20221130</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA210605</ApplicationNumber>
<LabelerName>Mylan Specialty L.P.</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200831</StartMarketingDatePackage>
<EndMarketingDatePackage>20221130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49502-250-80</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (49502-250-80) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>49502-0250-80</NDC11Code>
<ProductNDC>49502-250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Semglee</ProprietaryName>
<NonProprietaryName>Insulin Glargine-yfgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20211115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761201</ApplicationNumber>
<LabelerName>Mylan Specialty L.P.</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>49502-251-35</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (49502-251-35) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>49502-0251-35</NDC11Code>
<ProductNDC>49502-251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Semglee</ProprietaryName>
<NonProprietaryName>Insulin Glargine-yfgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20211115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761201</ApplicationNumber>
<LabelerName>Mylan Specialty L.P.</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241001</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>49502-251-71</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (49502-251-71) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>49502-0251-71</NDC11Code>
<ProductNDC>49502-251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Semglee</ProprietaryName>
<NonProprietaryName>Insulin Glargine-yfgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20211115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761201</ApplicationNumber>
<LabelerName>Mylan Specialty L.P.</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>49502-251-73</NDCCode>
<PackageDescription>3 SYRINGE in 1 CARTON (49502-251-73) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>49502-0251-73</NDC11Code>
<ProductNDC>49502-251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Semglee</ProprietaryName>
<NonProprietaryName>Insulin Glargine-yfgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20211115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761201</ApplicationNumber>
<LabelerName>Mylan Specialty L.P.</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>49502-251-75</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (49502-251-75) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>49502-0251-75</NDC11Code>
<ProductNDC>49502-251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Semglee</ProprietaryName>
<NonProprietaryName>Insulin Glargine-yfgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20211115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761201</ApplicationNumber>
<LabelerName>Mylan Specialty L.P.</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>49502-251-98</NDCCode>
<PackageDescription>3 SYRINGE in 1 CARTON (49502-251-98) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>49502-0251-98</NDC11Code>
<ProductNDC>49502-251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Semglee</ProprietaryName>
<NonProprietaryName>Insulin Glargine-yfgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20211115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761201</ApplicationNumber>
<LabelerName>Mylan Specialty L.P.</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241001</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>49502-251-99</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (49502-251-99) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>49502-0251-99</NDC11Code>
<ProductNDC>49502-251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Semglee</ProprietaryName>
<NonProprietaryName>Insulin Glargine-yfgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20211115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761201</ApplicationNumber>
<LabelerName>Mylan Specialty L.P.</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241001</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>49502-345-73</NDCCode>
<PackageDescription>56 POUCH in 1 CARTON (49502-345-73) / 4 AMPULE in 1 POUCH (49502-345-99) / 5 mL in 1 AMPULE</PackageDescription>
<NDC11Code>49502-0345-73</NDC11Code>
<ProductNDC>49502-345</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobi</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20220623</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050753</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>TOBRAMYCIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220623</StartMarketingDatePackage>
<EndMarketingDatePackage>20261031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TOBI is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) < 25% or > 75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].</IndicationAndUsage>
<Description>TOBI® is a tobramycin solution for inhalation. It is a sterile, clear, slightly yellow, non-pyrogenic, aqueous solution with the pH and salinity adjusted specifically for administration by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.52 g/mol. Tobramycin is O-3-amino-3-deoxy-α-D‑glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6- trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine. The structural formula for tobramycin is. Each single-dose 5 mL ampoule contains 300 mg tobramycin and 11.25 mg sodium chloride in sterile water for injection. Sulfuric acid and sodium hydroxide are added to adjust the pH to 6.0. Nitrogen is used for sparging. All ingredients meet USP requirements. The formulation contains no preservatives.</Description>
</NDC>
<NDC>
<NDCCode>49502-345-74</NDCCode>
<PackageDescription>56 POUCH in 1 CARTON (49502-345-74) / 14 AMPULE in 1 POUCH (49502-345-01) / 5 mL in 1 AMPULE</PackageDescription>
<NDC11Code>49502-0345-74</NDC11Code>
<ProductNDC>49502-345</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobi</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20220623</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050753</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>TOBRAMYCIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TOBI is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) < 25% or > 75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].</IndicationAndUsage>
<Description>TOBI® is a tobramycin solution for inhalation. It is a sterile, clear, slightly yellow, non-pyrogenic, aqueous solution with the pH and salinity adjusted specifically for administration by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.52 g/mol. Tobramycin is O-3-amino-3-deoxy-α-D‑glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6- trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine. The structural formula for tobramycin is. Each single-dose 5 mL ampoule contains 300 mg tobramycin and 11.25 mg sodium chloride in sterile water for injection. Sulfuric acid and sodium hydroxide are added to adjust the pH to 6.0. Nitrogen is used for sparging. All ingredients meet USP requirements. The formulation contains no preservatives.</Description>
</NDC>
<NDC>
<NDCCode>49502-346-24</NDCCode>
<PackageDescription>224 PACKAGE in 1 BOX, UNIT-DOSE (49502-346-24) > 56 BLISTER PACK in 1 PACKAGE > 4 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>49502-0346-24</NDC11Code>
<ProductNDC>49502-346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobi Podhaler</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL; RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200924</StartMarketingDate>
<EndMarketingDate>20230531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201688</ApplicationNumber>
<LabelerName>Mylan Specialty L.P.</LabelerName>
<SubstanceName>TOBRAMYCIN</SubstanceName>
<StrengthNumber>28</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200924</StartMarketingDatePackage>
<EndMarketingDatePackage>20230531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49502-346-57</NDCCode>
<PackageDescription>7 BLISTER PACK in 1 BOX, UNIT-DOSE (49502-346-57) > 8 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>49502-0346-57</NDC11Code>
<ProductNDC>49502-346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobi Podhaler</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL; RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200924</StartMarketingDate>
<EndMarketingDate>20301231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201688</ApplicationNumber>
<LabelerName>Mylan Specialty L.P.</LabelerName>
<SubstanceName>TOBRAMYCIN</SubstanceName>
<StrengthNumber>28</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210723</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>49502-378-15</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (49502-378-15) / 150 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>49502-0378-15</NDC11Code>
<ProductNDC>49502-378</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ermeza</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221214</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215809</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221214</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. ERMEZA is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. ERMEZA is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: : 1 ERMEZA is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with ERMEZA may induce hyperthyroidism [see Warnings and Precautions (5.1)]. , 2 ERMEZA is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. .</IndicationAndUsage>
<Description>ERMEZA (levothyroxine sodium) oral solution contains synthetic L-3,3', 5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland, and is very slightly soluble in water. Levothyroxine (T4) sodium hydrate has an empirical formula of C15H10I4NNaO4 with x ≈ 5*, molecular weight of 798.86 (anhydrous), and structural formula as shown. ERMEZA oral solution is supplied in the following strength: 150 mcg/5 mL (30 mcg/mL). ERMEZA oral solution contains the following inactive ingredients: edetate disodium, glycerin, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>49502-378-75</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (49502-378-75) / 75 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>49502-0378-75</NDC11Code>
<ProductNDC>49502-378</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ermeza</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221214</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215809</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221214</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. ERMEZA is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. ERMEZA is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: : 1 ERMEZA is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with ERMEZA may induce hyperthyroidism [see Warnings and Precautions (5.1)]. , 2 ERMEZA is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. .</IndicationAndUsage>
<Description>ERMEZA (levothyroxine sodium) oral solution contains synthetic L-3,3', 5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland, and is very slightly soluble in water. Levothyroxine (T4) sodium hydrate has an empirical formula of C15H10I4NNaO4 with x ≈ 5*, molecular weight of 798.86 (anhydrous), and structural formula as shown. ERMEZA oral solution is supplied in the following strength: 150 mcg/5 mL (30 mcg/mL). ERMEZA oral solution contains the following inactive ingredients: edetate disodium, glycerin, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>49502-380-02</NDCCode>
<PackageDescription>2 TRAY in 1 KIT (49502-380-02) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT (49502-540-06) / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT (49502-542-06) / 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>49502-0380-02</NDC11Code>
<ProductNDC>49502-380</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hulio</ProprietaryName>
<NonProprietaryName>Adalimumab-fkjp</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230701</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761154</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230701</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HULIO is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): 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 RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 8 Plaque Psoriasis (Ps) (1.7): 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., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.</IndicationAndUsage>
<Description>Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) 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. HULIO (adalimumab-fkjp) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HULIO Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of HULIO is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HULIO contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HULIO contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>49502-381-02</NDCCode>
<PackageDescription>2 TRAY in 1 KIT (49502-381-02) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT (49502-567-06) / 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 2 PACKET in 1 KIT (49502-569-02) / 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>49502-0381-02</NDC11Code>
<ProductNDC>49502-381</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hulio</ProprietaryName>
<NonProprietaryName>Adalimumab-fkjp</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230701</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761154</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230701</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HULIO is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): 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 RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 8 Plaque Psoriasis (Ps) (1.7): 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., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.</IndicationAndUsage>
<Description>Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) 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. HULIO (adalimumab-fkjp) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HULIO Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of HULIO is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HULIO contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HULIO contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>49502-382-02</NDCCode>
<PackageDescription>2 TRAY in 1 KIT (49502-382-02) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT (49502-554-06) / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT (49502-556-06) / 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>49502-0382-02</NDC11Code>
<ProductNDC>49502-382</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hulio</ProprietaryName>
<NonProprietaryName>Adalimumab-fkjp</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230701</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761154</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230701</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HULIO is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): 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 RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 8 Plaque Psoriasis (Ps) (1.7): 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., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.</IndicationAndUsage>
<Description>Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) 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. HULIO (adalimumab-fkjp) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HULIO Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of HULIO is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HULIO contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HULIO contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>49502-393-80</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (49502-393-80) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>49502-0393-80</NDC11Code>
<ProductNDC>49502-393</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Insulin Glargine</ProprietaryName>
<NonProprietaryName>Insulin Glargine-yfgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20211116</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761201</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211116</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. Insulin Glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. Insulin Glargine-yfgn is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. Insulin Glargine-yfgn has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>49502-394-75</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (49502-394-75) / 3 mL in 1 SYRINGE (49502-394-71) </PackageDescription>
<NDC11Code>49502-0394-75</NDC11Code>
<ProductNDC>49502-394</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Insulin Glargine</ProprietaryName>
<NonProprietaryName>Insulin Glargine-yfgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20211116</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761201</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211116</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. Insulin Glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. Insulin Glargine-yfgn is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. Insulin Glargine-yfgn has a pH of approximately 4.</Description>
</NDC>
</NDCList>