{
"NDC": [
{
"NDCCode": "64538-780-79",
"PackageDescription": "1 mg in 1 SYRINGE, GLASS (64538-780-79) ",
"NDC11Code": "64538-0780-79",
"ProductNDC": "64538-780",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bimzelx",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20231017",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Rentschler Biopharma SE",
"SubstanceName": "BIMEKIZUMAB",
"StrengthNumber": "160",
"StrengthUnit": "mg/160mg",
"Status": "Unfinished",
"LastUpdate": "2025-01-23",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "17-OCT-23"
},
{
"NDCCode": "50474-780-79",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (50474-780-79) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "50474-0780-79",
"ProductNDC": "50474-780",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bimzelx",
"NonProprietaryName": "Bimekizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20231017",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761151",
"LabelerName": "UCB, Inc.",
"SubstanceName": "BIMEKIZUMAB",
"StrengthNumber": "160",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231017",
"SamplePackage": "N",
"IndicationAndUsage": "BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .",
"Description": "Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1."
},
{
"NDCCode": "64538-001-00",
"PackageDescription": "5 mL in 1 VIAL (64538-001-00) ",
"NDC11Code": "64538-0001-00",
"ProductNDC": "64538-001",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mepsevii",
"DosageFormName": "INJECTION",
"StartMarketingDate": "20171115",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Rentschler Biopharma SE",
"SubstanceName": "VESTRONIDASE ALFA",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2025-01-23",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "15-NOV-17"
},
{
"NDCCode": "64538-002-00",
"PackageDescription": "4 mg in 1 VIAL, SINGLE-DOSE (64538-002-00) ",
"NDC11Code": "64538-0002-00",
"ProductNDC": "64538-002",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Epcoritamab-bysp",
"DosageFormName": "INJECTION",
"StartMarketingDate": "20230519",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Rentschler Biopharma SE",
"SubstanceName": "EPCORITAMAB",
"StrengthNumber": "4",
"StrengthUnit": "mg/4mg",
"Status": "Unfinished",
"LastUpdate": "2024-10-15",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19-MAY-23"
},
{
"NDCCode": "64538-100-00",
"PackageDescription": "1.8 mL in 1 VIAL, GLASS (64538-100-00) ",
"NDC11Code": "64538-0100-00",
"ProductNDC": "64538-100",
"ProductTypeName": "VACCINE",
"NonProprietaryName": "Bnt162b2",
"DosageFormName": "INJECTION, SUSPENSION",
"StartMarketingDate": "20201212",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Rentschler Biopharma SE",
"SubstanceName": "BNT162B2",
"StrengthNumber": ".23",
"StrengthUnit": "mg/1.8mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "12-DEC-20"
},
{
"NDCCode": "64538-141-00",
"PackageDescription": "1 mg in 1 VIAL (64538-141-00)",
"NDC11Code": "64538-0141-00",
"ProductNDC": "64538-141",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate",
"DosageFormName": "POWDER, FOR SOLUTION",
"StartMarketingDate": "20110822",
"EndMarketingDate": "20130924",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Rentschler Biotechnologie GmbH",
"SubstanceName": "TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130924"
},
{
"NDCCode": "64538-180-00",
"PackageDescription": "10 mg in 1 VIAL, SINGLE-DOSE (64538-180-00) ",
"NDC11Code": "64538-0180-00",
"ProductNDC": "64538-180",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Velmanase Alfa-tycv",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"StartMarketingDate": "20230301",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Rentschler Biopharma SE",
"SubstanceName": "VELMANASE ALFA-TYCV",
"StrengthNumber": "10",
"StrengthUnit": "mg/10mg",
"Status": "Unfinished",
"LastUpdate": "2025-01-23",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-MAR-23"
},
{
"NDCCode": "64538-282-02",
"PackageDescription": "1 mg in 1 VIAL, GLASS (64538-282-02) ",
"NDC11Code": "64538-0282-02",
"ProductNDC": "64538-282",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Pivekimab Sunirine-pvzy",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"StartMarketingDate": "20260527",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Rentschler Biopharma SE",
"SubstanceName": "PIVEKIMAB SUNIRINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/2mg",
"Status": "Unfinished",
"LastUpdate": "2026-06-30",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "27-MAY-26"
},
{
"NDCCode": "64538-500-00",
"PackageDescription": "1 mL in 1 VIAL (64538-500-00) ",
"NDC11Code": "64538-0500-00",
"ProductNDC": "64538-500",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Antihemophilic Factor (recombinant), Porcine Sequence",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20141023",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Rentschler Biopharma SE",
"SubstanceName": "SUSOCTOCOG ALFA",
"StrengthNumber": "500",
"StrengthUnit": "[USP'U]/mL",
"Status": "Unfinished",
"LastUpdate": "2024-11-19",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "23-OCT-14"
},
{
"NDCCode": "64538-644-00",
"PackageDescription": "5 mL in 1 VIAL, GLASS (64538-644-00) ",
"NDC11Code": "64538-0644-00",
"ProductNDC": "64538-644",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Lanadelumab-flyo",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20180824",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Rentschler Biopharma SE",
"SubstanceName": "LANADELUMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/2mL",
"Status": "Unfinished",
"LastUpdate": "2025-01-23",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "24-AUG-18"
},
{
"NDCCode": "64538-702-00",
"PackageDescription": "30 mg in 1 SYRINGE, GLASS (64538-702-00)",
"NDC11Code": "64538-0702-00",
"ProductNDC": "64538-702",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Icatibant Acetate",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20110825",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Rentschler Biopharma SE",
"SubstanceName": "ICATIBANT ACETATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1000mg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "64538-824-00",
"PackageDescription": "130 mg in 1 SYRINGE (64538-824-00) ",
"NDC11Code": "64538-0824-00",
"ProductNDC": "64538-824",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ustekinumab-aauz",
"DosageFormName": "INJECTION",
"StartMarketingDate": "20240222",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Rentschler Biopharma SE",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "130",
"StrengthUnit": "mg/130mg",
"Status": "Unfinished",
"LastUpdate": "2025-01-23",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "22-FEB-24"
},
{
"NDCCode": "0054-0057-46",
"PackageDescription": "60 mL in 1 BOTTLE (0054-0057-46) ",
"NDC11Code": "00054-0057-46",
"ProductNDC": "0054-0057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20040826",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021648",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DIGOXIN",
"StrengthNumber": ".05",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2025-04-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040826",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin is a cardiac glycoside indicated in adults for the treatment of mild to moderate heart failure and for the control of resting ventricular rate in patients with chronic atrial fibrillation. (1.1, 1.3) In pediatric patients with heart failure, digoxin is indicated to increase myocardial contractility. (1.2).",
"Description": "Digoxin is one of the cardiac glycosides, a closely-related group of plant-derived drugs with shared pharmacological effects. The term \"digitalis\" is used to designate the whole group. Digoxin is extracted from the leaves of the common foxglove, Digitalis lanata. Like each of the other cardiac glycosides, digoxin consists of a polycyclic core and a sugar side chain. Digoxin’s chemical name is 3β-[O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide; its structural formula is. Its molecular formula is C41H64O14, and its molecular weight is 780.94. Digoxin is practically insoluble in water and in ether, slightly soluble in 50% ethanol and in chloroform, and freely soluble in pyridine. Digoxin, USP is a white or almost white powder, or colorless crystals. Digoxin Oral Solution, USP is formulated for oral administration. Each mL contains 50 mcg digoxin. The lime-flavored solution contains the following inactive ingredients: alcohol 10% (by volume at 60°F), glycerin, lime (imitation), methylparaben 0.1%, propylparaben 0.02%, purified water, sodium citrate and sorbitol solution."
},
{
"NDCCode": "0115-9811-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0115-9811-01) ",
"NDC11Code": "00115-9811-01",
"ProductNDC": "0115-9811",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078556",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "125",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090720",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin, USP is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin, USP is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin, USP is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin, USP exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin tablets, USP are supplied as 125 mcg and 250 mcg tablets for oral administration. Each tablet contains the labeled amount of digoxin, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and corn starch. The 125 mcg tablets contain FD&C Yellow No. 5 (tartrazine). FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0115-9811-02",
"PackageDescription": "500 TABLET in 1 BOTTLE (0115-9811-02) ",
"NDC11Code": "00115-9811-02",
"ProductNDC": "0115-9811",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078556",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "125",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090720",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin, USP is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin, USP is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin, USP is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin, USP exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin tablets, USP are supplied as 125 mcg and 250 mcg tablets for oral administration. Each tablet contains the labeled amount of digoxin, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and corn starch. The 125 mcg tablets contain FD&C Yellow No. 5 (tartrazine). FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0115-9811-03",
"PackageDescription": "1000 TABLET in 1 BOTTLE (0115-9811-03) ",
"NDC11Code": "00115-9811-03",
"ProductNDC": "0115-9811",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078556",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "125",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090720",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin, USP is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin, USP is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin, USP is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin, USP exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin tablets, USP are supplied as 125 mcg and 250 mcg tablets for oral administration. Each tablet contains the labeled amount of digoxin, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and corn starch. The 125 mcg tablets contain FD&C Yellow No. 5 (tartrazine). FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0115-9822-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0115-9822-01) ",
"NDC11Code": "00115-9822-01",
"ProductNDC": "0115-9822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078556",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090720",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin, USP is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin, USP is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin, USP is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin, USP exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin tablets, USP are supplied as 125 mcg and 250 mcg tablets for oral administration. Each tablet contains the labeled amount of digoxin, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and corn starch. The 125 mcg tablets contain FD&C Yellow No. 5 (tartrazine). FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0115-9822-02",
"PackageDescription": "500 TABLET in 1 BOTTLE (0115-9822-02) ",
"NDC11Code": "00115-9822-02",
"ProductNDC": "0115-9822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078556",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090720",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin, USP is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin, USP is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin, USP is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin, USP exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin tablets, USP are supplied as 125 mcg and 250 mcg tablets for oral administration. Each tablet contains the labeled amount of digoxin, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and corn starch. The 125 mcg tablets contain FD&C Yellow No. 5 (tartrazine). FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0115-9822-03",
"PackageDescription": "1000 TABLET in 1 BOTTLE (0115-9822-03) ",
"NDC11Code": "00115-9822-03",
"ProductNDC": "0115-9822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078556",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090720",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin, USP is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin, USP is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin, USP is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin, USP exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin tablets, USP are supplied as 125 mcg and 250 mcg tablets for oral administration. Each tablet contains the labeled amount of digoxin, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and corn starch. The 125 mcg tablets contain FD&C Yellow No. 5 (tartrazine). FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0143-1240-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0143-1240-01) ",
"NDC11Code": "00143-1240-01",
"ProductNDC": "0143-1240",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077002",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "125",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20071030",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin Tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1) , 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2) , 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as 3β-[(O-2,6-Dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.94, and its structural formula is. Digoxin occurs as white or almost white powder, or colorless crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Tablets, USP are supplied as 125 mcg or 250 mcg tablets for oral administration. Each tablet contains the labeled amount of Digoxin, USP and the following inactive ingredients. 125 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, and starch 1500. 250 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and starch 1500."
},
{
"NDCCode": "0143-1240-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0143-1240-10) ",
"NDC11Code": "00143-1240-10",
"ProductNDC": "0143-1240",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077002",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "125",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20071030",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin Tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1) , 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2) , 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as 3β-[(O-2,6-Dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.94, and its structural formula is. Digoxin occurs as white or almost white powder, or colorless crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Tablets, USP are supplied as 125 mcg or 250 mcg tablets for oral administration. Each tablet contains the labeled amount of Digoxin, USP and the following inactive ingredients. 125 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, and starch 1500. 250 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and starch 1500."
},
{
"NDCCode": "0143-1241-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0143-1241-01) ",
"NDC11Code": "00143-1241-01",
"ProductNDC": "0143-1241",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077002",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20071030",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin Tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1) , 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2) , 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as 3β-[(O-2,6-Dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.94, and its structural formula is. Digoxin occurs as white or almost white powder, or colorless crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Tablets, USP are supplied as 125 mcg or 250 mcg tablets for oral administration. Each tablet contains the labeled amount of Digoxin, USP and the following inactive ingredients. 125 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, and starch 1500. 250 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and starch 1500."
},
{
"NDCCode": "0143-1241-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0143-1241-10) ",
"NDC11Code": "00143-1241-10",
"ProductNDC": "0143-1241",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077002",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20071030",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin Tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1) , 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2) , 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as 3β-[(O-2,6-Dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.94, and its structural formula is. Digoxin occurs as white or almost white powder, or colorless crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Tablets, USP are supplied as 125 mcg or 250 mcg tablets for oral administration. Each tablet contains the labeled amount of Digoxin, USP and the following inactive ingredients. 125 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, and starch 1500. 250 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and starch 1500."
},
{
"NDCCode": "0409-0829-01",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-0829-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0829-11) ",
"NDC11Code": "00409-0829-01",
"ProductNDC": "0409-0829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aztreonam",
"NonProprietaryName": "Aztreonam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20220124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206517",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "AZTREONAM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Monobactam Antibacterial [EPC], Monobactams [CS]",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220124",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Aztreonam for Injection, USP and other antibacterial drugs, aztreonam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Aztreonam for Injection is indicated for the treatment of the following infections caused by susceptible Gram-negative microorganisms. Urinary Tract Infections (complicated and uncomplicated), including pyelonephritis and cystitis (initial and recurrent) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Enterobacter cloacae, Klebsiella oxytocaEfficacy for this organism in this organ system was studied in fewer than 10 infections., Citrobacter species, and Serratia marcescens. Lower Respiratory Tract Infections, including pneumonia and bronchitis caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Haemophilus influenzae, Proteus mirabilis, Enterobacter species, and Serratia marcescens. Septicemia caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, Serratia marcescens, and Enterobacter species. Skin and Skin-Structure Infections, including those associated with postoperative wounds, ulcers, and burns, caused by Escherichia coli, Proteus mirabilis, Serratia marcescens, Enterobacter species, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Citrobacter species. Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella species including K. pneumoniae, Enterobacter species including E. cloacae, Pseudomonas aeruginosa, Citrobacter species including C. freundii, and Serratia species including S. marcescens. Gynecologic Infections, including endometritis and pelvic cellulitis caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter species including E. cloacae, and Proteus mirabilis. Aztreonam for Injection is indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms, including abscesses, infections complicating hollow viscus perforations, cutaneous infections, and infections of serous surfaces. Aztreonam for Injection is effective against most of the commonly encountered Gram-negative aerobic pathogens seen in general surgery.",
"Description": "Aztreonam for Injection, USP contains the active ingredient aztreonam, a monobactam. It was originally isolated from Chromobacterium violaceum. It is a synthetic bactericidal antibiotic. The monobactams, having a unique monocyclic beta-lactam nucleus, are structurally different from other beta-lactam antibiotics (eg, penicillins, cephalosporins, cephamycins). The sulfonic acid substituent in the 1-position of the ring activates the beta-lactam moiety; an aminothiazolyl oxime side chain in the 3-position and a methyl group in the 4-position confer the specific antibacterial spectrum and beta-lactamase stability. Aztreonam is designated chemically as (Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Structural formula. Aztreonam for Injection is a sterile, nonpyrogenic, sodium-free, lyophilized, off-white to slightly yellowish solid, containing approximately 780 mg arginine per gram of aztreonam. Following constitution, the product is for intramuscular or intravenous use. Aqueous solutions of the product have a pH in the range of 4.5 to 7.5."
},
{
"NDCCode": "0409-0830-01",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-0830-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0830-11) ",
"NDC11Code": "00409-0830-01",
"ProductNDC": "0409-0830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aztreonam",
"NonProprietaryName": "Aztreonam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20220124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206517",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "AZTREONAM",
"StrengthNumber": "2",
"StrengthUnit": "g/1",
"Pharm_Classes": "Monobactam Antibacterial [EPC], Monobactams [CS]",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220124",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Aztreonam for Injection, USP and other antibacterial drugs, aztreonam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Aztreonam for Injection is indicated for the treatment of the following infections caused by susceptible Gram-negative microorganisms. Urinary Tract Infections (complicated and uncomplicated), including pyelonephritis and cystitis (initial and recurrent) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Enterobacter cloacae, Klebsiella oxytocaEfficacy for this organism in this organ system was studied in fewer than 10 infections., Citrobacter species, and Serratia marcescens. Lower Respiratory Tract Infections, including pneumonia and bronchitis caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Haemophilus influenzae, Proteus mirabilis, Enterobacter species, and Serratia marcescens. Septicemia caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, Serratia marcescens, and Enterobacter species. Skin and Skin-Structure Infections, including those associated with postoperative wounds, ulcers, and burns, caused by Escherichia coli, Proteus mirabilis, Serratia marcescens, Enterobacter species, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Citrobacter species. Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella species including K. pneumoniae, Enterobacter species including E. cloacae, Pseudomonas aeruginosa, Citrobacter species including C. freundii, and Serratia species including S. marcescens. Gynecologic Infections, including endometritis and pelvic cellulitis caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter species including E. cloacae, and Proteus mirabilis. Aztreonam for Injection is indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms, including abscesses, infections complicating hollow viscus perforations, cutaneous infections, and infections of serous surfaces. Aztreonam for Injection is effective against most of the commonly encountered Gram-negative aerobic pathogens seen in general surgery.",
"Description": "Aztreonam for Injection, USP contains the active ingredient aztreonam, a monobactam. It was originally isolated from Chromobacterium violaceum. It is a synthetic bactericidal antibiotic. The monobactams, having a unique monocyclic beta-lactam nucleus, are structurally different from other beta-lactam antibiotics (eg, penicillins, cephalosporins, cephamycins). The sulfonic acid substituent in the 1-position of the ring activates the beta-lactam moiety; an aminothiazolyl oxime side chain in the 3-position and a methyl group in the 4-position confer the specific antibacterial spectrum and beta-lactamase stability. Aztreonam is designated chemically as (Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Structural formula. Aztreonam for Injection is a sterile, nonpyrogenic, sodium-free, lyophilized, off-white to slightly yellowish solid, containing approximately 780 mg arginine per gram of aztreonam. Following constitution, the product is for intramuscular or intravenous use. Aqueous solutions of the product have a pH in the range of 4.5 to 7.5."
},
{
"NDCCode": "0615-8202-05",
"PackageDescription": "15 TABLET in 1 BLISTER PACK (0615-8202-05) ",
"NDC11Code": "00615-8202-05",
"ProductNDC": "0615-8202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077002",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "125",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260707",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin Tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1) , 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2) , 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as 3β-[(O-2,6-Dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.94, and its structural formula is. Digoxin occurs as white or almost white powder, or colorless crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Tablets, USP are supplied as 125 mcg or 250 mcg tablets for oral administration. Each tablet contains the labeled amount of Digoxin, USP and the following inactive ingredients. 125 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, and starch 1500. 250 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and starch 1500."
},
{
"NDCCode": "0615-8202-39",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (0615-8202-39) ",
"NDC11Code": "00615-8202-39",
"ProductNDC": "0615-8202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077002",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "125",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260707",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin Tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1) , 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2) , 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as 3β-[(O-2,6-Dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.94, and its structural formula is. Digoxin occurs as white or almost white powder, or colorless crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Tablets, USP are supplied as 125 mcg or 250 mcg tablets for oral administration. Each tablet contains the labeled amount of Digoxin, USP and the following inactive ingredients. 125 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, and starch 1500. 250 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and starch 1500."
},
{
"NDCCode": "0641-1410-35",
"PackageDescription": "25 AMPULE in 1 CARTON (0641-1410-35) / 2 mL in 1 AMPULE (0641-1410-31) ",
"NDC11Code": "00641-1410-35",
"ProductNDC": "0641-1410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19751024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083391",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DIGOXIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19751024",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1) , 2 Control of resting ventricular rate in adults with chronic atrial fibrillation. (1.3) .",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin has the chemical name: 3β-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide, and the following structural formula. C41H64O14 MW 780.94. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Injection, USP is a sterile solution for slow intravenous or deep intramuscular injection. Each mL contains digoxin 250 mcg (0.25 mg), alcohol 0.1 mL, propylene glycol 0.4 mL, dibasic sodium phosphate, anhydrous 3 mg and citric acid, anhydrous 0.8 mg in Water for Injection. pH 6.7-7.3; citric acid and/or sodium phosphate added, if necessary, for pH adjustment. Dilution is not required."
},
{
"NDCCode": "0641-6184-25",
"PackageDescription": "25 AMPULE in 1 CARTON (0641-6184-25) / 2 mL in 1 AMPULE (0641-6184-01) ",
"NDC11Code": "00641-6184-25",
"ProductNDC": "0641-6184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19751024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083391",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DIGOXIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19751024",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1) , 2 Control of resting ventricular rate in adults with chronic atrial fibrillation. (1.3) .",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin has the chemical name: 3β-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide, and the following structural formula. C41H64O14 MW 780.94. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Injection, USP is a sterile solution for slow intravenous or deep intramuscular injection. Each mL contains digoxin 250 mcg (0.25 mg), alcohol 0.1 mL, propylene glycol 0.4 mL, dibasic sodium phosphate, anhydrous 3 mg and citric acid, anhydrous 0.8 mg in Water for Injection. pH 6.7-7.3; citric acid and/or sodium phosphate added, if necessary, for pH adjustment. Dilution is not required."
},
{
"NDCCode": "0781-3059-95",
"PackageDescription": "10 AMPULE in 1 CARTON (0781-3059-95) / 2 mL in 1 AMPULE (0781-3059-72) ",
"NDC11Code": "00781-3059-95",
"ProductNDC": "0781-3059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL",
"StartMarketingDate": "20030821",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040481",
"LabelerName": "Sandoz Inc",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "250",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030821",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin injection is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in adults with chronic atrial fibrillation. (1.3).",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin exists as clear to white odorless crystals or white, odorless crystalline powder that melts with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin injection, USP is a sterile solution of digoxin for intravenous or intramuscular injection. Each mL contains: digoxin 0.25 mg, propylene glycol 40% (v/v), anhydrous ethanol 10% (v/v), dibasic sodium phosphate 0.3% (w/v) and anhydrous citric acid 0.08% (w/v) to adjust pH between 6.8 and 7.2, and water for injection. Dilution is not required."
}
]
}
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<NDC>
<NDCCode>64538-780-79</NDCCode>
<PackageDescription>1 mg in 1 SYRINGE, GLASS (64538-780-79) </PackageDescription>
<NDC11Code>64538-0780-79</NDC11Code>
<ProductNDC>64538-780</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bimzelx</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20231017</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Rentschler Biopharma SE</LabelerName>
<SubstanceName>BIMEKIZUMAB</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/160mg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>17-OCT-23</StartMarketingDatePackage>
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<NDC>
<NDCCode>50474-780-79</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (50474-780-79) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>50474-0780-79</NDC11Code>
<ProductNDC>50474-780</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bimzelx</ProprietaryName>
<NonProprietaryName>Bimekizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20231017</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761151</ApplicationNumber>
<LabelerName>UCB, Inc.</LabelerName>
<SubstanceName>BIMEKIZUMAB</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .</IndicationAndUsage>
<Description>Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1.</Description>
</NDC>
<NDC>
<NDCCode>64538-001-00</NDCCode>
<PackageDescription>5 mL in 1 VIAL (64538-001-00) </PackageDescription>
<NDC11Code>64538-0001-00</NDC11Code>
<ProductNDC>64538-001</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mepsevii</NonProprietaryName>
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<StartMarketingDate>20171115</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Rentschler Biopharma SE</LabelerName>
<SubstanceName>VESTRONIDASE ALFA</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-NOV-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64538-002-00</NDCCode>
<PackageDescription>4 mg in 1 VIAL, SINGLE-DOSE (64538-002-00) </PackageDescription>
<NDC11Code>64538-0002-00</NDC11Code>
<ProductNDC>64538-002</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Epcoritamab-bysp</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<StartMarketingDate>20230519</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Rentschler Biopharma SE</LabelerName>
<SubstanceName>EPCORITAMAB</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/4mg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-10-15</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19-MAY-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64538-100-00</NDCCode>
<PackageDescription>1.8 mL in 1 VIAL, GLASS (64538-100-00) </PackageDescription>
<NDC11Code>64538-0100-00</NDC11Code>
<ProductNDC>64538-100</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<NonProprietaryName>Bnt162b2</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<StartMarketingDate>20201212</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Rentschler Biopharma SE</LabelerName>
<SubstanceName>BNT162B2</SubstanceName>
<StrengthNumber>.23</StrengthNumber>
<StrengthUnit>mg/1.8mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-DEC-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64538-141-00</NDCCode>
<PackageDescription>1 mg in 1 VIAL (64538-141-00)</PackageDescription>
<NDC11Code>64538-0141-00</NDC11Code>
<ProductNDC>64538-141</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<StartMarketingDate>20110822</StartMarketingDate>
<EndMarketingDate>20130924</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Rentschler Biotechnologie GmbH</LabelerName>
<SubstanceName>TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130924</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64538-180-00</NDCCode>
<PackageDescription>10 mg in 1 VIAL, SINGLE-DOSE (64538-180-00) </PackageDescription>
<NDC11Code>64538-0180-00</NDC11Code>
<ProductNDC>64538-180</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Velmanase Alfa-tycv</NonProprietaryName>
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<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Rentschler Biopharma SE</LabelerName>
<SubstanceName>VELMANASE ALFA-TYCV</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/10mg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-MAR-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64538-282-02</NDCCode>
<PackageDescription>1 mg in 1 VIAL, GLASS (64538-282-02) </PackageDescription>
<NDC11Code>64538-0282-02</NDC11Code>
<ProductNDC>64538-282</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Pivekimab Sunirine-pvzy</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<StartMarketingDate>20260527</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Rentschler Biopharma SE</LabelerName>
<SubstanceName>PIVEKIMAB SUNIRINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/2mg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-06-30</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>27-MAY-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64538-500-00</NDCCode>
<PackageDescription>1 mL in 1 VIAL (64538-500-00) </PackageDescription>
<NDC11Code>64538-0500-00</NDC11Code>
<ProductNDC>64538-500</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Antihemophilic Factor (recombinant), Porcine Sequence</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20141023</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Rentschler Biopharma SE</LabelerName>
<SubstanceName>SUSOCTOCOG ALFA</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-11-19</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-OCT-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64538-644-00</NDCCode>
<PackageDescription>5 mL in 1 VIAL, GLASS (64538-644-00) </PackageDescription>
<NDC11Code>64538-0644-00</NDC11Code>
<ProductNDC>64538-644</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Lanadelumab-flyo</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20180824</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Rentschler Biopharma SE</LabelerName>
<SubstanceName>LANADELUMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>24-AUG-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64538-702-00</NDCCode>
<PackageDescription>30 mg in 1 SYRINGE, GLASS (64538-702-00)</PackageDescription>
<NDC11Code>64538-0702-00</NDC11Code>
<ProductNDC>64538-702</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Icatibant Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20110825</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Rentschler Biopharma SE</LabelerName>
<SubstanceName>ICATIBANT ACETATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1000mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64538-824-00</NDCCode>
<PackageDescription>130 mg in 1 SYRINGE (64538-824-00) </PackageDescription>
<NDC11Code>64538-0824-00</NDC11Code>
<ProductNDC>64538-824</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ustekinumab-aauz</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<StartMarketingDate>20240222</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Rentschler Biopharma SE</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>130</StrengthNumber>
<StrengthUnit>mg/130mg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>22-FEB-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0054-0057-46</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (0054-0057-46) </PackageDescription>
<NDC11Code>00054-0057-46</NDC11Code>
<ProductNDC>0054-0057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Digoxin</ProprietaryName>
<NonProprietaryName>Digoxin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040826</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021648</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DIGOXIN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cardiac Glycoside [EPC], Cardiac Glycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-19</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Digoxin is a cardiac glycoside indicated in adults for the treatment of mild to moderate heart failure and for the control of resting ventricular rate in patients with chronic atrial fibrillation. (1.1, 1.3) In pediatric patients with heart failure, digoxin is indicated to increase myocardial contractility. (1.2).</IndicationAndUsage>
<Description>Digoxin is one of the cardiac glycosides, a closely-related group of plant-derived drugs with shared pharmacological effects. The term "digitalis" is used to designate the whole group. Digoxin is extracted from the leaves of the common foxglove, Digitalis lanata. Like each of the other cardiac glycosides, digoxin consists of a polycyclic core and a sugar side chain. Digoxin’s chemical name is 3β-[O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide; its structural formula is. Its molecular formula is C41H64O14, and its molecular weight is 780.94. Digoxin is practically insoluble in water and in ether, slightly soluble in 50% ethanol and in chloroform, and freely soluble in pyridine. Digoxin, USP is a white or almost white powder, or colorless crystals. Digoxin Oral Solution, USP is formulated for oral administration. Each mL contains 50 mcg digoxin. The lime-flavored solution contains the following inactive ingredients: alcohol 10% (by volume at 60°F), glycerin, lime (imitation), methylparaben 0.1%, propylparaben 0.02%, purified water, sodium citrate and sorbitol solution.</Description>
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<LastUpdate>2026-08-17</LastUpdate>
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<IndicationAndUsage>Digoxin tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin, USP is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin, USP is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin, USP is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin, USP exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin tablets, USP are supplied as 125 mcg and 250 mcg tablets for oral administration. Each tablet contains the labeled amount of digoxin, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and corn starch. The 125 mcg tablets contain FD&C Yellow No. 5 (tartrazine). FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Digoxin tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin, USP is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin, USP is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin, USP is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin, USP exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin tablets, USP are supplied as 125 mcg and 250 mcg tablets for oral administration. Each tablet contains the labeled amount of digoxin, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and corn starch. The 125 mcg tablets contain FD&C Yellow No. 5 (tartrazine). FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Digoxin tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin, USP is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin, USP is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin, USP is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin, USP exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin tablets, USP are supplied as 125 mcg and 250 mcg tablets for oral administration. Each tablet contains the labeled amount of digoxin, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and corn starch. The 125 mcg tablets contain FD&C Yellow No. 5 (tartrazine). FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Digoxin tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin, USP is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin, USP is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin, USP is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin, USP exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin tablets, USP are supplied as 125 mcg and 250 mcg tablets for oral administration. Each tablet contains the labeled amount of digoxin, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and corn starch. The 125 mcg tablets contain FD&C Yellow No. 5 (tartrazine). FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Digoxin tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin, USP is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin, USP is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin, USP is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin, USP exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin tablets, USP are supplied as 125 mcg and 250 mcg tablets for oral administration. Each tablet contains the labeled amount of digoxin, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and corn starch. The 125 mcg tablets contain FD&C Yellow No. 5 (tartrazine). FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Digoxin tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin, USP is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin, USP is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin, USP is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin, USP exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin tablets, USP are supplied as 125 mcg and 250 mcg tablets for oral administration. Each tablet contains the labeled amount of digoxin, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and corn starch. The 125 mcg tablets contain FD&C Yellow No. 5 (tartrazine). FDA approved dissolution test specifications differ from USP.</Description>
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<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
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<IndicationAndUsage>Digoxin Tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1) , 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2) , 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as 3β-[(O-2,6-Dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.94, and its structural formula is. Digoxin occurs as white or almost white powder, or colorless crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Tablets, USP are supplied as 125 mcg or 250 mcg tablets for oral administration. Each tablet contains the labeled amount of Digoxin, USP and the following inactive ingredients. 125 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, and starch 1500. 250 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and starch 1500.</Description>
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<IndicationAndUsage>Digoxin Tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1) , 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2) , 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as 3β-[(O-2,6-Dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.94, and its structural formula is. Digoxin occurs as white or almost white powder, or colorless crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Tablets, USP are supplied as 125 mcg or 250 mcg tablets for oral administration. Each tablet contains the labeled amount of Digoxin, USP and the following inactive ingredients. 125 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, and starch 1500. 250 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and starch 1500.</Description>
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<IndicationAndUsage>Digoxin Tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1) , 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2) , 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as 3β-[(O-2,6-Dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.94, and its structural formula is. Digoxin occurs as white or almost white powder, or colorless crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Tablets, USP are supplied as 125 mcg or 250 mcg tablets for oral administration. Each tablet contains the labeled amount of Digoxin, USP and the following inactive ingredients. 125 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, and starch 1500. 250 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and starch 1500.</Description>
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<IndicationAndUsage>Digoxin Tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1) , 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2) , 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as 3β-[(O-2,6-Dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.94, and its structural formula is. Digoxin occurs as white or almost white powder, or colorless crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Tablets, USP are supplied as 125 mcg or 250 mcg tablets for oral administration. Each tablet contains the labeled amount of Digoxin, USP and the following inactive ingredients. 125 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, and starch 1500. 250 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and starch 1500.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Aztreonam for Injection, USP and other antibacterial drugs, aztreonam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Aztreonam for Injection is indicated for the treatment of the following infections caused by susceptible Gram-negative microorganisms. Urinary Tract Infections (complicated and uncomplicated), including pyelonephritis and cystitis (initial and recurrent) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Enterobacter cloacae, Klebsiella oxytocaEfficacy for this organism in this organ system was studied in fewer than 10 infections., Citrobacter species, and Serratia marcescens. Lower Respiratory Tract Infections, including pneumonia and bronchitis caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Haemophilus influenzae, Proteus mirabilis, Enterobacter species, and Serratia marcescens. Septicemia caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, Serratia marcescens, and Enterobacter species. Skin and Skin-Structure Infections, including those associated with postoperative wounds, ulcers, and burns, caused by Escherichia coli, Proteus mirabilis, Serratia marcescens, Enterobacter species, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Citrobacter species. Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella species including K. pneumoniae, Enterobacter species including E. cloacae, Pseudomonas aeruginosa, Citrobacter species including C. freundii, and Serratia species including S. marcescens. Gynecologic Infections, including endometritis and pelvic cellulitis caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter species including E. cloacae, and Proteus mirabilis. Aztreonam for Injection is indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms, including abscesses, infections complicating hollow viscus perforations, cutaneous infections, and infections of serous surfaces. Aztreonam for Injection is effective against most of the commonly encountered Gram-negative aerobic pathogens seen in general surgery.</IndicationAndUsage>
<Description>Aztreonam for Injection, USP contains the active ingredient aztreonam, a monobactam. It was originally isolated from Chromobacterium violaceum. It is a synthetic bactericidal antibiotic. The monobactams, having a unique monocyclic beta-lactam nucleus, are structurally different from other beta-lactam antibiotics (eg, penicillins, cephalosporins, cephamycins). The sulfonic acid substituent in the 1-position of the ring activates the beta-lactam moiety; an aminothiazolyl oxime side chain in the 3-position and a methyl group in the 4-position confer the specific antibacterial spectrum and beta-lactamase stability. Aztreonam is designated chemically as (Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Structural formula. Aztreonam for Injection is a sterile, nonpyrogenic, sodium-free, lyophilized, off-white to slightly yellowish solid, containing approximately 780 mg arginine per gram of aztreonam. Following constitution, the product is for intramuscular or intravenous use. Aqueous solutions of the product have a pH in the range of 4.5 to 7.5.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Aztreonam for Injection, USP and other antibacterial drugs, aztreonam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Aztreonam for Injection is indicated for the treatment of the following infections caused by susceptible Gram-negative microorganisms. Urinary Tract Infections (complicated and uncomplicated), including pyelonephritis and cystitis (initial and recurrent) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Enterobacter cloacae, Klebsiella oxytocaEfficacy for this organism in this organ system was studied in fewer than 10 infections., Citrobacter species, and Serratia marcescens. Lower Respiratory Tract Infections, including pneumonia and bronchitis caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Haemophilus influenzae, Proteus mirabilis, Enterobacter species, and Serratia marcescens. Septicemia caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, Serratia marcescens, and Enterobacter species. Skin and Skin-Structure Infections, including those associated with postoperative wounds, ulcers, and burns, caused by Escherichia coli, Proteus mirabilis, Serratia marcescens, Enterobacter species, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Citrobacter species. Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella species including K. pneumoniae, Enterobacter species including E. cloacae, Pseudomonas aeruginosa, Citrobacter species including C. freundii, and Serratia species including S. marcescens. Gynecologic Infections, including endometritis and pelvic cellulitis caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter species including E. cloacae, and Proteus mirabilis. Aztreonam for Injection is indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms, including abscesses, infections complicating hollow viscus perforations, cutaneous infections, and infections of serous surfaces. Aztreonam for Injection is effective against most of the commonly encountered Gram-negative aerobic pathogens seen in general surgery.</IndicationAndUsage>
<Description>Aztreonam for Injection, USP contains the active ingredient aztreonam, a monobactam. It was originally isolated from Chromobacterium violaceum. It is a synthetic bactericidal antibiotic. The monobactams, having a unique monocyclic beta-lactam nucleus, are structurally different from other beta-lactam antibiotics (eg, penicillins, cephalosporins, cephamycins). The sulfonic acid substituent in the 1-position of the ring activates the beta-lactam moiety; an aminothiazolyl oxime side chain in the 3-position and a methyl group in the 4-position confer the specific antibacterial spectrum and beta-lactamase stability. Aztreonam is designated chemically as (Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Structural formula. Aztreonam for Injection is a sterile, nonpyrogenic, sodium-free, lyophilized, off-white to slightly yellowish solid, containing approximately 780 mg arginine per gram of aztreonam. Following constitution, the product is for intramuscular or intravenous use. Aqueous solutions of the product have a pH in the range of 4.5 to 7.5.</Description>
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<IndicationAndUsage>Digoxin Tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1) , 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2) , 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as 3β-[(O-2,6-Dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.94, and its structural formula is. Digoxin occurs as white or almost white powder, or colorless crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Tablets, USP are supplied as 125 mcg or 250 mcg tablets for oral administration. Each tablet contains the labeled amount of Digoxin, USP and the following inactive ingredients. 125 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, and starch 1500. 250 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and starch 1500.</Description>
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<IndicationAndUsage>Digoxin Tablets are a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1) , 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2) , 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as 3β-[(O-2,6-Dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.94, and its structural formula is. Digoxin occurs as white or almost white powder, or colorless crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Tablets, USP are supplied as 125 mcg or 250 mcg tablets for oral administration. Each tablet contains the labeled amount of Digoxin, USP and the following inactive ingredients. 125 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, and starch 1500. 250 mcg: anhydrous lactose, colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and starch 1500.</Description>
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<IndicationAndUsage>Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1) , 2 Control of resting ventricular rate in adults with chronic atrial fibrillation. (1.3) .</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin has the chemical name: 3β-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide, and the following structural formula. C41H64O14 MW 780.94. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Injection, USP is a sterile solution for slow intravenous or deep intramuscular injection. Each mL contains digoxin 250 mcg (0.25 mg), alcohol 0.1 mL, propylene glycol 0.4 mL, dibasic sodium phosphate, anhydrous 3 mg and citric acid, anhydrous 0.8 mg in Water for Injection. pH 6.7-7.3; citric acid and/or sodium phosphate added, if necessary, for pH adjustment. Dilution is not required.</Description>
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<IndicationAndUsage>Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1) , 2 Control of resting ventricular rate in adults with chronic atrial fibrillation. (1.3) .</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin has the chemical name: 3β-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide, and the following structural formula. C41H64O14 MW 780.94. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Injection, USP is a sterile solution for slow intravenous or deep intramuscular injection. Each mL contains digoxin 250 mcg (0.25 mg), alcohol 0.1 mL, propylene glycol 0.4 mL, dibasic sodium phosphate, anhydrous 3 mg and citric acid, anhydrous 0.8 mg in Water for Injection. pH 6.7-7.3; citric acid and/or sodium phosphate added, if necessary, for pH adjustment. Dilution is not required.</Description>
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<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Cardiac Glycoside [EPC], Cardiac Glycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Digoxin injection is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in adults with chronic atrial fibrillation. (1.3).</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin exists as clear to white odorless crystals or white, odorless crystalline powder that melts with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin injection, USP is a sterile solution of digoxin for intravenous or intramuscular injection. Each mL contains: digoxin 0.25 mg, propylene glycol 40% (v/v), anhydrous ethanol 10% (v/v), dibasic sodium phosphate 0.3% (w/v) and anhydrous citric acid 0.08% (w/v) to adjust pH between 6.8 and 7.2, and water for injection. Dilution is not required.</Description>
</NDC>
</NDCList>