{
"NDC": [
{
"NDCCode": "68516-5216-0",
"PackageDescription": "5 BAG in 1 CARTON (68516-5216-0) / 100 mL in 1 BAG (68516-5216-8) ",
"NDC11Code": "68516-5216-00",
"ProductNDC": "68516-5216",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albutein",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102478",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "ALBUTEIN 25% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Acute nephrosis. (1.3), 4 Hypoalbuminemia. (1.4), 5 Ovarian hyperstimulation syndrome. (1.5), 6 Neonatal hyperbilirubinemia. (1.6), 7 Adult respiratory distress syndrome (ARDS). (1.7), 8 Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.8).",
"Description": "ALBUTEIN 25% is a sterile, aqueous solution for single-dose intravenous administration containing 25% human albumin (weight/volume). ALBUTEIN 25% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 25% is approximately five times that of normal human plasma. A liter of ALBUTEIN 25% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 25% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 25% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses."
},
{
"NDCCode": "50090-5216-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-5216-0) ",
"NDC11Code": "50090-5216-00",
"ProductNDC": "50090-5216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Np Thyroid 60",
"NonProprietaryName": "Levothyroxine, Liothyronine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101111",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
"StrengthNumber": "38; 9",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]",
"Status": "Active",
"LastUpdate": "2023-05-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201006",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: NP Thyroid® tablets (thyroid tablets, USP) are indicated: 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.",
"Description": "NP Thyroid® (thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose (agglomerated) and mineral oil. Contains no ingredient made from a gluten-containing grain (wheat, barley, rye)."
},
{
"NDCCode": "54868-5216-0",
"PackageDescription": "15 g in 1 BOTTLE, PLASTIC (54868-5216-0)",
"NDC11Code": "54868-5216-00",
"ProductNDC": "54868-5216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064118",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/g",
"Pharm_Classes": "Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.",
"Description": "Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula. Nystatin Topical Powder USP is for dermatologic use. Nystatin Topical Powder USP contains 100,000 USP nystatin units per gram dispersed in talc."
},
{
"NDCCode": "68516-5216-1",
"PackageDescription": "1 VIAL in 1 CARTON (68516-5216-1) / 50 mL in 1 VIAL (68516-5216-3) ",
"NDC11Code": "68516-5216-01",
"ProductNDC": "68516-5216",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albutein",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102478",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "ALBUTEIN 25% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Acute nephrosis. (1.3), 4 Hypoalbuminemia. (1.4), 5 Ovarian hyperstimulation syndrome. (1.5), 6 Neonatal hyperbilirubinemia. (1.6), 7 Adult respiratory distress syndrome (ARDS). (1.7), 8 Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.8).",
"Description": "ALBUTEIN 25% is a sterile, aqueous solution for single-dose intravenous administration containing 25% human albumin (weight/volume). ALBUTEIN 25% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 25% is approximately five times that of normal human plasma. A liter of ALBUTEIN 25% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 25% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 25% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses."
},
{
"NDCCode": "68516-5216-2",
"PackageDescription": "1 VIAL in 1 CARTON (68516-5216-2) / 100 mL in 1 VIAL (68516-5216-4) ",
"NDC11Code": "68516-5216-02",
"ProductNDC": "68516-5216",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albutein",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102478",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "ALBUTEIN 25% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Acute nephrosis. (1.3), 4 Hypoalbuminemia. (1.4), 5 Ovarian hyperstimulation syndrome. (1.5), 6 Neonatal hyperbilirubinemia. (1.6), 7 Adult respiratory distress syndrome (ARDS). (1.7), 8 Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.8).",
"Description": "ALBUTEIN 25% is a sterile, aqueous solution for single-dose intravenous administration containing 25% human albumin (weight/volume). ALBUTEIN 25% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 25% is approximately five times that of normal human plasma. A liter of ALBUTEIN 25% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 25% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 25% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses."
},
{
"NDCCode": "68516-5216-5",
"PackageDescription": "1 VIAL in 1 CARTON (68516-5216-5) / 20 mL in 1 VIAL (68516-5216-6) ",
"NDC11Code": "68516-5216-05",
"ProductNDC": "68516-5216",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albutein",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102478",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "ALBUTEIN 25% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Acute nephrosis. (1.3), 4 Hypoalbuminemia. (1.4), 5 Ovarian hyperstimulation syndrome. (1.5), 6 Neonatal hyperbilirubinemia. (1.6), 7 Adult respiratory distress syndrome (ARDS). (1.7), 8 Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.8).",
"Description": "ALBUTEIN 25% is a sterile, aqueous solution for single-dose intravenous administration containing 25% human albumin (weight/volume). ALBUTEIN 25% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 25% is approximately five times that of normal human plasma. A liter of ALBUTEIN 25% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 25% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 25% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses."
},
{
"NDCCode": "68516-5216-7",
"PackageDescription": "50 mL in 1 BAG (68516-5216-7) ",
"NDC11Code": "68516-5216-07",
"ProductNDC": "68516-5216",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albutein",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102478",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2022-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191215",
"SamplePackage": "N"
},
{
"NDCCode": "68516-5216-8",
"PackageDescription": "100 mL in 1 BAG (68516-5216-8) ",
"NDC11Code": "68516-5216-08",
"ProductNDC": "68516-5216",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albutein",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102478",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2022-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191215",
"SamplePackage": "N"
},
{
"NDCCode": "68516-5216-9",
"PackageDescription": "5 BAG in 1 CARTON (68516-5216-9) / 50 mL in 1 BAG (68516-5216-7) ",
"NDC11Code": "68516-5216-09",
"ProductNDC": "68516-5216",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albutein",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102478",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "ALBUTEIN 25% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Acute nephrosis. (1.3), 4 Hypoalbuminemia. (1.4), 5 Ovarian hyperstimulation syndrome. (1.5), 6 Neonatal hyperbilirubinemia. (1.6), 7 Adult respiratory distress syndrome (ARDS). (1.7), 8 Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.8).",
"Description": "ALBUTEIN 25% is a sterile, aqueous solution for single-dose intravenous administration containing 25% human albumin (weight/volume). ALBUTEIN 25% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 25% is approximately five times that of normal human plasma. A liter of ALBUTEIN 25% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 25% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 25% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses."
},
{
"NDCCode": "68516-5214-0",
"PackageDescription": "2 BAG in 1 CARTON (68516-5214-0) / 500 mL in 1 BAG (68516-5214-8) ",
"NDC11Code": "68516-5214-00",
"ProductNDC": "68516-5214",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albutein",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20211108",
"EndMarketingDate": "20250724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102478",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/250mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2025-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211108",
"EndMarketingDatePackage": "20250724",
"SamplePackage": "N",
"IndicationAndUsage": "ALBUTEIN 5% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Hypoalbuminemia. (1.3), 4 Plasma exchange. (1.4).",
"Description": "ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma. A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses."
},
{
"NDCCode": "68516-5217-5",
"PackageDescription": "5 BAG in 1 CARTON (68516-5217-5) / 100 mL in 1 BAG (68516-5217-0) ",
"NDC11Code": "68516-5217-05",
"ProductNDC": "68516-5217",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albutein",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102478",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/250mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2024-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20231115",
"SamplePackage": "N",
"IndicationAndUsage": "ALBUTEIN 5% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Hypoalbuminemia. (1.3), 4 Plasma exchange. (1.4).",
"Description": "ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma. A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses."
},
{
"NDCCode": "68516-5218-1",
"PackageDescription": "1 BAG in 1 CARTON (68516-5218-1) / 250 mL in 1 BAG (68516-5218-0) ",
"NDC11Code": "68516-5218-01",
"ProductNDC": "68516-5218",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albutein",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102478",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/250mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231115",
"SamplePackage": "N",
"IndicationAndUsage": "ALBUTEIN 5% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Hypoalbuminemia. (1.3), 4 Plasma exchange. (1.4).",
"Description": "ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma. A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses."
},
{
"NDCCode": "68516-5218-4",
"PackageDescription": "4 BAG in 1 CARTON (68516-5218-4) / 250 mL in 1 BAG (68516-5218-0) ",
"NDC11Code": "68516-5218-04",
"ProductNDC": "68516-5218",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albutein",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102478",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/250mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231115",
"SamplePackage": "N",
"IndicationAndUsage": "ALBUTEIN 5% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Hypoalbuminemia. (1.3), 4 Plasma exchange. (1.4).",
"Description": "ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma. A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses."
},
{
"NDCCode": "68516-5219-1",
"PackageDescription": "1 BAG in 1 CARTON (68516-5219-1) / 500 mL in 1 BAG (68516-5219-0) ",
"NDC11Code": "68516-5219-01",
"ProductNDC": "68516-5219",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albutein",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231109",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102478",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/250mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231109",
"SamplePackage": "N",
"IndicationAndUsage": "ALBUTEIN 5% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Hypoalbuminemia. (1.3), 4 Plasma exchange. (1.4).",
"Description": "ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma. A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses."
},
{
"NDCCode": "68516-5219-2",
"PackageDescription": "2 BAG in 1 CARTON (68516-5219-2) / 500 mL in 1 BAG (68516-5219-0) ",
"NDC11Code": "68516-5219-02",
"ProductNDC": "68516-5219",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albutein",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231109",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102478",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/250mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231109",
"SamplePackage": "N",
"IndicationAndUsage": "ALBUTEIN 5% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Hypoalbuminemia. (1.3), 4 Plasma exchange. (1.4).",
"Description": "ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma. A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses."
},
{
"NDCCode": "68071-5216-1",
"PackageDescription": "100 mL in 1 BOTTLE (68071-5216-1) ",
"NDC11Code": "68071-5216-01",
"ProductNDC": "68071-5216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20020605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065066",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "200; 28.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-06-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200318",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat 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. Amoxicillin and clavulanate potassium tablets, USP, for oral suspension, USP, and chewable tablets, USP are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below.",
"Description": "Amoxicillin and clavulanate potassium tablets, USP; for oral suspension, USP; and chewable tablets, USP are oral antibacterial combinations consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( phydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8H 8KNO 5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)( 2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Inactive Ingredients: 1 Tablets – Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide, triethyl citrate, ethylcellulose, cetyl alcohol and sodium lauryl sulfate. In addition, the 875 mg/125 mg tablet contains crospovidone. Each tablet of amoxicillin and clavulanate potassium contains 0.63 mEq potassium. , 2 For Oral Suspension – Aspartame, colloidal silicon dioxide, hydroxypropyl methylcellulose, mannitol, orange flavoring, precipitated silicon dioxide, succinic acid, xanthan gum, and golden syrup flavoring (caramel). , 3 Chewable Tablets – Aspartame, banana flavoring, cherry flavoring, colloidal silicon dioxide, FD&C Red No. 40, magnesium stearate, mannitol, and sodium starch glycolate. [ see Warnings and Precautions ( 5.6)] Each 200-mg chewable tablet and each 5 mL of reconstituted 200 mg/5 mL oral suspension of amoxicillin and clavulanate potassium contains 0.14 mEq potassium Each 400-mg chewable tablet and each 5 mL of reconstituted 400 mg/5 mL oral suspension of amoxicillin and clavulanate potassium contains 0.29 mEq potassium ."
},
{
"NDCCode": "68516-3607-2",
"PackageDescription": "1 KIT in 1 CARTON (68516-3607-2) * 10 mL in 1 VIAL (68516-3604-2) * 10 mL in 1 VIAL, SINGLE-DOSE (68516-1002-2) ",
"NDC11Code": "68516-3607-02",
"ProductNDC": "68516-3607",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Alphanine",
"ProprietaryNameSuffix": "Sd",
"NonProprietaryName": "Coagulation Factor Ix (human)",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19901231",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103249",
"LabelerName": "GRIFOLS USA, LLC",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19901231",
"SamplePackage": "N",
"IndicationAndUsage": "AlphaNine SD is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. AlphaNine SD contains low, non-therapeutic levels of Factors II, VII, and X, and, therefore, is not indicated for the treatment of Factor II, VII or X deficiencies. This product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia A patients with inhibitors to Factor VIII.",
"Description": "Coagulation Factor IX (Human), AlphaNine® SD, is a purified, solvent detergent treated, virus filtered preparation of Factor IX derived from human plasma.1 It contains a minimum of 150 IU Factor IX/mg protein; levels of Factor VII (proconvertin), Factor II (prothrombin) and Factor X (Stuart-Prower Factor) which are below the limit of detection (less than 0.04 Factor VII unit, less than 0.05 Factor II unit, and less than 0.05 Factor X unit per IU Factor IX). AlphaNine SD is a sterile, lyophilized preparation intended for intravenous administration only. Each vial is a single dose container. AlphaNine SD is labeled with the Factor IX potency expressed in International Units (IU). AlphaNine SD contains not more than (NMT) 0.04 unit of heparin, NMT 0.2 mg of dextrose, NMT 1.0 μg polysorbate 80 and NMT 0.10 μg tri(n-butyl) phosphate/IU of Factor IX. Contains no preservatives."
},
{
"NDCCode": "68516-3608-2",
"PackageDescription": "1 KIT in 1 CARTON (68516-3608-2) * 10 mL in 1 VIAL (68516-3605-2) * 10 mL in 1 VIAL, SINGLE-DOSE (68516-1002-2) ",
"NDC11Code": "68516-3608-02",
"ProductNDC": "68516-3608",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Alphanine",
"ProprietaryNameSuffix": "Sd",
"NonProprietaryName": "Coagulation Factor Ix (human)",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19901231",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103249",
"LabelerName": "GRIFOLS USA, LLC",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19901231",
"SamplePackage": "N",
"IndicationAndUsage": "AlphaNine SD is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. AlphaNine SD contains low, non-therapeutic levels of Factors II, VII, and X, and, therefore, is not indicated for the treatment of Factor II, VII or X deficiencies. This product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia A patients with inhibitors to Factor VIII.",
"Description": "Coagulation Factor IX (Human), AlphaNine® SD, is a purified, solvent detergent treated, virus filtered preparation of Factor IX derived from human plasma.1 It contains a minimum of 150 IU Factor IX/mg protein; levels of Factor VII (proconvertin), Factor II (prothrombin) and Factor X (Stuart-Prower Factor) which are below the limit of detection (less than 0.04 Factor VII unit, less than 0.05 Factor II unit, and less than 0.05 Factor X unit per IU Factor IX). AlphaNine SD is a sterile, lyophilized preparation intended for intravenous administration only. Each vial is a single dose container. AlphaNine SD is labeled with the Factor IX potency expressed in International Units (IU). AlphaNine SD contains not more than (NMT) 0.04 unit of heparin, NMT 0.2 mg of dextrose, NMT 1.0 μg polysorbate 80 and NMT 0.10 μg tri(n-butyl) phosphate/IU of Factor IX. Contains no preservatives."
},
{
"NDCCode": "68516-3609-2",
"PackageDescription": "1 KIT in 1 CARTON (68516-3609-2) * 10 mL in 1 VIAL (68516-3606-2) * 10 mL in 1 VIAL, SINGLE-DOSE (68516-1002-2) ",
"NDC11Code": "68516-3609-02",
"ProductNDC": "68516-3609",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Alphanine",
"ProprietaryNameSuffix": "Sd",
"NonProprietaryName": "Coagulation Factor Ix (human)",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19901231",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103249",
"LabelerName": "GRIFOLS USA, LLC",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19901231",
"SamplePackage": "N",
"IndicationAndUsage": "AlphaNine SD is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. AlphaNine SD contains low, non-therapeutic levels of Factors II, VII, and X, and, therefore, is not indicated for the treatment of Factor II, VII or X deficiencies. This product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia A patients with inhibitors to Factor VIII.",
"Description": "Coagulation Factor IX (Human), AlphaNine® SD, is a purified, solvent detergent treated, virus filtered preparation of Factor IX derived from human plasma.1 It contains a minimum of 150 IU Factor IX/mg protein; levels of Factor VII (proconvertin), Factor II (prothrombin) and Factor X (Stuart-Prower Factor) which are below the limit of detection (less than 0.04 Factor VII unit, less than 0.05 Factor II unit, and less than 0.05 Factor X unit per IU Factor IX). AlphaNine SD is a sterile, lyophilized preparation intended for intravenous administration only. Each vial is a single dose container. AlphaNine SD is labeled with the Factor IX potency expressed in International Units (IU). AlphaNine SD contains not more than (NMT) 0.04 unit of heparin, NMT 0.2 mg of dextrose, NMT 1.0 μg polysorbate 80 and NMT 0.10 μg tri(n-butyl) phosphate/IU of Factor IX. Contains no preservatives."
},
{
"NDCCode": "68516-3610-2",
"PackageDescription": "1 KIT in 1 CARTON (68516-3610-2) * 10 mL in 1 VIAL (68516-3604-2) * 10 mL in 1 VIAL, GLASS (76297-002-12) ",
"NDC11Code": "68516-3610-02",
"ProductNDC": "68516-3610",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Alphanine",
"ProprietaryNameSuffix": "Sd",
"NonProprietaryName": "Coagulation Factor Ix (human)",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19901231",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103249",
"LabelerName": "GRIFOLS USA, LLC",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19901231",
"SamplePackage": "N",
"IndicationAndUsage": "AlphaNine SD is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. AlphaNine SD contains low, non-therapeutic levels of Factors II, VII, and X, and, therefore, is not indicated for the treatment of Factor II, VII or X deficiencies. This product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia A patients with inhibitors to Factor VIII.",
"Description": "Coagulation Factor IX (Human), AlphaNine® SD, is a purified, solvent detergent treated, virus filtered preparation of Factor IX derived from human plasma.1 It contains a minimum of 150 IU Factor IX/mg protein; levels of Factor VII (proconvertin), Factor II (prothrombin) and Factor X (Stuart-Prower Factor) which are below the limit of detection (less than 0.04 Factor VII unit, less than 0.05 Factor II unit, and less than 0.05 Factor X unit per IU Factor IX). AlphaNine SD is a sterile, lyophilized preparation intended for intravenous administration only. Each vial is a single dose container. AlphaNine SD is labeled with the Factor IX potency expressed in International Units (IU). AlphaNine SD contains not more than (NMT) 0.04 unit of heparin, NMT 0.2 mg of dextrose, NMT 1.0 μg polysorbate 80 and NMT 0.10 μg tri(n-butyl) phosphate/IU of Factor IX. Contains no preservatives."
},
{
"NDCCode": "68516-3611-2",
"PackageDescription": "1 KIT in 1 CARTON (68516-3611-2) * 10 mL in 1 VIAL (68516-3605-2) * 10 mL in 1 VIAL, GLASS (76297-002-12) ",
"NDC11Code": "68516-3611-02",
"ProductNDC": "68516-3611",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Alphanine",
"ProprietaryNameSuffix": "Sd",
"NonProprietaryName": "Coagulation Factor Ix (human)",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19901231",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103249",
"LabelerName": "GRIFOLS USA, LLC",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19901231",
"SamplePackage": "N",
"IndicationAndUsage": "AlphaNine SD is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. AlphaNine SD contains low, non-therapeutic levels of Factors II, VII, and X, and, therefore, is not indicated for the treatment of Factor II, VII or X deficiencies. This product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia A patients with inhibitors to Factor VIII.",
"Description": "Coagulation Factor IX (Human), AlphaNine® SD, is a purified, solvent detergent treated, virus filtered preparation of Factor IX derived from human plasma.1 It contains a minimum of 150 IU Factor IX/mg protein; levels of Factor VII (proconvertin), Factor II (prothrombin) and Factor X (Stuart-Prower Factor) which are below the limit of detection (less than 0.04 Factor VII unit, less than 0.05 Factor II unit, and less than 0.05 Factor X unit per IU Factor IX). AlphaNine SD is a sterile, lyophilized preparation intended for intravenous administration only. Each vial is a single dose container. AlphaNine SD is labeled with the Factor IX potency expressed in International Units (IU). AlphaNine SD contains not more than (NMT) 0.04 unit of heparin, NMT 0.2 mg of dextrose, NMT 1.0 μg polysorbate 80 and NMT 0.10 μg tri(n-butyl) phosphate/IU of Factor IX. Contains no preservatives."
},
{
"NDCCode": "68516-3612-2",
"PackageDescription": "1 KIT in 1 CARTON (68516-3612-2) * 10 mL in 1 VIAL (68516-3606-2) * 10 mL in 1 VIAL, GLASS (76297-002-12) ",
"NDC11Code": "68516-3612-02",
"ProductNDC": "68516-3612",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Alphanine",
"ProprietaryNameSuffix": "Sd",
"NonProprietaryName": "Coagulation Factor Ix (human)",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19901231",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103249",
"LabelerName": "GRIFOLS USA, LLC",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19901231",
"SamplePackage": "N",
"IndicationAndUsage": "AlphaNine SD is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. AlphaNine SD contains low, non-therapeutic levels of Factors II, VII, and X, and, therefore, is not indicated for the treatment of Factor II, VII or X deficiencies. This product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia A patients with inhibitors to Factor VIII.",
"Description": "Coagulation Factor IX (Human), AlphaNine® SD, is a purified, solvent detergent treated, virus filtered preparation of Factor IX derived from human plasma.1 It contains a minimum of 150 IU Factor IX/mg protein; levels of Factor VII (proconvertin), Factor II (prothrombin) and Factor X (Stuart-Prower Factor) which are below the limit of detection (less than 0.04 Factor VII unit, less than 0.05 Factor II unit, and less than 0.05 Factor X unit per IU Factor IX). AlphaNine SD is a sterile, lyophilized preparation intended for intravenous administration only. Each vial is a single dose container. AlphaNine SD is labeled with the Factor IX potency expressed in International Units (IU). AlphaNine SD contains not more than (NMT) 0.04 unit of heparin, NMT 0.2 mg of dextrose, NMT 1.0 μg polysorbate 80 and NMT 0.10 μg tri(n-butyl) phosphate/IU of Factor IX. Contains no preservatives."
},
{
"NDCCode": "68516-5214-1",
"PackageDescription": "1 VIAL in 1 CARTON (68516-5214-1) / 250 mL in 1 VIAL (68516-5214-3) ",
"NDC11Code": "68516-5214-01",
"ProductNDC": "68516-5214",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albutein",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102478",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/250mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "ALBUTEIN 5% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Hypoalbuminemia. (1.3), 4 Plasma exchange. (1.4).",
"Description": "ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma. A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses."
},
{
"NDCCode": "68516-5214-2",
"PackageDescription": "1 VIAL in 1 CARTON (68516-5214-2) / 500 mL in 1 VIAL (68516-5214-4) ",
"NDC11Code": "68516-5214-02",
"ProductNDC": "68516-5214",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Albutein",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102478",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "12.5",
"StrengthUnit": "g/250mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
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},
{
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"Description": "ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma. A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses."
},
{
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"ProductNDC": "68516-5215",
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"IndicationAndUsage": "ALBUTEIN 20% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Acute nephrosis. (1.3), 4 Hypoalbuminemia. (1.4), 5 Ovarian hyperstimulation syndrome. (1.5), 6 Neonatal hyperbilirubinemia. (1.6), 7 Adult respiratory distress syndrome (ARDS). (1.7), 8 Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.8).",
"Description": "ALBUTEIN 20% is a sterile, aqueous solution for single dose intravenous administration containing 20% human albumin (weight/volume). ALBUTEIN 20% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 20% is approximately four times that of normal human plasma. A liter of ALBUTEIN 20% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 20% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 20% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses."
},
{
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},
{
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"IndicationAndUsage": "ALBUTEIN 20% is an albumin solution indicated for: 1 Hypovolemia. (1.1) , 2 Cardiopulmonary bypass procedures. (1.2), 3 Acute nephrosis. (1.3), 4 Hypoalbuminemia. (1.4), 5 Ovarian hyperstimulation syndrome. (1.5) , 6 Neonatal hyperbilirubinemia. (1.6) , 7 Adult respiratory distress syndrome (ARDS). (1.7), 8 Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.8).",
"Description": "ALBUTEIN 20% is a sterile, aqueous solution for single dose intravenous administration containing 20% human albumin (weight/volume). ALBUTEIN 20% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 20% is approximately four times that of normal human plasma. A liter of ALBUTEIN 20% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 20% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 20% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses."
},
{
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"Description": "ALBUTEIN 20% is a sterile, aqueous solution for single dose intravenous administration containing 20% human albumin (weight/volume). ALBUTEIN 20% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 20% is approximately four times that of normal human plasma. A liter of ALBUTEIN 20% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 20% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 20% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>68516-5216-0</NDCCode>
<PackageDescription>5 BAG in 1 CARTON (68516-5216-0) / 100 mL in 1 BAG (68516-5216-8) </PackageDescription>
<NDC11Code>68516-5216-00</NDC11Code>
<ProductNDC>68516-5216</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
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<MarketingCategoryName>BLA</MarketingCategoryName>
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<LabelerName>GRIFOLS USA, LLC</LabelerName>
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<Status>Active</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 25% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Acute nephrosis. (1.3), 4 Hypoalbuminemia. (1.4), 5 Ovarian hyperstimulation syndrome. (1.5), 6 Neonatal hyperbilirubinemia. (1.6), 7 Adult respiratory distress syndrome (ARDS). (1.7), 8 Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.8).</IndicationAndUsage>
<Description>ALBUTEIN 25% is a sterile, aqueous solution for single-dose intravenous administration containing 25% human albumin (weight/volume). ALBUTEIN 25% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 25% is approximately five times that of normal human plasma. A liter of ALBUTEIN 25% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 25% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 25% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
<NDC>
<NDCCode>50090-5216-0</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-5216-0) </PackageDescription>
<NDC11Code>50090-5216-00</NDC11Code>
<ProductNDC>50090-5216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Np Thyroid 60</ProprietaryName>
<NonProprietaryName>Levothyroxine, Liothyronine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101111</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LEVOTHYROXINE; LIOTHYRONINE</SubstanceName>
<StrengthNumber>38; 9</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: NP Thyroid® tablets (thyroid tablets, USP) are indicated: 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.</IndicationAndUsage>
<Description>NP Thyroid® (thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose (agglomerated) and mineral oil. Contains no ingredient made from a gluten-containing grain (wheat, barley, rye).</Description>
</NDC>
<NDC>
<NDCCode>54868-5216-0</NDCCode>
<PackageDescription>15 g in 1 BOTTLE, PLASTIC (54868-5216-0)</PackageDescription>
<NDC11Code>54868-5216-00</NDC11Code>
<ProductNDC>54868-5216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20050127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064118</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.</IndicationAndUsage>
<Description>Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula. Nystatin Topical Powder USP is for dermatologic use. Nystatin Topical Powder USP contains 100,000 USP nystatin units per gram dispersed in talc.</Description>
</NDC>
<NDC>
<NDCCode>68516-5216-1</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (68516-5216-1) / 50 mL in 1 VIAL (68516-5216-3) </PackageDescription>
<NDC11Code>68516-5216-01</NDC11Code>
<ProductNDC>68516-5216</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
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<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 25% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Acute nephrosis. (1.3), 4 Hypoalbuminemia. (1.4), 5 Ovarian hyperstimulation syndrome. (1.5), 6 Neonatal hyperbilirubinemia. (1.6), 7 Adult respiratory distress syndrome (ARDS). (1.7), 8 Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.8).</IndicationAndUsage>
<Description>ALBUTEIN 25% is a sterile, aqueous solution for single-dose intravenous administration containing 25% human albumin (weight/volume). ALBUTEIN 25% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 25% is approximately five times that of normal human plasma. A liter of ALBUTEIN 25% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 25% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 25% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
<NDC>
<NDCCode>68516-5216-2</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (68516-5216-2) / 100 mL in 1 VIAL (68516-5216-4) </PackageDescription>
<NDC11Code>68516-5216-02</NDC11Code>
<ProductNDC>68516-5216</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 25% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Acute nephrosis. (1.3), 4 Hypoalbuminemia. (1.4), 5 Ovarian hyperstimulation syndrome. (1.5), 6 Neonatal hyperbilirubinemia. (1.6), 7 Adult respiratory distress syndrome (ARDS). (1.7), 8 Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.8).</IndicationAndUsage>
<Description>ALBUTEIN 25% is a sterile, aqueous solution for single-dose intravenous administration containing 25% human albumin (weight/volume). ALBUTEIN 25% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 25% is approximately five times that of normal human plasma. A liter of ALBUTEIN 25% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 25% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 25% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
<NDC>
<NDCCode>68516-5216-5</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (68516-5216-5) / 20 mL in 1 VIAL (68516-5216-6) </PackageDescription>
<NDC11Code>68516-5216-05</NDC11Code>
<ProductNDC>68516-5216</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 25% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Acute nephrosis. (1.3), 4 Hypoalbuminemia. (1.4), 5 Ovarian hyperstimulation syndrome. (1.5), 6 Neonatal hyperbilirubinemia. (1.6), 7 Adult respiratory distress syndrome (ARDS). (1.7), 8 Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.8).</IndicationAndUsage>
<Description>ALBUTEIN 25% is a sterile, aqueous solution for single-dose intravenous administration containing 25% human albumin (weight/volume). ALBUTEIN 25% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 25% is approximately five times that of normal human plasma. A liter of ALBUTEIN 25% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 25% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 25% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
<NDC>
<NDCCode>68516-5216-7</NDCCode>
<PackageDescription>50 mL in 1 BAG (68516-5216-7) </PackageDescription>
<NDC11Code>68516-5216-07</NDC11Code>
<ProductNDC>68516-5216</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20191215</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68516-5216-8</NDCCode>
<PackageDescription>100 mL in 1 BAG (68516-5216-8) </PackageDescription>
<NDC11Code>68516-5216-08</NDC11Code>
<ProductNDC>68516-5216</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20191215</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68516-5216-9</NDCCode>
<PackageDescription>5 BAG in 1 CARTON (68516-5216-9) / 50 mL in 1 BAG (68516-5216-7) </PackageDescription>
<NDC11Code>68516-5216-09</NDC11Code>
<ProductNDC>68516-5216</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 25% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Acute nephrosis. (1.3), 4 Hypoalbuminemia. (1.4), 5 Ovarian hyperstimulation syndrome. (1.5), 6 Neonatal hyperbilirubinemia. (1.6), 7 Adult respiratory distress syndrome (ARDS). (1.7), 8 Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.8).</IndicationAndUsage>
<Description>ALBUTEIN 25% is a sterile, aqueous solution for single-dose intravenous administration containing 25% human albumin (weight/volume). ALBUTEIN 25% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 25% is approximately five times that of normal human plasma. A liter of ALBUTEIN 25% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 25% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 25% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
<NDC>
<NDCCode>68516-5214-0</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (68516-5214-0) / 500 mL in 1 BAG (68516-5214-8) </PackageDescription>
<NDC11Code>68516-5214-00</NDC11Code>
<ProductNDC>68516-5214</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20211108</StartMarketingDate>
<EndMarketingDate>20250724</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/250mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211108</StartMarketingDatePackage>
<EndMarketingDatePackage>20250724</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 5% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Hypoalbuminemia. (1.3), 4 Plasma exchange. (1.4).</IndicationAndUsage>
<Description>ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma. A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
<NDC>
<NDCCode>68516-5217-5</NDCCode>
<PackageDescription>5 BAG in 1 CARTON (68516-5217-5) / 100 mL in 1 BAG (68516-5217-0) </PackageDescription>
<NDC11Code>68516-5217-05</NDC11Code>
<ProductNDC>68516-5217</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/250mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 5% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Hypoalbuminemia. (1.3), 4 Plasma exchange. (1.4).</IndicationAndUsage>
<Description>ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma. A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
<NDC>
<NDCCode>68516-5218-1</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (68516-5218-1) / 250 mL in 1 BAG (68516-5218-0) </PackageDescription>
<NDC11Code>68516-5218-01</NDC11Code>
<ProductNDC>68516-5218</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/250mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 5% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Hypoalbuminemia. (1.3), 4 Plasma exchange. (1.4).</IndicationAndUsage>
<Description>ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma. A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
<NDC>
<NDCCode>68516-5218-4</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (68516-5218-4) / 250 mL in 1 BAG (68516-5218-0) </PackageDescription>
<NDC11Code>68516-5218-04</NDC11Code>
<ProductNDC>68516-5218</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/250mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 5% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Hypoalbuminemia. (1.3), 4 Plasma exchange. (1.4).</IndicationAndUsage>
<Description>ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma. A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
<NDC>
<NDCCode>68516-5219-1</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (68516-5219-1) / 500 mL in 1 BAG (68516-5219-0) </PackageDescription>
<NDC11Code>68516-5219-01</NDC11Code>
<ProductNDC>68516-5219</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231109</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/250mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 5% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Hypoalbuminemia. (1.3), 4 Plasma exchange. (1.4).</IndicationAndUsage>
<Description>ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma. A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
<NDC>
<NDCCode>68516-5219-2</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (68516-5219-2) / 500 mL in 1 BAG (68516-5219-0) </PackageDescription>
<NDC11Code>68516-5219-02</NDC11Code>
<ProductNDC>68516-5219</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231109</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/250mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 5% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Hypoalbuminemia. (1.3), 4 Plasma exchange. (1.4).</IndicationAndUsage>
<Description>ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma. A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
<NDC>
<NDCCode>68071-5216-1</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (68071-5216-1) </PackageDescription>
<NDC11Code>68071-5216-01</NDC11Code>
<ProductNDC>68071-5216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065066</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>200; 28.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat 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. Amoxicillin and clavulanate potassium tablets, USP, for oral suspension, USP, and chewable tablets, USP are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below.</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium tablets, USP; for oral suspension, USP; and chewable tablets, USP are oral antibacterial combinations consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( phydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8H 8KNO 5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)( 2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Inactive Ingredients: 1 Tablets – Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide, triethyl citrate, ethylcellulose, cetyl alcohol and sodium lauryl sulfate. In addition, the 875 mg/125 mg tablet contains crospovidone. Each tablet of amoxicillin and clavulanate potassium contains 0.63 mEq potassium. , 2 For Oral Suspension – Aspartame, colloidal silicon dioxide, hydroxypropyl methylcellulose, mannitol, orange flavoring, precipitated silicon dioxide, succinic acid, xanthan gum, and golden syrup flavoring (caramel). , 3 Chewable Tablets – Aspartame, banana flavoring, cherry flavoring, colloidal silicon dioxide, FD&C Red No. 40, magnesium stearate, mannitol, and sodium starch glycolate. [ see Warnings and Precautions ( 5.6)] Each 200-mg chewable tablet and each 5 mL of reconstituted 200 mg/5 mL oral suspension of amoxicillin and clavulanate potassium contains 0.14 mEq potassium Each 400-mg chewable tablet and each 5 mL of reconstituted 400 mg/5 mL oral suspension of amoxicillin and clavulanate potassium contains 0.29 mEq potassium .</Description>
</NDC>
<NDC>
<NDCCode>68516-3607-2</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (68516-3607-2) * 10 mL in 1 VIAL (68516-3604-2) * 10 mL in 1 VIAL, SINGLE-DOSE (68516-1002-2) </PackageDescription>
<NDC11Code>68516-3607-02</NDC11Code>
<ProductNDC>68516-3607</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Alphanine</ProprietaryName>
<ProprietaryNameSuffix>Sd</ProprietaryNameSuffix>
<NonProprietaryName>Coagulation Factor Ix (human)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19901231</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103249</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19901231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AlphaNine SD is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. AlphaNine SD contains low, non-therapeutic levels of Factors II, VII, and X, and, therefore, is not indicated for the treatment of Factor II, VII or X deficiencies. This product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia A patients with inhibitors to Factor VIII.</IndicationAndUsage>
<Description>Coagulation Factor IX (Human), AlphaNine® SD, is a purified, solvent detergent treated, virus filtered preparation of Factor IX derived from human plasma.1 It contains a minimum of 150 IU Factor IX/mg protein; levels of Factor VII (proconvertin), Factor II (prothrombin) and Factor X (Stuart-Prower Factor) which are below the limit of detection (less than 0.04 Factor VII unit, less than 0.05 Factor II unit, and less than 0.05 Factor X unit per IU Factor IX). AlphaNine SD is a sterile, lyophilized preparation intended for intravenous administration only. Each vial is a single dose container. AlphaNine SD is labeled with the Factor IX potency expressed in International Units (IU). AlphaNine SD contains not more than (NMT) 0.04 unit of heparin, NMT 0.2 mg of dextrose, NMT 1.0 μg polysorbate 80 and NMT 0.10 μg tri(n-butyl) phosphate/IU of Factor IX. Contains no preservatives.</Description>
</NDC>
<NDC>
<NDCCode>68516-3608-2</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (68516-3608-2) * 10 mL in 1 VIAL (68516-3605-2) * 10 mL in 1 VIAL, SINGLE-DOSE (68516-1002-2) </PackageDescription>
<NDC11Code>68516-3608-02</NDC11Code>
<ProductNDC>68516-3608</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Alphanine</ProprietaryName>
<ProprietaryNameSuffix>Sd</ProprietaryNameSuffix>
<NonProprietaryName>Coagulation Factor Ix (human)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19901231</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103249</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19901231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AlphaNine SD is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. AlphaNine SD contains low, non-therapeutic levels of Factors II, VII, and X, and, therefore, is not indicated for the treatment of Factor II, VII or X deficiencies. This product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia A patients with inhibitors to Factor VIII.</IndicationAndUsage>
<Description>Coagulation Factor IX (Human), AlphaNine® SD, is a purified, solvent detergent treated, virus filtered preparation of Factor IX derived from human plasma.1 It contains a minimum of 150 IU Factor IX/mg protein; levels of Factor VII (proconvertin), Factor II (prothrombin) and Factor X (Stuart-Prower Factor) which are below the limit of detection (less than 0.04 Factor VII unit, less than 0.05 Factor II unit, and less than 0.05 Factor X unit per IU Factor IX). AlphaNine SD is a sterile, lyophilized preparation intended for intravenous administration only. Each vial is a single dose container. AlphaNine SD is labeled with the Factor IX potency expressed in International Units (IU). AlphaNine SD contains not more than (NMT) 0.04 unit of heparin, NMT 0.2 mg of dextrose, NMT 1.0 μg polysorbate 80 and NMT 0.10 μg tri(n-butyl) phosphate/IU of Factor IX. Contains no preservatives.</Description>
</NDC>
<NDC>
<NDCCode>68516-3609-2</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (68516-3609-2) * 10 mL in 1 VIAL (68516-3606-2) * 10 mL in 1 VIAL, SINGLE-DOSE (68516-1002-2) </PackageDescription>
<NDC11Code>68516-3609-02</NDC11Code>
<ProductNDC>68516-3609</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Alphanine</ProprietaryName>
<ProprietaryNameSuffix>Sd</ProprietaryNameSuffix>
<NonProprietaryName>Coagulation Factor Ix (human)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19901231</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103249</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19901231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AlphaNine SD is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. AlphaNine SD contains low, non-therapeutic levels of Factors II, VII, and X, and, therefore, is not indicated for the treatment of Factor II, VII or X deficiencies. This product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia A patients with inhibitors to Factor VIII.</IndicationAndUsage>
<Description>Coagulation Factor IX (Human), AlphaNine® SD, is a purified, solvent detergent treated, virus filtered preparation of Factor IX derived from human plasma.1 It contains a minimum of 150 IU Factor IX/mg protein; levels of Factor VII (proconvertin), Factor II (prothrombin) and Factor X (Stuart-Prower Factor) which are below the limit of detection (less than 0.04 Factor VII unit, less than 0.05 Factor II unit, and less than 0.05 Factor X unit per IU Factor IX). AlphaNine SD is a sterile, lyophilized preparation intended for intravenous administration only. Each vial is a single dose container. AlphaNine SD is labeled with the Factor IX potency expressed in International Units (IU). AlphaNine SD contains not more than (NMT) 0.04 unit of heparin, NMT 0.2 mg of dextrose, NMT 1.0 μg polysorbate 80 and NMT 0.10 μg tri(n-butyl) phosphate/IU of Factor IX. Contains no preservatives.</Description>
</NDC>
<NDC>
<NDCCode>68516-3610-2</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (68516-3610-2) * 10 mL in 1 VIAL (68516-3604-2) * 10 mL in 1 VIAL, GLASS (76297-002-12) </PackageDescription>
<NDC11Code>68516-3610-02</NDC11Code>
<ProductNDC>68516-3610</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Alphanine</ProprietaryName>
<ProprietaryNameSuffix>Sd</ProprietaryNameSuffix>
<NonProprietaryName>Coagulation Factor Ix (human)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19901231</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103249</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19901231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AlphaNine SD is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. AlphaNine SD contains low, non-therapeutic levels of Factors II, VII, and X, and, therefore, is not indicated for the treatment of Factor II, VII or X deficiencies. This product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia A patients with inhibitors to Factor VIII.</IndicationAndUsage>
<Description>Coagulation Factor IX (Human), AlphaNine® SD, is a purified, solvent detergent treated, virus filtered preparation of Factor IX derived from human plasma.1 It contains a minimum of 150 IU Factor IX/mg protein; levels of Factor VII (proconvertin), Factor II (prothrombin) and Factor X (Stuart-Prower Factor) which are below the limit of detection (less than 0.04 Factor VII unit, less than 0.05 Factor II unit, and less than 0.05 Factor X unit per IU Factor IX). AlphaNine SD is a sterile, lyophilized preparation intended for intravenous administration only. Each vial is a single dose container. AlphaNine SD is labeled with the Factor IX potency expressed in International Units (IU). AlphaNine SD contains not more than (NMT) 0.04 unit of heparin, NMT 0.2 mg of dextrose, NMT 1.0 μg polysorbate 80 and NMT 0.10 μg tri(n-butyl) phosphate/IU of Factor IX. Contains no preservatives.</Description>
</NDC>
<NDC>
<NDCCode>68516-3611-2</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (68516-3611-2) * 10 mL in 1 VIAL (68516-3605-2) * 10 mL in 1 VIAL, GLASS (76297-002-12) </PackageDescription>
<NDC11Code>68516-3611-02</NDC11Code>
<ProductNDC>68516-3611</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Alphanine</ProprietaryName>
<ProprietaryNameSuffix>Sd</ProprietaryNameSuffix>
<NonProprietaryName>Coagulation Factor Ix (human)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19901231</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103249</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19901231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AlphaNine SD is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. AlphaNine SD contains low, non-therapeutic levels of Factors II, VII, and X, and, therefore, is not indicated for the treatment of Factor II, VII or X deficiencies. This product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia A patients with inhibitors to Factor VIII.</IndicationAndUsage>
<Description>Coagulation Factor IX (Human), AlphaNine® SD, is a purified, solvent detergent treated, virus filtered preparation of Factor IX derived from human plasma.1 It contains a minimum of 150 IU Factor IX/mg protein; levels of Factor VII (proconvertin), Factor II (prothrombin) and Factor X (Stuart-Prower Factor) which are below the limit of detection (less than 0.04 Factor VII unit, less than 0.05 Factor II unit, and less than 0.05 Factor X unit per IU Factor IX). AlphaNine SD is a sterile, lyophilized preparation intended for intravenous administration only. Each vial is a single dose container. AlphaNine SD is labeled with the Factor IX potency expressed in International Units (IU). AlphaNine SD contains not more than (NMT) 0.04 unit of heparin, NMT 0.2 mg of dextrose, NMT 1.0 μg polysorbate 80 and NMT 0.10 μg tri(n-butyl) phosphate/IU of Factor IX. Contains no preservatives.</Description>
</NDC>
<NDC>
<NDCCode>68516-3612-2</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (68516-3612-2) * 10 mL in 1 VIAL (68516-3606-2) * 10 mL in 1 VIAL, GLASS (76297-002-12) </PackageDescription>
<NDC11Code>68516-3612-02</NDC11Code>
<ProductNDC>68516-3612</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Alphanine</ProprietaryName>
<ProprietaryNameSuffix>Sd</ProprietaryNameSuffix>
<NonProprietaryName>Coagulation Factor Ix (human)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19901231</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103249</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19901231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AlphaNine SD is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. AlphaNine SD contains low, non-therapeutic levels of Factors II, VII, and X, and, therefore, is not indicated for the treatment of Factor II, VII or X deficiencies. This product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia A patients with inhibitors to Factor VIII.</IndicationAndUsage>
<Description>Coagulation Factor IX (Human), AlphaNine® SD, is a purified, solvent detergent treated, virus filtered preparation of Factor IX derived from human plasma.1 It contains a minimum of 150 IU Factor IX/mg protein; levels of Factor VII (proconvertin), Factor II (prothrombin) and Factor X (Stuart-Prower Factor) which are below the limit of detection (less than 0.04 Factor VII unit, less than 0.05 Factor II unit, and less than 0.05 Factor X unit per IU Factor IX). AlphaNine SD is a sterile, lyophilized preparation intended for intravenous administration only. Each vial is a single dose container. AlphaNine SD is labeled with the Factor IX potency expressed in International Units (IU). AlphaNine SD contains not more than (NMT) 0.04 unit of heparin, NMT 0.2 mg of dextrose, NMT 1.0 μg polysorbate 80 and NMT 0.10 μg tri(n-butyl) phosphate/IU of Factor IX. Contains no preservatives.</Description>
</NDC>
<NDC>
<NDCCode>68516-5214-1</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (68516-5214-1) / 250 mL in 1 VIAL (68516-5214-3) </PackageDescription>
<NDC11Code>68516-5214-01</NDC11Code>
<ProductNDC>68516-5214</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/250mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 5% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Hypoalbuminemia. (1.3), 4 Plasma exchange. (1.4).</IndicationAndUsage>
<Description>ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma. A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
<NDC>
<NDCCode>68516-5214-2</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (68516-5214-2) / 500 mL in 1 VIAL (68516-5214-4) </PackageDescription>
<NDC11Code>68516-5214-02</NDC11Code>
<ProductNDC>68516-5214</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/250mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 5% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Hypoalbuminemia. (1.3), 4 Plasma exchange. (1.4).</IndicationAndUsage>
<Description>ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma. A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
<NDC>
<NDCCode>68516-5214-5</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (68516-5214-5) / 50 mL in 1 VIAL (68516-5214-6) </PackageDescription>
<NDC11Code>68516-5214-05</NDC11Code>
<ProductNDC>68516-5214</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/250mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 5% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Hypoalbuminemia. (1.3), 4 Plasma exchange. (1.4).</IndicationAndUsage>
<Description>ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma. A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
<NDC>
<NDCCode>68516-5214-9</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (68516-5214-9) / 250 mL in 1 BAG (68516-5214-7) </PackageDescription>
<NDC11Code>68516-5214-09</NDC11Code>
<ProductNDC>68516-5214</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20211108</StartMarketingDate>
<EndMarketingDate>20250724</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>g/250mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211108</StartMarketingDatePackage>
<EndMarketingDatePackage>20250724</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 5% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Hypoalbuminemia. (1.3), 4 Plasma exchange. (1.4).</IndicationAndUsage>
<Description>ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma. A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
<NDC>
<NDCCode>68516-5215-1</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (68516-5215-1) / 50 mL in 1 VIAL (68516-5215-3) </PackageDescription>
<NDC11Code>68516-5215-01</NDC11Code>
<ProductNDC>68516-5215</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 20% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Acute nephrosis. (1.3), 4 Hypoalbuminemia. (1.4), 5 Ovarian hyperstimulation syndrome. (1.5), 6 Neonatal hyperbilirubinemia. (1.6), 7 Adult respiratory distress syndrome (ARDS). (1.7), 8 Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.8).</IndicationAndUsage>
<Description>ALBUTEIN 20% is a sterile, aqueous solution for single dose intravenous administration containing 20% human albumin (weight/volume). ALBUTEIN 20% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 20% is approximately four times that of normal human plasma. A liter of ALBUTEIN 20% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 20% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 20% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
<NDC>
<NDCCode>68516-5215-2</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (68516-5215-2) / 100 mL in 1 VIAL (68516-5215-4) </PackageDescription>
<NDC11Code>68516-5215-02</NDC11Code>
<ProductNDC>68516-5215</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 20% is an albumin solution indicated for: 1 Hypovolemia. (1.1), 2 Cardiopulmonary bypass procedures. (1.2), 3 Acute nephrosis. (1.3), 4 Hypoalbuminemia. (1.4), 5 Ovarian hyperstimulation syndrome. (1.5), 6 Neonatal hyperbilirubinemia. (1.6), 7 Adult respiratory distress syndrome (ARDS). (1.7), 8 Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.8).</IndicationAndUsage>
<Description>ALBUTEIN 20% is a sterile, aqueous solution for single dose intravenous administration containing 20% human albumin (weight/volume). ALBUTEIN 20% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 20% is approximately four times that of normal human plasma. A liter of ALBUTEIN 20% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 20% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 20% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
<NDC>
<NDCCode>68516-5215-7</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (68516-5215-7) / 50 mL in 1 BAG (68516-5215-5) </PackageDescription>
<NDC11Code>68516-5215-07</NDC11Code>
<ProductNDC>68516-5215</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20211108</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 20% is an albumin solution indicated for: 1 Hypovolemia. (1.1) , 2 Cardiopulmonary bypass procedures. (1.2), 3 Acute nephrosis. (1.3), 4 Hypoalbuminemia. (1.4), 5 Ovarian hyperstimulation syndrome. (1.5) , 6 Neonatal hyperbilirubinemia. (1.6) , 7 Adult respiratory distress syndrome (ARDS). (1.7), 8 Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.8).</IndicationAndUsage>
<Description>ALBUTEIN 20% is a sterile, aqueous solution for single dose intravenous administration containing 20% human albumin (weight/volume). ALBUTEIN 20% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 20% is approximately four times that of normal human plasma. A liter of ALBUTEIN 20% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 20% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 20% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
<NDC>
<NDCCode>68516-5215-8</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (68516-5215-8) / 100 mL in 1 BAG (68516-5215-6) </PackageDescription>
<NDC11Code>68516-5215-08</NDC11Code>
<ProductNDC>68516-5215</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Albutein</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20211108</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102478</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALBUTEIN 20% is an albumin solution indicated for: 1 Hypovolemia. (1.1) , 2 Cardiopulmonary bypass procedures. (1.2), 3 Acute nephrosis. (1.3), 4 Hypoalbuminemia. (1.4), 5 Ovarian hyperstimulation syndrome. (1.5) , 6 Neonatal hyperbilirubinemia. (1.6) , 7 Adult respiratory distress syndrome (ARDS). (1.7), 8 Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.8).</IndicationAndUsage>
<Description>ALBUTEIN 20% is a sterile, aqueous solution for single dose intravenous administration containing 20% human albumin (weight/volume). ALBUTEIN 20% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 20% is approximately four times that of normal human plasma. A liter of ALBUTEIN 20% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. ALBUTEIN 20% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 20% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.</Description>
</NDC>
</NDCList>