{
"NDC": [
{
"NDCCode": "35573-443-25",
"PackageDescription": "25 POUCH in 1 CARTON (35573-443-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "35573-0443-25",
"ProductNDC": "35573-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levalbuterol",
"NonProprietaryName": "Levalbuterol Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20210401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203653",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
"StrengthNumber": ".31",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210401",
"SamplePackage": "N",
"IndicationAndUsage": "Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.",
"Description": "Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) or 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) or 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5)."
},
{
"NDCCode": "35573-444-25",
"PackageDescription": "25 POUCH in 1 CARTON (35573-444-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "35573-0444-25",
"ProductNDC": "35573-444",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levalbuterol",
"NonProprietaryName": "Levalbuterol Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20210401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203653",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
"StrengthNumber": ".63",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210401",
"SamplePackage": "N",
"IndicationAndUsage": "Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.",
"Description": "Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) or 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) or 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5)."
},
{
"NDCCode": "35573-445-25",
"PackageDescription": "25 POUCH in 1 CARTON (35573-445-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "35573-0445-25",
"ProductNDC": "35573-445",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levalbuterol",
"NonProprietaryName": "Levalbuterol Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20210401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203653",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210401",
"SamplePackage": "N",
"IndicationAndUsage": "Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.",
"Description": "Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) or 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) or 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5)."
},
{
"NDCCode": "52904-443-50",
"PackageDescription": "25 CARTON in 1 BOX (52904-443-50) > 1 PACKET in 1 CARTON (52904-443-06) > 2 TABLET in 1 PACKET (52904-443-02) ",
"NDC11Code": "52904-0443-50",
"ProductNDC": "52904-443",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stomach Relief Anti Diarrheal",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074091",
"LabelerName": "Select Corporation",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20121015",
"SamplePackage": "N",
"IndicationAndUsage": " controls the symptoms of diarrhea, including Travelers’ Diarrhea."
},
{
"NDCCode": "60966-443-01",
"PackageDescription": "25 g in 1 PACKAGE (60966-443-01)",
"NDC11Code": "60966-0443-01",
"ProductNDC": "60966-443",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Methimazole",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140606",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Huron Pharmaceuticals",
"SubstanceName": "METHIMAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "62157-443-01",
"PackageDescription": "25 kg in 1 DRUM (62157-443-01)",
"NDC11Code": "62157-0443-01",
"ProductNDC": "62157-443",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Praziquantel",
"DosageFormName": "POWDER",
"StartMarketingDate": "20170719",
"MarketingCategoryName": "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING",
"LabelerName": "AX Pharmaceutical Corp",
"SubstanceName": "PRAZIQUANTEL",
"StrengthNumber": "24.75",
"StrengthUnit": "kg/25kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "63739-443-01",
"PackageDescription": "25 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-443-01) > 30 TABLET in 1 BLISTER PACK",
"NDC11Code": "63739-0443-01",
"ProductNDC": "63739-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibu",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075682",
"LabelerName": "McKesson Packaging Services a business unit of McKesson Corporation",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-04-18"
},
{
"NDCCode": "73069-443-17",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-443-17) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-17",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-25",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 BOX (73069-443-25) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-25",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-27",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-443-27) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-27",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-37",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-443-37) > 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-37",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-47",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-443-47) > 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-47",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-57",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-443-57) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-57",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-67",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-443-67) > 30 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-67",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-77",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-443-77) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-77",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
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{
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"LabelerName": "VIATREXX BIO INCORPORATED",
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{
"NDCCode": "85828-443-25",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acid Reducer",
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"RouteName": "ORAL",
"StartMarketingDate": "20260320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215822",
"LabelerName": "Grocery Outlet",
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"StartMarketingDatePackage": "20260320",
"SamplePackage": "N",
"IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages."
},
{
"NDCCode": "35573-415-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (35573-415-30) ",
"NDC11Code": "35573-0415-30",
"ProductNDC": "35573-415",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
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"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "35573-416-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (35573-416-30) ",
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"ProductNDC": "35573-416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
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"ApplicationNumber": "ANDA079016",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
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"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
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"PackageDescription": "30 CAPSULE in 1 BOTTLE (35573-417-30) ",
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"ProductNDC": "35573-417",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
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"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
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"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
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},
{
"NDCCode": "35573-418-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (35573-418-30) ",
"NDC11Code": "35573-0418-30",
"ProductNDC": "35573-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "35573-419-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (35573-419-30) ",
"NDC11Code": "35573-0419-30",
"ProductNDC": "35573-419",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
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"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
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"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
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{
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"PackageDescription": "30 CAPSULE in 1 BOTTLE (35573-420-30) ",
"NDC11Code": "35573-0420-30",
"ProductNDC": "35573-420",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "35573-421-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (35573-421-30) ",
"NDC11Code": "35573-0421-30",
"ProductNDC": "35573-421",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "35573-436-02",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (35573-436-02) ",
"NDC11Code": "35573-0436-02",
"ProductNDC": "35573-436",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loxapine",
"NonProprietaryName": "Loxapine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076868",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "LOXAPINE SUCCINATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210501",
"SamplePackage": "N",
"IndicationAndUsage": "Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.",
"Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "35573-437-02",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (35573-437-02) ",
"NDC11Code": "35573-0437-02",
"ProductNDC": "35573-437",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loxapine",
"NonProprietaryName": "Loxapine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076868",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "LOXAPINE SUCCINATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210501",
"SamplePackage": "N",
"IndicationAndUsage": "Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.",
"Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "35573-438-02",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (35573-438-02) ",
"NDC11Code": "35573-0438-02",
"ProductNDC": "35573-438",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loxapine",
"NonProprietaryName": "Loxapine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076868",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "LOXAPINE SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20210501",
"SamplePackage": "N",
"IndicationAndUsage": "Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.",
"Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "35573-439-02",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (35573-439-02) ",
"NDC11Code": "35573-0439-02",
"ProductNDC": "35573-439",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loxapine",
"NonProprietaryName": "Loxapine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076868",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "LOXAPINE SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210501",
"SamplePackage": "N",
"IndicationAndUsage": "Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.",
"Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "35573-464-02",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-464-02) ",
"NDC11Code": "35573-0464-02",
"ProductNDC": "35573-464",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191216",
"EndMarketingDate": "20280229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212037",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE",
"StrengthNumber": "1.25; 1.25; 1.25; 1.25",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20280229",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. (1).",
"Description": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Inactive Ingredients and ColorsThe inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: ferric oxide red, ferric oxide yellow, gelatin capsules, hypromellose 2910/3 cP, 6 cP and 50 cP, methacrylic acid and ethyl acrylate copolymer, titanium dioxide, polyethylene glycol, polysorbate 80, sugar spheres, talc, and triethyl citrate. The 5 mg gelatin capsules contain gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1 and FD&C yellow #6. The 10 mg gelatin capsules contain gelatin, FD&C blue #1, and FD&C red #40. The 15 mg gelatin capsules contain gelatin, titanium dioxide, FD&C blue #1, and FD&C yellow #6. The 20 mg gelatin capsules contain gelatin, titanium dioxide, and FD&C red #3. The 25 mg gelatin capsules contain gelatin, FD&C red #40, and FD&C yellow #6. The 30 mg gelatin capsules contain gelatin, titanium dioxide, D&C red #28, and FD&C red #40. The ink ingredients are common for all strengths: the capsule imprint black ink contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, propylene glycol, and shellac."
},
{
"NDCCode": "35573-465-02",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-465-02) ",
"NDC11Code": "35573-0465-02",
"ProductNDC": "35573-465",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191216",
"EndMarketingDate": "20280229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212037",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE",
"StrengthNumber": "2.5; 2.5; 2.5; 2.5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20280229",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. (1).",
"Description": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Inactive Ingredients and ColorsThe inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: ferric oxide red, ferric oxide yellow, gelatin capsules, hypromellose 2910/3 cP, 6 cP and 50 cP, methacrylic acid and ethyl acrylate copolymer, titanium dioxide, polyethylene glycol, polysorbate 80, sugar spheres, talc, and triethyl citrate. The 5 mg gelatin capsules contain gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1 and FD&C yellow #6. The 10 mg gelatin capsules contain gelatin, FD&C blue #1, and FD&C red #40. The 15 mg gelatin capsules contain gelatin, titanium dioxide, FD&C blue #1, and FD&C yellow #6. The 20 mg gelatin capsules contain gelatin, titanium dioxide, and FD&C red #3. The 25 mg gelatin capsules contain gelatin, FD&C red #40, and FD&C yellow #6. The 30 mg gelatin capsules contain gelatin, titanium dioxide, D&C red #28, and FD&C red #40. The ink ingredients are common for all strengths: the capsule imprint black ink contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, propylene glycol, and shellac."
}
]
}
{"NDC":[{"NDCCode":"35573-443-25","ProprietaryName":"Levalbuterol","NonProprietaryName":"Levalbuterol Hydrochloride"},{"NDCCode":"35573-444-25","ProprietaryName":"Levalbuterol","NonProprietaryName":"Levalbuterol Hydrochloride"},{"NDCCode":"35573-445-25","ProprietaryName":"Levalbuterol","NonProprietaryName":"Levalbuterol Hydrochloride"},{"NDCCode":"52904-443-50","ProprietaryName":"Stomach Relief Anti Diarrheal","NonProprietaryName":"Loperamide Hydrochloride"},{"NDCCode":"60966-443-01","NonProprietaryName":"Methimazole"},{"NDCCode":"62157-443-01","NonProprietaryName":"Praziquantel"},{"NDCCode":"63739-443-01","ProprietaryName":"Ibu","NonProprietaryName":"Ibuprofen"},{"NDCCode":"73069-443-17","ProprietaryName":"Viatrexx-prolo","NonProprietaryName":"Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, 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<NDCCode>35573-443-25</NDCCode>
<PackageDescription>25 POUCH in 1 CARTON (35573-443-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>35573-0443-25</NDC11Code>
<ProductNDC>35573-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levalbuterol</ProprietaryName>
<NonProprietaryName>Levalbuterol Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20210401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203653</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.31</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
<Description>Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) or 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) or 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5).</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StartMarketingDate>20210401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203653</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.63</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
<Description>Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) or 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) or 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5).</Description>
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<PackageDescription>25 POUCH in 1 CARTON (35573-445-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
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<ProductNDC>35573-445</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levalbuterol</ProprietaryName>
<NonProprietaryName>Levalbuterol Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20210401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203653</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
<Description>Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) or 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) or 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5).</Description>
</NDC>
<NDC>
<NDCCode>52904-443-50</NDCCode>
<PackageDescription>25 CARTON in 1 BOX (52904-443-50) > 1 PACKET in 1 CARTON (52904-443-06) > 2 TABLET in 1 PACKET (52904-443-02) </PackageDescription>
<NDC11Code>52904-0443-50</NDC11Code>
<ProductNDC>52904-443</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stomach Relief Anti Diarrheal</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074091</ApplicationNumber>
<LabelerName>Select Corporation</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> controls the symptoms of diarrhea, including Travelers’ Diarrhea.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60966-443-01</NDCCode>
<PackageDescription>25 g in 1 PACKAGE (60966-443-01)</PackageDescription>
<NDC11Code>60966-0443-01</NDC11Code>
<ProductNDC>60966-443</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Methimazole</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140606</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Huron Pharmaceuticals</LabelerName>
<SubstanceName>METHIMAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62157-443-01</NDCCode>
<PackageDescription>25 kg in 1 DRUM (62157-443-01)</PackageDescription>
<NDC11Code>62157-0443-01</NDC11Code>
<ProductNDC>62157-443</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Praziquantel</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20170719</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING</MarketingCategoryName>
<LabelerName>AX Pharmaceutical Corp</LabelerName>
<SubstanceName>PRAZIQUANTEL</SubstanceName>
<StrengthNumber>24.75</StrengthNumber>
<StrengthUnit>kg/25kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63739-443-01</NDCCode>
<PackageDescription>25 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-443-01) > 30 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63739-0443-01</NDC11Code>
<ProductNDC>63739-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibu</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075682</ApplicationNumber>
<LabelerName>McKesson Packaging Services a business unit of McKesson Corporation</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-04-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>73069-443-17</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-443-17) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-17</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
<NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-443-25</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 BOX (73069-443-25) > 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-25</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
<NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-443-27</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-443-27) > 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-27</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
<NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-443-37</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-443-37) > 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-37</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
<NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
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<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-443-47</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-443-47) > 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-47</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
<NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-443-57</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-443-57) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-57</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
<NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-443-67</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-443-67) > 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-67</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
<NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
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<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-443-77</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-443-77) > 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-77</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
<NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-443-87</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-443-87) > 100 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-87</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
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<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
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<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>85828-443-25</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (85828-443-25) / 25 TABLET in 1 BOTTLE</PackageDescription>
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<ProprietaryName>Acid Reducer</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215822</ApplicationNumber>
<LabelerName>Grocery Outlet</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35573-415-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (35573-415-30) </PackageDescription>
<NDC11Code>35573-0415-30</NDC11Code>
<ProductNDC>35573-415</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>35573-416-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (35573-416-30) </PackageDescription>
<NDC11Code>35573-0416-30</NDC11Code>
<ProductNDC>35573-416</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>35573-417-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (35573-417-30) </PackageDescription>
<NDC11Code>35573-0417-30</NDC11Code>
<ProductNDC>35573-417</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>35573-418-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (35573-418-30) </PackageDescription>
<NDC11Code>35573-0418-30</NDC11Code>
<ProductNDC>35573-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>35573-419-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (35573-419-30) </PackageDescription>
<NDC11Code>35573-0419-30</NDC11Code>
<ProductNDC>35573-419</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>35573-420-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (35573-420-30) </PackageDescription>
<NDC11Code>35573-0420-30</NDC11Code>
<ProductNDC>35573-420</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>35573-421-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (35573-421-30) </PackageDescription>
<NDC11Code>35573-0421-30</NDC11Code>
<ProductNDC>35573-421</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>35573-436-02</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (35573-436-02) </PackageDescription>
<NDC11Code>35573-0436-02</NDC11Code>
<ProductNDC>35573-436</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loxapine</ProprietaryName>
<NonProprietaryName>Loxapine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076868</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LOXAPINE SUCCINATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.</IndicationAndUsage>
<Description>Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake.</Description>
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<PackageDescription>100 CAPSULE in 1 BOTTLE (35573-437-02) </PackageDescription>
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<StartMarketingDate>20210501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076868</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
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<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-08</LastUpdate>
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<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.</IndicationAndUsage>
<Description>Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake.</Description>
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<NDC>
<NDCCode>35573-438-02</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (35573-438-02) </PackageDescription>
<NDC11Code>35573-0438-02</NDC11Code>
<ProductNDC>35573-438</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StartMarketingDate>20210501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076868</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LOXAPINE SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-08</LastUpdate>
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<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.</IndicationAndUsage>
<Description>Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>35573-439-02</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (35573-439-02) </PackageDescription>
<NDC11Code>35573-0439-02</NDC11Code>
<ProductNDC>35573-439</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loxapine</ProprietaryName>
<NonProprietaryName>Loxapine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076868</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LOXAPINE SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.</IndicationAndUsage>
<Description>Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>35573-464-02</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-464-02) </PackageDescription>
<NDC11Code>35573-0464-02</NDC11Code>
<ProductNDC>35573-464</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</ProprietaryName>
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<StartMarketingDate>20191216</StartMarketingDate>
<EndMarketingDate>20280229</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212037</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE</SubstanceName>
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<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
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<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191216</StartMarketingDatePackage>
<EndMarketingDatePackage>20280229</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. (1).</IndicationAndUsage>
<Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Inactive Ingredients and ColorsThe inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: ferric oxide red, ferric oxide yellow, gelatin capsules, hypromellose 2910/3 cP, 6 cP and 50 cP, methacrylic acid and ethyl acrylate copolymer, titanium dioxide, polyethylene glycol, polysorbate 80, sugar spheres, talc, and triethyl citrate. The 5 mg gelatin capsules contain gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1 and FD&C yellow #6. The 10 mg gelatin capsules contain gelatin, FD&C blue #1, and FD&C red #40. The 15 mg gelatin capsules contain gelatin, titanium dioxide, FD&C blue #1, and FD&C yellow #6. The 20 mg gelatin capsules contain gelatin, titanium dioxide, and FD&C red #3. The 25 mg gelatin capsules contain gelatin, FD&C red #40, and FD&C yellow #6. The 30 mg gelatin capsules contain gelatin, titanium dioxide, D&C red #28, and FD&C red #40. The ink ingredients are common for all strengths: the capsule imprint black ink contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>35573-465-02</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-465-02) </PackageDescription>
<NDC11Code>35573-0465-02</NDC11Code>
<ProductNDC>35573-465</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</ProprietaryName>
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<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191216</StartMarketingDate>
<EndMarketingDate>20280229</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212037</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>2.5; 2.5; 2.5; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191216</StartMarketingDatePackage>
<EndMarketingDatePackage>20280229</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. (1).</IndicationAndUsage>
<Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Inactive Ingredients and ColorsThe inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: ferric oxide red, ferric oxide yellow, gelatin capsules, hypromellose 2910/3 cP, 6 cP and 50 cP, methacrylic acid and ethyl acrylate copolymer, titanium dioxide, polyethylene glycol, polysorbate 80, sugar spheres, talc, and triethyl citrate. The 5 mg gelatin capsules contain gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1 and FD&C yellow #6. The 10 mg gelatin capsules contain gelatin, FD&C blue #1, and FD&C red #40. The 15 mg gelatin capsules contain gelatin, titanium dioxide, FD&C blue #1, and FD&C yellow #6. The 20 mg gelatin capsules contain gelatin, titanium dioxide, and FD&C red #3. The 25 mg gelatin capsules contain gelatin, FD&C red #40, and FD&C yellow #6. The 30 mg gelatin capsules contain gelatin, titanium dioxide, D&C red #28, and FD&C red #40. The ink ingredients are common for all strengths: the capsule imprint black ink contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, propylene glycol, and shellac.</Description>
</NDC>
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