{
"NDC": [
{
"NDCCode": "47781-570-89",
"PackageDescription": "5 TUBE in 1 CARTON (47781-570-89) > 5 g in 1 TUBE",
"NDC11Code": "47781-0570-89",
"ProductNDC": "47781-570",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180112",
"EndMarketingDate": "20220901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180112",
"EndMarketingDatePackage": "20220901",
"SamplePackage": "N"
},
{
"NDCCode": "74588-570-13",
"PackageDescription": "1.89 L in 1 BOTTLE (74588-570-13) ",
"NDC11Code": "74588-0570-13",
"ProductNDC": "74588-570",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hygienex Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Global Impact Innovation LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "166.4",
"StrengthUnit": "L/208L",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "47781-652-89",
"PackageDescription": "1 SYRINGE in 1 CARTON (47781-652-89) / 2.24 mL in 1 SYRINGE",
"NDC11Code": "47781-0652-89",
"ProductNDC": "47781-652",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teriparatide",
"NonProprietaryName": "Teriparatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20191114",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211939",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "TERIPARATIDE",
"StrengthNumber": "250",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]",
"Status": "Active",
"LastUpdate": "2025-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191114",
"SamplePackage": "N",
"IndicationAndUsage": "Teriparatide injection is indicated: 1 For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, teriparatide injection reduces the risk of vertebral and nonvertebral fractures., 2 To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy., 3 For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.",
"Description": "Teriparatide injection is a recombinant human parathyroid hormone analog (PTH 1-34). It has an identical sequence to the 34 N‑terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The molecular formula of teriparatide is C181H291N55O51S2 and the molecular weight is 4117.8 daltons. Its amino acid sequence is shown below:. Teriparatide is manufactured using a strain of Pseudomonas fluorescens modified by recombinant DNA technology. Teriparatide injection is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a single-patient-use delivery device (pen) for subcutaneous injection. Each pen is filled with volume to allow delivery of 2.24 mL. Each mL contains 250 mcg teriparatide (as a free base), 0.41 mg glacial acetic acid, 0.10 mg sodium acetate, 45.4 mg mannitol, 3 mg metacresol, and water for injection. The drug product is a pH 4.0 solution. Each cartridge, pre-assembled into a delivery device, delivers 20 mcg of teriparatide per dose each day for up to 28 days. Each device contains additional volume to allow troubleshooting of the device 2 times."
},
{
"NDCCode": "47781-852-89",
"PackageDescription": "1 SYRINGE in 1 CARTON (47781-852-89) / 2.24 mL in 1 SYRINGE",
"NDC11Code": "47781-0852-89",
"ProductNDC": "47781-852",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bonsity",
"NonProprietaryName": "Teriparatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250606",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211939",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "TERIPARATIDE",
"StrengthNumber": "250",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]",
"Status": "Active",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250606",
"SamplePackage": "N",
"IndicationAndUsage": "BONSITY is indicated: 1 For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, BONSITY reduces the risk of vertebral and nonvertebral fractures., 2 To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy., 3 For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.",
"Description": "BONSITY (teriparatide injection) is a recombinant human parathyroid hormone analog (PTH 1-34). It has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The molecular formula of teriparatide is C181H291N55O51S2 and the molecular weight is 4117.8 daltons. Its amino acid sequence is shown below. Teriparatide is manufactured using a strain of Pseudomonas fluorescens modified by recombinant DNA technology. BONSITY is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a single-patient-use delivery device (pen) for subcutaneous injection. Each pen is filled with volume to allow delivery of 2.24 mL. Each mL contains 250 mcg teriparatide (as a free base), 0.41 mg glacial acetic acid, 0.10 mg sodium acetate, 45.4 mg mannitol, 3 mg metacresol, and water for injection. The drug product is a pH 4.0 solution. Each cartridge, pre-assembled into a delivery device, delivers 20 mcg of teriparatide per dose each day for up to 28 days. Each device contains additional volume to allow troubleshooting of the device 2 times."
},
{
"NDCCode": "47781-570-47",
"PackageDescription": "5 TUBE in 1 CARTON (47781-570-47) > 5 g in 1 TUBE",
"NDC11Code": "47781-0570-47",
"ProductNDC": "47781-570",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180112",
"EndMarketingDate": "20220901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180219",
"EndMarketingDatePackage": "20220901",
"SamplePackage": "N"
},
{
"NDCCode": "47781-570-72",
"PackageDescription": "1 TUBE in 1 CARTON (47781-570-72) > 15 g in 1 TUBE",
"NDC11Code": "47781-0570-72",
"ProductNDC": "47781-570",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180112",
"EndMarketingDate": "20220901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180219",
"EndMarketingDatePackage": "20220901",
"SamplePackage": "N"
},
{
"NDCCode": "47781-570-73",
"PackageDescription": "1 TUBE in 1 CARTON (47781-570-73) > 30 g in 1 TUBE",
"NDC11Code": "47781-0570-73",
"ProductNDC": "47781-570",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180112",
"EndMarketingDate": "20220901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180219",
"EndMarketingDatePackage": "20220901",
"SamplePackage": "N"
},
{
"NDCCode": "58468-0050-1",
"PackageDescription": "1 VIAL in 1 CARTON (58468-0050-1) / 5.1 mL in 1 VIAL",
"NDC11Code": "58468-0050-01",
"ProductNDC": "58468-0050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xenpozyme",
"NonProprietaryName": "Olipudase Alfa-rpcp",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761261",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "OLIPUDASE ALFA",
"StrengthNumber": "20",
"StrengthUnit": "mg/5.1mL",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220829",
"SamplePackage": "N",
"IndicationAndUsage": "XENPOZYME is indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients.",
"Description": "Olipudase alfa-rpcp is a hydrolytic lysosomal sphingomyelin-specific enzyme consisting of 570 amino acids produced in a Chinese hamster ovary cell line by recombinant DNA technology. The molecular weight of olipudase alfa-rpcp is approximately 76 kDa. XENPOZYME (olipudase alfa-rpcp) for injection is supplied as a sterile, preservative-free, white to off-white lyophilized powder for reconstitution and dilution to be administered via intravenous infusion. XENPOZYME is supplied in single-dose vials. Each 4 mg vial contains 4 mg olipudase alfa-rpcp, dibasic sodium phosphate (0.89 mg), methionine (14.92 mg), monobasic sodium phosphate (1.63 mg), and sucrose (50 mg). After reconstitution with 1.1 mL of Sterile Water for Injection, USP, the final concentration is 4 mg/mL [see Dosage and Administration (2.6)]. Each 20 mg vial contains 20 mg olipudase alfa-rpcp, dibasic sodium phosphate (4.47 mg), methionine (74.6 mg), monobasic sodium phosphate (8.17 mg), and sucrose (250 mg). After reconstitution with 5.1 mL of Sterile Water for Injection, USP, the final concentration is 4 mg/mL [see Dosage and Administration (2.6)]. The pH is 6.5 after reconstitution."
},
{
"NDCCode": "58468-0051-1",
"PackageDescription": "1 VIAL in 1 CARTON (58468-0051-1) / 1.1 mL in 1 VIAL",
"NDC11Code": "58468-0051-01",
"ProductNDC": "58468-0051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xenpozyme",
"NonProprietaryName": "Olipudase Alfa-rpcp",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761261",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "OLIPUDASE ALFA",
"StrengthNumber": "4",
"StrengthUnit": "mg/1.1mL",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220829",
"SamplePackage": "N",
"IndicationAndUsage": "XENPOZYME is indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients.",
"Description": "Olipudase alfa-rpcp is a hydrolytic lysosomal sphingomyelin-specific enzyme consisting of 570 amino acids produced in a Chinese hamster ovary cell line by recombinant DNA technology. The molecular weight of olipudase alfa-rpcp is approximately 76 kDa. XENPOZYME (olipudase alfa-rpcp) for injection is supplied as a sterile, preservative-free, white to off-white lyophilized powder for reconstitution and dilution to be administered via intravenous infusion. XENPOZYME is supplied in single-dose vials. Each 4 mg vial contains 4 mg olipudase alfa-rpcp, dibasic sodium phosphate (0.89 mg), methionine (14.92 mg), monobasic sodium phosphate (1.63 mg), and sucrose (50 mg). After reconstitution with 1.1 mL of Sterile Water for Injection, USP, the final concentration is 4 mg/mL [see Dosage and Administration (2.6)]. Each 20 mg vial contains 20 mg olipudase alfa-rpcp, dibasic sodium phosphate (4.47 mg), methionine (74.6 mg), monobasic sodium phosphate (8.17 mg), and sucrose (250 mg). After reconstitution with 5.1 mL of Sterile Water for Injection, USP, the final concentration is 4 mg/mL [see Dosage and Administration (2.6)]. The pH is 6.5 after reconstitution."
},
{
"NDCCode": "0078-0698-19",
"PackageDescription": "4 CARTON in 1 CARTON (0078-0698-19) / 14 BLISTER PACK in 1 CARTON (0078-0698-51) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02) ",
"NDC11Code": "00078-0698-19",
"ProductNDC": "0078-0698",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rydapt",
"NonProprietaryName": "Rydapt",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20170428",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207997",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "MIDOSTAURIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170428",
"SamplePackage": "N",
"IndicationAndUsage": "RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: 1 Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. (1.1)Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML., 2 Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). (1.2).",
"Description": "Midostaurin is a kinase inhibitor for oral use. The molecular formula for midostaurin is C35H30N4O4. The molecular weight is 570.65 g/mol. The chemical name of midostaurin is Benzamide, N-[(9S,10R,11R,13R)-2,3,10,11,12,13-hexahydro-10-methoxy-9-methyl-1-oxo-9,13-epoxy-1H,9H-diindolo[1,2,3-gh:3′,2′,1′-lm]pyrrolo[3,4-j][1,7]benzodiazonin-11-yl]-N-methyl-. The chemical structure of midostaurin is shown below. RYDAPT is supplied as a soft capsule containing 25 mg of midostaurin. The capsule contains carmine, corn oil mono-di-triglycerides, dehydrated alcohol, ferric oxide red, ferric oxide yellow, gelatin, glycerin 85%, hypromellose 2910, polyethylene glycol 400, polyoxyl 40 hydrogenated castor oil, propylene glycol, purified water, titanium dioxide, and vitamin E."
},
{
"NDCCode": "0078-0698-99",
"PackageDescription": "2 CARTON in 1 CARTON (0078-0698-99) / 14 BLISTER PACK in 1 CARTON (0078-0698-51) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02) ",
"NDC11Code": "00078-0698-99",
"ProductNDC": "0078-0698",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rydapt",
"NonProprietaryName": "Rydapt",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20170428",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207997",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "MIDOSTAURIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170428",
"SamplePackage": "N",
"IndicationAndUsage": "RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: 1 Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. (1.1)Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML., 2 Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). (1.2).",
"Description": "Midostaurin is a kinase inhibitor for oral use. The molecular formula for midostaurin is C35H30N4O4. The molecular weight is 570.65 g/mol. The chemical name of midostaurin is Benzamide, N-[(9S,10R,11R,13R)-2,3,10,11,12,13-hexahydro-10-methoxy-9-methyl-1-oxo-9,13-epoxy-1H,9H-diindolo[1,2,3-gh:3′,2′,1′-lm]pyrrolo[3,4-j][1,7]benzodiazonin-11-yl]-N-methyl-. The chemical structure of midostaurin is shown below. RYDAPT is supplied as a soft capsule containing 25 mg of midostaurin. The capsule contains carmine, corn oil mono-di-triglycerides, dehydrated alcohol, ferric oxide red, ferric oxide yellow, gelatin, glycerin 85%, hypromellose 2910, polyethylene glycol 400, polyoxyl 40 hydrogenated castor oil, propylene glycol, purified water, titanium dioxide, and vitamin E."
},
{
"NDCCode": "0338-1083-04",
"PackageDescription": "2000 mL in 1 BAG (0338-1083-04) ",
"NDC11Code": "00338-1083-04",
"ProductNDC": "0338-1083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19970929",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020734",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE",
"StrengthNumber": "201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 5",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-11-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19970929",
"SamplePackage": "N"
},
{
"NDCCode": "0338-1107-04",
"PackageDescription": "2000 mL in 1 BAG (0338-1107-04) ",
"NDC11Code": "00338-1107-04",
"ProductNDC": "0338-1107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix E",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19970326",
"EndMarketingDate": "20190831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020678",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
"StrengthNumber": "201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 217; 261; 51; 112; 33; 5",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19970326",
"EndMarketingDatePackage": "20190831",
"SamplePackage": "N"
},
{
"NDCCode": "0338-1109-04",
"PackageDescription": "2000 mL in 1 BAG (0338-1109-04) ",
"NDC11Code": "00338-1109-04",
"ProductNDC": "0338-1109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix E",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19970326",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020678",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
"StrengthNumber": "201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 217; 261; 51; 112; 33; 10",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]",
"Status": "Deprecated",
"LastUpdate": "2018-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19970326",
"SamplePackage": "N"
},
{
"NDCCode": "0338-1132-03",
"PackageDescription": "1000 mL in 1 BAG (0338-1132-03) ",
"NDC11Code": "00338-1132-03",
"ProductNDC": "0338-1132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19970929",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020734",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE",
"StrengthNumber": "201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 5",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-11-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19970929",
"SamplePackage": "N"
},
{
"NDCCode": "0338-1142-03",
"PackageDescription": "1000 mL in 1 BAG (0338-1142-03) ",
"NDC11Code": "00338-1142-03",
"ProductNDC": "0338-1142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix E",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19970326",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020678",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
"StrengthNumber": "201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 217; 261; 51; 112; 33; 5",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19970326",
"SamplePackage": "N",
"IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
"Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-1143-03",
"PackageDescription": "1000 mL in 1 BAG (0338-1143-03) ",
"NDC11Code": "00338-1143-03",
"ProductNDC": "0338-1143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix E",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19970326",
"EndMarketingDate": "20190831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020678",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
"StrengthNumber": "201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 217; 261; 51; 112; 33; 10",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19970326",
"EndMarketingDatePackage": "20190831",
"SamplePackage": "N"
},
{
"NDCCode": "0338-7020-06",
"PackageDescription": "6 BAG in 1 CARTON (0338-7020-06) / 1000 mL in 1 BAG (0338-7020-01) ",
"NDC11Code": "00338-7020-06",
"ProductNDC": "0338-7020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix E",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020678",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
"StrengthNumber": "201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 216; 261; 51; 112; 33; 5",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240715",
"SamplePackage": "N",
"IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
"Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0409-4178-03",
"PackageDescription": "12 BAG in 1 CASE (0409-4178-03) > 500 mL in 1 BAG",
"NDC11Code": "00409-4178-03",
"ProductNDC": "0409-4178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn-pf",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19850906",
"EndMarketingDate": "20231201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019398",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
"StrengthNumber": "490; 861; 370; 576; 270; 220; 534; 831; 475; 125; 300; 570; 347; 50; 360; 125; 44; 452",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19850906",
"EndMarketingDatePackage": "20231201",
"SamplePackage": "N"
},
{
"NDCCode": "0990-4178-03",
"PackageDescription": "12 BAG in 1 CASE (0990-4178-03) / 500 mL in 1 BAG",
"NDC11Code": "00990-4178-03",
"ProductNDC": "0990-4178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn-pf",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019398",
"LabelerName": "ICU Medical Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; PROLINE; SERINE; TAURINE; TYROSINE",
"StrengthNumber": "534; 831; 475; 125; 300; 360; 125; 452; 490; 861; 370; 576; 270; 220; 570; 347; 50; 44",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211001",
"SamplePackage": "N",
"IndicationAndUsage": "Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with Aminosyn-PF 7% is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where (1) the alimentary tract by the oral gastrostomy, or jejunostomy route, cannot or should not be used or adequate protein intake is not feasible by these routes, (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutrition support, and vein tolerance. See DOSAGE AND ADMINISTRATION for additional information. Central Venous Infusion. Central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted infants or those requiring long-term parenteral nutrition. Peripheral Parenteral Nutrition. For moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions mixed with 5 to 10% dextrose solutions may be infused by peripheral vein, supplemented, if desired, with fat emulsion.",
"Description": "Aminosyn®-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn®-PF 7% is oxygen sensitive. The formulation is described below. * Amount cited is for lysine alone and does not include the acetate salt. a From lysine acetate. The formulas for the individual amino acids present in Aminosyn-PF 7% are as follows. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
},
{
"NDCCode": "10356-570-05",
"PackageDescription": "50 mL in 1 BOTTLE, PUMP (10356-570-05)",
"NDC11Code": "10356-0570-05",
"ProductNDC": "10356-570",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nivea For Men Q10 Energy",
"NonProprietaryName": "Avobenzone, Octinoxate, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120515",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Beiersdorf Inc",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OXYBENZONE",
"StrengthNumber": "2; 6; 2",
"StrengthUnit": "mL/100mL; mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2016-03-11"
},
{
"NDCCode": "10482-001-09",
"PackageDescription": "570 L in 1 CYLINDER (10482-001-09) ",
"NDC11Code": "10482-0001-09",
"ProductNDC": "10482-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19750101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205865",
"LabelerName": "R. N. Goss Gas Products Company",
"SubstanceName": "OXYGEN",
"StrengthNumber": "995",
"StrengthUnit": "L/L",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19750101",
"SamplePackage": "N"
},
{
"NDCCode": "10482-002-09",
"PackageDescription": "570 L in 1 CYLINDER (10482-002-09) ",
"NDC11Code": "10482-0002-09",
"ProductNDC": "10482-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19750101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205865",
"LabelerName": "R. N. Goss Gas Products Company",
"SubstanceName": "OXYGEN",
"StrengthNumber": "995",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19750101",
"SamplePackage": "N"
},
{
"NDCCode": "10544-570-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10544-570-30)",
"NDC11Code": "10544-0570-30",
"ProductNDC": "10544-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070994",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "P-Glycoprotein Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Verapamil Hydrochloride Tablets are indicated for the treatment of the following. Angina 1. Angina at rest including: – Vasospastic (Prinzmetal’s variant) angina – Unstable (crescendo, pre-infarction) angina 2. Chronic stable angina (classic effort-associated angina). Arrhythmias 1. In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS; Accessory bypass tract) 2. Prophylaxis of repetitive paroxysmal supraventricular tachycardia. Essential hypertension: Verapamil is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.",
"Description": "Verapamil hydrochloride is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) available for oral administration in film-coated tablets containing 40 mg, 80 mg, or 120 mg of verapamil hydrochloride. The structural formula of verapamil hydrochloride is. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil hydrochloride is not chemically related to other cardioactive drugs. Inactive ingredients include anhydrous lactose, corn starch, hypromellose 2910, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and polyethylene glycol 400. In addition the following coloring agents are used: FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose and titanium dioxide (40 mg light peach); hydroxypropyl cellulose and titanium dioxide (80 mg white and 120 mg white)."
},
{
"NDCCode": "10641-001-08",
"PackageDescription": "570 L in 1 CYLINDER (10641-001-08)",
"NDC11Code": "10641-0001-08",
"ProductNDC": "10641-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19530908",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Lake Welding Supply Company",
"SubstanceName": "OXYGEN",
"StrengthNumber": "995",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10825-001-04",
"PackageDescription": "570 L in 1 CYLINDER (10825-001-04)",
"NDC11Code": "10825-0001-04",
"ProductNDC": "10825-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19740101",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Northern Welding Supply",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "11344-570-16",
"PackageDescription": "59 mL in 1 BOTTLE, PLASTIC (11344-570-16) ",
"NDC11Code": "11344-0570-16",
"ProductNDC": "11344-570",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151122",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Vi-Jon, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-02-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20151122",
"SamplePackage": "N",
"IndicationAndUsage": "to decrease bacteria on the skin that could cause disease. recommend for repeated use."
},
{
"NDCCode": "11344-570-34",
"PackageDescription": "236 mL in 1 BOTTLE, PUMP (11344-570-34) ",
"NDC11Code": "11344-0570-34",
"ProductNDC": "11344-570",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151122",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Vi-Jon, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-02-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20151122",
"SamplePackage": "N",
"IndicationAndUsage": "to decrease bacteria on the skin that could cause disease. recommend for repeated use."
},
{
"NDCCode": "13537-570-01",
"PackageDescription": "1 CONTAINER in 1 BOX (13537-570-01) > 11 g in 1 CONTAINER",
"NDC11Code": "13537-0570-01",
"ProductNDC": "13537-570",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Dual-use Compact Youthful Looking Skin Spf7",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130916",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": ".05",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides minimal protection against sunburn."
},
{
"NDCCode": "14290-570-93",
"PackageDescription": "1 BOTTLE in 1 CARTON (14290-570-93) > 5 CAPSULE, COATED PELLETS in 1 BOTTLE",
"NDC11Code": "14290-0570-93",
"ProductNDC": "14290-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocin Kit",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20070901",
"EndMarketingDate": "20160131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050649",
"LabelerName": "Triax Pharmaceuticals, LLC",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-02-05"
}
]
}
{"NDC":[{"NDCCode":"47781-570-89","ProprietaryName":"Lidocaine","NonProprietaryName":"Lidocaine"},{"NDCCode":"74588-570-13","ProprietaryName":"Hygienex Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"47781-652-89","ProprietaryName":"Teriparatide","NonProprietaryName":"Teriparatide"},{"NDCCode":"47781-852-89","ProprietaryName":"Bonsity","NonProprietaryName":"Teriparatide"},{"NDCCode":"47781-570-47","ProprietaryName":"Lidocaine","NonProprietaryName":"Lidocaine"},{"NDCCode":"47781-570-72","ProprietaryName":"Lidocaine","NonProprietaryName":"Lidocaine"},{"NDCCode":"47781-570-73","ProprietaryName":"Lidocaine","NonProprietaryName":"Lidocaine"},{"NDCCode":"58468-0050-1","ProprietaryName":"Xenpozyme","NonProprietaryName":"Olipudase Alfa-rpcp"},{"NDCCode":"58468-0051-1","ProprietaryName":"Xenpozyme","NonProprietaryName":"Olipudase Alfa-rpcp"},{"NDCCode":"0078-0698-19","ProprietaryName":"Rydapt","NonProprietaryName":"Rydapt"},{"NDCCode":"0078-0698-99","ProprietaryName":"Rydapt","NonProprietaryName":"Rydapt"},{"NDCCode":"0338-1083-04","ProprietaryName":"Clinimix","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose"},{"NDCCode":"0338-1107-04","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0338-1109-04","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0338-1132-03","ProprietaryName":"Clinimix","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose"},{"NDCCode":"0338-1142-03","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0338-1143-03","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0338-7020-06","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0409-4178-03","ProprietaryName":"Aminosyn-pf","NonProprietaryName":"Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine"},{"NDCCode":"0990-4178-03","ProprietaryName":"Aminosyn-pf","NonProprietaryName":"Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine"},{"NDCCode":"10356-570-05","ProprietaryName":"Nivea For Men Q10 Energy","NonProprietaryName":"Avobenzone, Octinoxate, Oxybenzone"},{"NDCCode":"10482-001-09","ProprietaryName":"Oxygen","NonProprietaryName":"Oxygen"},{"NDCCode":"10482-002-09","ProprietaryName":"Oxygen","NonProprietaryName":"Oxygen"},{"NDCCode":"10544-570-30","ProprietaryName":"Verapamil Hydrochloride","NonProprietaryName":"Verapamil Hydrochloride"},{"NDCCode":"10641-001-08","ProprietaryName":"Oxygen","NonProprietaryName":"Oxygen"},{"NDCCode":"10825-001-04","ProprietaryName":"Oxygen","NonProprietaryName":"Oxygen"},{"NDCCode":"11344-570-16","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"11344-570-34","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"13537-570-01","ProprietaryName":"Lbel Effet Parfait Dual-use Compact Youthful Looking Skin Spf7","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"14290-570-93","ProprietaryName":"Minocin Kit","NonProprietaryName":"Minocycline Hydrochloride"}]}
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<NDCList>
<NDC>
<NDCCode>47781-570-89</NDCCode>
<PackageDescription>5 TUBE in 1 CARTON (47781-570-89) > 5 g in 1 TUBE</PackageDescription>
<NDC11Code>47781-0570-89</NDC11Code>
<ProductNDC>47781-570</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180112</StartMarketingDate>
<EndMarketingDate>20220901</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180112</StartMarketingDatePackage>
<EndMarketingDatePackage>20220901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>74588-570-13</NDCCode>
<PackageDescription>1.89 L in 1 BOTTLE (74588-570-13) </PackageDescription>
<NDC11Code>74588-0570-13</NDC11Code>
<ProductNDC>74588-570</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hygienex Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Global Impact Innovation LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>166.4</StrengthNumber>
<StrengthUnit>L/208L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>47781-652-89</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (47781-652-89) / 2.24 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>47781-0652-89</NDC11Code>
<ProductNDC>47781-652</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teriparatide</ProprietaryName>
<NonProprietaryName>Teriparatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20191114</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211939</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>TERIPARATIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teriparatide injection is indicated: 1 For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, teriparatide injection reduces the risk of vertebral and nonvertebral fractures., 2 To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy., 3 For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.</IndicationAndUsage>
<Description>Teriparatide injection is a recombinant human parathyroid hormone analog (PTH 1-34). It has an identical sequence to the 34 N‑terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The molecular formula of teriparatide is C181H291N55O51S2 and the molecular weight is 4117.8 daltons. Its amino acid sequence is shown below:. Teriparatide is manufactured using a strain of Pseudomonas fluorescens modified by recombinant DNA technology. Teriparatide injection is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a single-patient-use delivery device (pen) for subcutaneous injection. Each pen is filled with volume to allow delivery of 2.24 mL. Each mL contains 250 mcg teriparatide (as a free base), 0.41 mg glacial acetic acid, 0.10 mg sodium acetate, 45.4 mg mannitol, 3 mg metacresol, and water for injection. The drug product is a pH 4.0 solution. Each cartridge, pre-assembled into a delivery device, delivers 20 mcg of teriparatide per dose each day for up to 28 days. Each device contains additional volume to allow troubleshooting of the device 2 times.</Description>
</NDC>
<NDC>
<NDCCode>47781-852-89</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (47781-852-89) / 2.24 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>47781-0852-89</NDC11Code>
<ProductNDC>47781-852</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bonsity</ProprietaryName>
<NonProprietaryName>Teriparatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250606</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211939</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>TERIPARATIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BONSITY is indicated: 1 For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, BONSITY reduces the risk of vertebral and nonvertebral fractures., 2 To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy., 3 For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.</IndicationAndUsage>
<Description>BONSITY (teriparatide injection) is a recombinant human parathyroid hormone analog (PTH 1-34). It has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The molecular formula of teriparatide is C181H291N55O51S2 and the molecular weight is 4117.8 daltons. Its amino acid sequence is shown below. Teriparatide is manufactured using a strain of Pseudomonas fluorescens modified by recombinant DNA technology. BONSITY is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a single-patient-use delivery device (pen) for subcutaneous injection. Each pen is filled with volume to allow delivery of 2.24 mL. Each mL contains 250 mcg teriparatide (as a free base), 0.41 mg glacial acetic acid, 0.10 mg sodium acetate, 45.4 mg mannitol, 3 mg metacresol, and water for injection. The drug product is a pH 4.0 solution. Each cartridge, pre-assembled into a delivery device, delivers 20 mcg of teriparatide per dose each day for up to 28 days. Each device contains additional volume to allow troubleshooting of the device 2 times.</Description>
</NDC>
<NDC>
<NDCCode>47781-570-47</NDCCode>
<PackageDescription>5 TUBE in 1 CARTON (47781-570-47) > 5 g in 1 TUBE</PackageDescription>
<NDC11Code>47781-0570-47</NDC11Code>
<ProductNDC>47781-570</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180112</StartMarketingDate>
<EndMarketingDate>20220901</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180219</StartMarketingDatePackage>
<EndMarketingDatePackage>20220901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>47781-570-72</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (47781-570-72) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>47781-0570-72</NDC11Code>
<ProductNDC>47781-570</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180112</StartMarketingDate>
<EndMarketingDate>20220901</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180219</StartMarketingDatePackage>
<EndMarketingDatePackage>20220901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>47781-570-73</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (47781-570-73) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>47781-0570-73</NDC11Code>
<ProductNDC>47781-570</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180112</StartMarketingDate>
<EndMarketingDate>20220901</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180219</StartMarketingDatePackage>
<EndMarketingDatePackage>20220901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58468-0050-1</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (58468-0050-1) / 5.1 mL in 1 VIAL</PackageDescription>
<NDC11Code>58468-0050-01</NDC11Code>
<ProductNDC>58468-0050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xenpozyme</ProprietaryName>
<NonProprietaryName>Olipudase Alfa-rpcp</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761261</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>OLIPUDASE ALFA</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/5.1mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XENPOZYME is indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients.</IndicationAndUsage>
<Description>Olipudase alfa-rpcp is a hydrolytic lysosomal sphingomyelin-specific enzyme consisting of 570 amino acids produced in a Chinese hamster ovary cell line by recombinant DNA technology. The molecular weight of olipudase alfa-rpcp is approximately 76 kDa. XENPOZYME (olipudase alfa-rpcp) for injection is supplied as a sterile, preservative-free, white to off-white lyophilized powder for reconstitution and dilution to be administered via intravenous infusion. XENPOZYME is supplied in single-dose vials. Each 4 mg vial contains 4 mg olipudase alfa-rpcp, dibasic sodium phosphate (0.89 mg), methionine (14.92 mg), monobasic sodium phosphate (1.63 mg), and sucrose (50 mg). After reconstitution with 1.1 mL of Sterile Water for Injection, USP, the final concentration is 4 mg/mL [see Dosage and Administration (2.6)]. Each 20 mg vial contains 20 mg olipudase alfa-rpcp, dibasic sodium phosphate (4.47 mg), methionine (74.6 mg), monobasic sodium phosphate (8.17 mg), and sucrose (250 mg). After reconstitution with 5.1 mL of Sterile Water for Injection, USP, the final concentration is 4 mg/mL [see Dosage and Administration (2.6)]. The pH is 6.5 after reconstitution.</Description>
</NDC>
<NDC>
<NDCCode>58468-0051-1</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (58468-0051-1) / 1.1 mL in 1 VIAL</PackageDescription>
<NDC11Code>58468-0051-01</NDC11Code>
<ProductNDC>58468-0051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xenpozyme</ProprietaryName>
<NonProprietaryName>Olipudase Alfa-rpcp</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761261</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>OLIPUDASE ALFA</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1.1mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XENPOZYME is indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients.</IndicationAndUsage>
<Description>Olipudase alfa-rpcp is a hydrolytic lysosomal sphingomyelin-specific enzyme consisting of 570 amino acids produced in a Chinese hamster ovary cell line by recombinant DNA technology. The molecular weight of olipudase alfa-rpcp is approximately 76 kDa. XENPOZYME (olipudase alfa-rpcp) for injection is supplied as a sterile, preservative-free, white to off-white lyophilized powder for reconstitution and dilution to be administered via intravenous infusion. XENPOZYME is supplied in single-dose vials. Each 4 mg vial contains 4 mg olipudase alfa-rpcp, dibasic sodium phosphate (0.89 mg), methionine (14.92 mg), monobasic sodium phosphate (1.63 mg), and sucrose (50 mg). After reconstitution with 1.1 mL of Sterile Water for Injection, USP, the final concentration is 4 mg/mL [see Dosage and Administration (2.6)]. Each 20 mg vial contains 20 mg olipudase alfa-rpcp, dibasic sodium phosphate (4.47 mg), methionine (74.6 mg), monobasic sodium phosphate (8.17 mg), and sucrose (250 mg). After reconstitution with 5.1 mL of Sterile Water for Injection, USP, the final concentration is 4 mg/mL [see Dosage and Administration (2.6)]. The pH is 6.5 after reconstitution.</Description>
</NDC>
<NDC>
<NDCCode>0078-0698-19</NDCCode>
<PackageDescription>4 CARTON in 1 CARTON (0078-0698-19) / 14 BLISTER PACK in 1 CARTON (0078-0698-51) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02) </PackageDescription>
<NDC11Code>00078-0698-19</NDC11Code>
<ProductNDC>0078-0698</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rydapt</ProprietaryName>
<NonProprietaryName>Rydapt</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170428</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207997</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>MIDOSTAURIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: 1 Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. (1.1)Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML., 2 Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). (1.2).</IndicationAndUsage>
<Description>Midostaurin is a kinase inhibitor for oral use. The molecular formula for midostaurin is C35H30N4O4. The molecular weight is 570.65 g/mol. The chemical name of midostaurin is Benzamide, N-[(9S,10R,11R,13R)-2,3,10,11,12,13-hexahydro-10-methoxy-9-methyl-1-oxo-9,13-epoxy-1H,9H-diindolo[1,2,3-gh:3′,2′,1′-lm]pyrrolo[3,4-j][1,7]benzodiazonin-11-yl]-N-methyl-. The chemical structure of midostaurin is shown below. RYDAPT is supplied as a soft capsule containing 25 mg of midostaurin. The capsule contains carmine, corn oil mono-di-triglycerides, dehydrated alcohol, ferric oxide red, ferric oxide yellow, gelatin, glycerin 85%, hypromellose 2910, polyethylene glycol 400, polyoxyl 40 hydrogenated castor oil, propylene glycol, purified water, titanium dioxide, and vitamin E.</Description>
</NDC>
<NDC>
<NDCCode>0078-0698-99</NDCCode>
<PackageDescription>2 CARTON in 1 CARTON (0078-0698-99) / 14 BLISTER PACK in 1 CARTON (0078-0698-51) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02) </PackageDescription>
<NDC11Code>00078-0698-99</NDC11Code>
<ProductNDC>0078-0698</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rydapt</ProprietaryName>
<NonProprietaryName>Rydapt</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170428</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207997</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>MIDOSTAURIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: 1 Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. (1.1)Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML., 2 Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). (1.2).</IndicationAndUsage>
<Description>Midostaurin is a kinase inhibitor for oral use. The molecular formula for midostaurin is C35H30N4O4. The molecular weight is 570.65 g/mol. The chemical name of midostaurin is Benzamide, N-[(9S,10R,11R,13R)-2,3,10,11,12,13-hexahydro-10-methoxy-9-methyl-1-oxo-9,13-epoxy-1H,9H-diindolo[1,2,3-gh:3′,2′,1′-lm]pyrrolo[3,4-j][1,7]benzodiazonin-11-yl]-N-methyl-. The chemical structure of midostaurin is shown below. RYDAPT is supplied as a soft capsule containing 25 mg of midostaurin. The capsule contains carmine, corn oil mono-di-triglycerides, dehydrated alcohol, ferric oxide red, ferric oxide yellow, gelatin, glycerin 85%, hypromellose 2910, polyethylene glycol 400, polyoxyl 40 hydrogenated castor oil, propylene glycol, purified water, titanium dioxide, and vitamin E.</Description>
</NDC>
<NDC>
<NDCCode>0338-1083-04</NDCCode>
<PackageDescription>2000 mL in 1 BAG (0338-1083-04) </PackageDescription>
<NDC11Code>00338-1083-04</NDC11Code>
<ProductNDC>0338-1083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970929</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020734</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE</SubstanceName>
<StrengthNumber>201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 5</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0338-1107-04</NDCCode>
<PackageDescription>2000 mL in 1 BAG (0338-1107-04) </PackageDescription>
<NDC11Code>00338-1107-04</NDC11Code>
<ProductNDC>0338-1107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix E</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970326</StartMarketingDate>
<EndMarketingDate>20190831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020678</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE</SubstanceName>
<StrengthNumber>201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 217; 261; 51; 112; 33; 5</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19970326</StartMarketingDatePackage>
<EndMarketingDatePackage>20190831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0338-1109-04</NDCCode>
<PackageDescription>2000 mL in 1 BAG (0338-1109-04) </PackageDescription>
<NDC11Code>00338-1109-04</NDC11Code>
<ProductNDC>0338-1109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix E</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970326</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020678</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE</SubstanceName>
<StrengthNumber>201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 217; 261; 51; 112; 33; 10</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0338-1132-03</NDCCode>
<PackageDescription>1000 mL in 1 BAG (0338-1132-03) </PackageDescription>
<NDC11Code>00338-1132-03</NDC11Code>
<ProductNDC>0338-1132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970929</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020734</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE</SubstanceName>
<StrengthNumber>201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 5</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0338-1142-03</NDCCode>
<PackageDescription>1000 mL in 1 BAG (0338-1142-03) </PackageDescription>
<NDC11Code>00338-1142-03</NDC11Code>
<ProductNDC>0338-1142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix E</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970326</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020678</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE</SubstanceName>
<StrengthNumber>201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 217; 261; 51; 112; 33; 5</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-1143-03</NDCCode>
<PackageDescription>1000 mL in 1 BAG (0338-1143-03) </PackageDescription>
<NDC11Code>00338-1143-03</NDC11Code>
<ProductNDC>0338-1143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix E</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970326</StartMarketingDate>
<EndMarketingDate>20190831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020678</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE</SubstanceName>
<StrengthNumber>201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 217; 261; 51; 112; 33; 10</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19970326</StartMarketingDatePackage>
<EndMarketingDatePackage>20190831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0338-7020-06</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (0338-7020-06) / 1000 mL in 1 BAG (0338-7020-01) </PackageDescription>
<NDC11Code>00338-7020-06</NDC11Code>
<ProductNDC>0338-7020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix E</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020678</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE</SubstanceName>
<StrengthNumber>201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 216; 261; 51; 112; 33; 5</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0409-4178-03</NDCCode>
<PackageDescription>12 BAG in 1 CASE (0409-4178-03) > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4178-03</NDC11Code>
<ProductNDC>0409-4178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn-pf</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19850906</StartMarketingDate>
<EndMarketingDate>20231201</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019398</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE</SubstanceName>
<StrengthNumber>490; 861; 370; 576; 270; 220; 534; 831; 475; 125; 300; 570; 347; 50; 360; 125; 44; 452</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19850906</StartMarketingDatePackage>
<EndMarketingDatePackage>20231201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0990-4178-03</NDCCode>
<PackageDescription>12 BAG in 1 CASE (0990-4178-03) / 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-4178-03</NDC11Code>
<ProductNDC>0990-4178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn-pf</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019398</ApplicationNumber>
<LabelerName>ICU Medical Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; PROLINE; SERINE; TAURINE; TYROSINE</SubstanceName>
<StrengthNumber>534; 831; 475; 125; 300; 360; 125; 452; 490; 861; 370; 576; 270; 220; 570; 347; 50; 44</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with Aminosyn-PF 7% is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where (1) the alimentary tract by the oral gastrostomy, or jejunostomy route, cannot or should not be used or adequate protein intake is not feasible by these routes, (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutrition support, and vein tolerance. See DOSAGE AND ADMINISTRATION for additional information. Central Venous Infusion. Central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted infants or those requiring long-term parenteral nutrition. Peripheral Parenteral Nutrition. For moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions mixed with 5 to 10% dextrose solutions may be infused by peripheral vein, supplemented, if desired, with fat emulsion.</IndicationAndUsage>
<Description>Aminosyn®-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn®-PF 7% is oxygen sensitive. The formulation is described below. * Amount cited is for lysine alone and does not include the acetate salt. a From lysine acetate. The formulas for the individual amino acids present in Aminosyn-PF 7% are as follows. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
</NDC>
<NDC>
<NDCCode>10356-570-05</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, PUMP (10356-570-05)</PackageDescription>
<NDC11Code>10356-0570-05</NDC11Code>
<ProductNDC>10356-570</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nivea For Men Q10 Energy</ProprietaryName>
<NonProprietaryName>Avobenzone, Octinoxate, Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Beiersdorf Inc</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>2; 6; 2</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-03-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>10482-001-09</NDCCode>
<PackageDescription>570 L in 1 CYLINDER (10482-001-09) </PackageDescription>
<NDC11Code>10482-0001-09</NDC11Code>
<ProductNDC>10482-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19750101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205865</ApplicationNumber>
<LabelerName>R. N. Goss Gas Products Company</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>995</StrengthNumber>
<StrengthUnit>L/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10482-002-09</NDCCode>
<PackageDescription>570 L in 1 CYLINDER (10482-002-09) </PackageDescription>
<NDC11Code>10482-0002-09</NDC11Code>
<ProductNDC>10482-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19750101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205865</ApplicationNumber>
<LabelerName>R. N. Goss Gas Products Company</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>995</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10544-570-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10544-570-30)</PackageDescription>
<NDC11Code>10544-0570-30</NDC11Code>
<ProductNDC>10544-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070994</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>P-Glycoprotein Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Verapamil Hydrochloride Tablets are indicated for the treatment of the following. Angina 1. Angina at rest including: – Vasospastic (Prinzmetal’s variant) angina – Unstable (crescendo, pre-infarction) angina 2. Chronic stable angina (classic effort-associated angina). Arrhythmias 1. In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS; Accessory bypass tract) 2. Prophylaxis of repetitive paroxysmal supraventricular tachycardia. Essential hypertension: Verapamil is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
<Description>Verapamil hydrochloride is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) available for oral administration in film-coated tablets containing 40 mg, 80 mg, or 120 mg of verapamil hydrochloride. The structural formula of verapamil hydrochloride is. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil hydrochloride is not chemically related to other cardioactive drugs. Inactive ingredients include anhydrous lactose, corn starch, hypromellose 2910, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and polyethylene glycol 400. In addition the following coloring agents are used: FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose and titanium dioxide (40 mg light peach); hydroxypropyl cellulose and titanium dioxide (80 mg white and 120 mg white).</Description>
</NDC>
<NDC>
<NDCCode>10641-001-08</NDCCode>
<PackageDescription>570 L in 1 CYLINDER (10641-001-08)</PackageDescription>
<NDC11Code>10641-0001-08</NDC11Code>
<ProductNDC>10641-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19530908</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Lake Welding Supply Company</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>995</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10825-001-04</NDCCode>
<PackageDescription>570 L in 1 CYLINDER (10825-001-04)</PackageDescription>
<NDC11Code>10825-0001-04</NDC11Code>
<ProductNDC>10825-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19740101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Northern Welding Supply</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11344-570-16</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, PLASTIC (11344-570-16) </PackageDescription>
<NDC11Code>11344-0570-16</NDC11Code>
<ProductNDC>11344-570</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151122</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to decrease bacteria on the skin that could cause disease. recommend for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11344-570-34</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, PUMP (11344-570-34) </PackageDescription>
<NDC11Code>11344-0570-34</NDC11Code>
<ProductNDC>11344-570</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151122</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to decrease bacteria on the skin that could cause disease. recommend for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13537-570-01</NDCCode>
<PackageDescription>1 CONTAINER in 1 BOX (13537-570-01) > 11 g in 1 CONTAINER</PackageDescription>
<NDC11Code>13537-0570-01</NDC11Code>
<ProductNDC>13537-570</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait Dual-use Compact Youthful Looking Skin Spf7</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130916</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides minimal protection against sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14290-570-93</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (14290-570-93) > 5 CAPSULE, COATED PELLETS in 1 BOTTLE</PackageDescription>
<NDC11Code>14290-0570-93</NDC11Code>
<ProductNDC>14290-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocin Kit</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070901</StartMarketingDate>
<EndMarketingDate>20160131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050649</ApplicationNumber>
<LabelerName>Triax Pharmaceuticals, LLC</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-02-05</LastUpdate>
</NDC>
</NDCList>