{
"NDC": [
{
"NDCCode": "44206-418-12",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (44206-418-12) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (44206-418-92) ",
"NDC11Code": "44206-0418-12",
"ProductNDC": "44206-418",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Carimune",
"ProprietaryNameSuffix": "Nanofiltered",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090210",
"EndMarketingDate": "20210531",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102367",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "12",
"StrengthUnit": "g/1",
"Pharm_Classes": "Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090210",
"EndMarketingDatePackage": "20210531",
"SamplePackage": "N"
},
{
"NDCCode": "12634-418-52",
"PackageDescription": "12 TABLET in 1 BLISTER PACK (12634-418-52)",
"NDC11Code": "12634-0418-52",
"ProductNDC": "12634-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091179",
"LabelerName": "Apotheca, Inc",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Promethazine hydrochloride tablets are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled. Preoperative, postoperative and obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Sedation in both children and adults as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Promethazine Hydrochloride, a phenothiazine derivative, is designated chemically as 10- [2-(Dimethylamino)propyl]phenothiazine monohydochloride and has the following structural formula. Promethazine hydrochloride is a racemic compound; the empirical formula is C17H20N2S HCl and its molecular weight is 320.88.Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg promethazine hydrochloride, USP. The inactive ingredients include: lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The 50 mg also contains D&C Red # 27 Lake."
},
{
"NDCCode": "12634-418-82",
"PackageDescription": "12 TABLET in 1 BOTTLE (12634-418-82)",
"NDC11Code": "12634-0418-82",
"ProductNDC": "12634-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091179",
"LabelerName": "Apotheca, Inc",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Promethazine hydrochloride tablets are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled. Preoperative, postoperative and obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Sedation in both children and adults as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Promethazine Hydrochloride, a phenothiazine derivative, is designated chemically as 10- [2-(Dimethylamino)propyl]phenothiazine monohydochloride and has the following structural formula. Promethazine hydrochloride is a racemic compound; the empirical formula is C17H20N2S HCl and its molecular weight is 320.88.Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg promethazine hydrochloride, USP. The inactive ingredients include: lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The 50 mg also contains D&C Red # 27 Lake."
},
{
"NDCCode": "16729-418-12",
"PackageDescription": "1 KIT in 1 KIT (16729-418-12) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-416-54) * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-417-46) ",
"NDC11Code": "16729-0418-12",
"ProductNDC": "16729-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20220926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210499",
"LabelerName": "Accord Healthcare Inc.",
"Status": "Deprecated",
"LastUpdate": "2024-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220926",
"SamplePackage": "N",
"IndicationAndUsage": "Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl fumarate delayed-release capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C 6H 8O 4). It has the following structure:. Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: silicified microcrystalline cellulose, croscarmellose sodium, talc, colloidal anhydrous silica, magnesium stearate, triethyl citrate, methacrylic acid copolymer, methacrylic acid - methyl methacrylate copolymer (1:1). The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, titanium dioxide, FD&C blue 1, iron oxide black, iron oxide yellow, shellac, propylene glycol."
},
{
"NDCCode": "33342-418-12",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-418-12) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "33342-0418-12",
"ProductNDC": "33342-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212987",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240908",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release tablets are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium chloride extended-release tablets are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, colorless crystals or a white crystalline powder. It is odorless with a salty taste, freely soluble in water, practically insoluble in ethanol. Inactive Ingredients: Hydrogenated vegetable oil, colloidal-silicon-dioxide, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP. FDA approved acceptance criteria for assay differs from USP test."
},
{
"NDCCode": "46122-418-62",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (46122-418-62) / 12 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "46122-0418-62",
"ProductNDC": "46122-418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold Flu Severe",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180701",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "AmeriSource Bergen",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 200; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180701",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of the following cold/flu symptoms: minor aches and painsheadachesore throatnasal congestioncough. helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. temporarily reduces fever."
},
{
"NDCCode": "63517-418-16",
"PackageDescription": "12 BOTTLE, PUMP in 1 CASE (63517-418-16) > 473 mL in 1 BOTTLE, PUMP",
"NDC11Code": "63517-0418-16",
"ProductNDC": "63517-418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cardinal Health Antimicrobial Soap With Triclosan",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110314",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Cardinal Health",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".003",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64980-418-12",
"PackageDescription": "120 TABLET in 1 BOTTLE (64980-418-12) ",
"NDC11Code": "64980-0418-12",
"ProductNDC": "64980-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208371",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190225",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains 250 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 3.57 and is practically insoluble in water. The pKa at about 25°C is 3.06. Abiraterone acetate Tablets, USP are available in 250 mg uncoated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate."
},
{
"NDCCode": "68428-418-12",
"PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-418-12) ",
"NDC11Code": "68428-0418-12",
"ProductNDC": "68428-418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hamamelis Virginiana",
"NonProprietaryName": "Hamamelis Virginiana Root Bark/stem Bark",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. HAMAMELIS Varicose veins."
},
{
"NDCCode": "69168-013-15",
"PackageDescription": "1 KIT in 1 CARTON (69168-013-15) * 2 BLISTER PACK in 1 CARTON (69168-474-93) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (69168-418-86) / 12 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "69168-0013-15",
"ProductNDC": "69168-013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime And Nighttime Cold And Flu Kit",
"NonProprietaryName": "Daytime And Nighttime Cold And Flu Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20260306",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Allegiant Health",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260306",
"SamplePackage": "N",
"IndicationAndUsage": "DAYTIME ONLY. temporarily relieves these symptoms due to a cold or flu: 1 cough , 2 sore throat , 3 headache, 4 minor aches and pains , 5 temporarily reduces fever."
},
{
"NDCCode": "69168-438-15",
"PackageDescription": "1 KIT in 1 CARTON (69168-438-15) * 2 BLISTER PACK in 1 CARTON (69168-417-93) / 12 CAPSULE in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (69168-418-86) / 12 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "69168-0438-15",
"ProductNDC": "69168-438",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime Nighttime Cold And Flu Relief Combo Pack",
"NonProprietaryName": "Daytime Nighttime Cold And Flu",
"DosageFormName": "KIT",
"StartMarketingDate": "20220520",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Allegiant Health",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220520",
"SamplePackage": "N",
"IndicationAndUsage": "DAYTIME ONLY. temporarily relieves common cold/flu symptoms: nasalcongestion cough due to minor throat & bronchial irritation sorethroat headache minor aches & pains fever. NIGHTTIME ONLY. temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing."
},
{
"NDCCode": "79903-418-24",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (79903-418-24) / 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "79903-0418-24",
"ProductNDC": "79903-418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Nighttime Vapor Ice Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260708",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "WALMART INC.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "325; 10; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260708",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold/flu symptoms:cough due to minor throat and bronchial irritationcough to help you sleepsore throatheadacheminor aches and painsfeverrunny nose and sneezing."
},
{
"NDCCode": "85828-418-93",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (85828-418-93) / 12 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "85828-0418-93",
"ProductNDC": "85828-418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Cold And Flu Relief",
"NonProprietaryName": "Nighttime Cold And Flu Relief",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260325",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Grocery Outlet",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "325; 15; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260325",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold and flu symptoms: 1 cough due to minor throat and bronchial irritation, 2 sore throat, 3 headache, 4 minor aches and pains, 5 fever, 6 runny nose and sneezing."
},
{
"NDCCode": "44206-251-05",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (44206-251-05) > 50 mL in 1 VIAL, GLASS (44206-251-90) ",
"NDC11Code": "44206-0251-05",
"ProductNDC": "44206-251",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Alburx",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090106",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102366",
"LabelerName": "CSL Behring AG",
"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": "2022-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090106",
"SamplePackage": "N",
"Description": "ALBURX® 25, Albumin (Human) 25% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. The solution is clear and slightly viscous; it is almost colorless, or yellow, amber, or green. This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 0.14 M (3.2 mg/mL) sodium. The aluminum content is ≤ 200 mcg/L and the potassium content is ≤ 0.002 M. The solution is stabilized with 0.02 M sodium N-acetyltryptophanate and 0.02 M sodium caprylate. The solution contains no preservative."
},
{
"NDCCode": "44206-251-10",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (44206-251-10) > 100 mL in 1 VIAL, GLASS (44206-251-91) ",
"NDC11Code": "44206-0251-10",
"ProductNDC": "44206-251",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Alburx",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090106",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102366",
"LabelerName": "CSL Behring AG",
"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": "2022-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090106",
"SamplePackage": "N",
"Description": "ALBURX® 25, Albumin (Human) 25% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. The solution is clear and slightly viscous; it is almost colorless, or yellow, amber, or green. This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 0.14 M (3.2 mg/mL) sodium. The aluminum content is ≤ 200 mcg/L and the potassium content is ≤ 0.002 M. The solution is stabilized with 0.02 M sodium N-acetyltryptophanate and 0.02 M sodium caprylate. The solution contains no preservative."
},
{
"NDCCode": "44206-300-01",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (44206-300-01) / 2 mL in 1 SYRINGE, GLASS (44206-300-90) ",
"NDC11Code": "44206-0300-01",
"ProductNDC": "44206-300",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Rhophylac",
"NonProprietaryName": "Human Rho(d) Immune Globulin",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20090106",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125070",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN RHO(D) IMMUNE GLOBULIN",
"StrengthNumber": "1500",
"StrengthUnit": "[iU]/2mL",
"Pharm_Classes": "Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090106",
"SamplePackage": "N",
"IndicationAndUsage": "RHOPHYLAC is a Rh(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the suppression of Rh isoimmunization in non-sensitized Rh(D)-negative patients and for the treatment of immune thrombocytopenic purpura (ITP) in Rh(D)-positive patients.",
"Description": "RHOPHYLAC is a sterile Rh(D) Immune Globulin Intravenous (Human) (anti-D) solution in a ready-to-use prefilled glass syringe for intravenous or intramuscular injection. One syringe contains at least 1500 IU (300 mcg) of IgG antibodies to Rh(D) in a 2 mL solution, sufficient to suppress the immune response to at least 15 mL of Rh(D)-positive RBCs.1 The product potency is expressed in IUs by comparison to the World Health Organization (WHO) standard, which is also the US and the European Pharmacopoeia standard. Plasma is obtained from healthy Rh(D)-negative donors who have been immunized with Rh(D)-positive RBCs. The donors are screened carefully to reduce the risk of receiving donations containing blood-borne pathogens. Each plasma donation used in the manufacture of RHOPHYLAC is tested for the presence of HBV surface antigen (HBsAg), HIV-1/2, and HCV antibodies. In addition, plasma used in the manufacture of RHOPHYLAC is tested by FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV, and HIV-1 and found to be negative. The source plasma is also tested by NAT for hepatitis A virus (HAV) and B19 virus (B19V). RHOPHYLAC is produced by an ion-exchange chromatography isolation procedure5, using pooled plasma obtained by plasmapheresis of immunized Rh(D)-negative US donors. The manufacturing process of RHOPHYLAC includes two dedicated virus reduction steps (i.e., solvent/detergent treatment and virus filtration with a Planova® 15 nanometer (nm) virus filter) as well as one ion exchange chromatography step contributing to virus reduction.6,7 All three virus reduction steps have been independently validated in a series of in vitro experiments for their capacity to inactivate or remove enveloped and/or non-enveloped viruses. Virus models were chosen to cover a broad selection of viruses, including the major blood-transmissible viruses like human immunodeficiency virus, hepatitis B and hepatitis C virus, as well as small, non-enveloped viruses like hepatitis A virus and human parvovirus B19. Viral clearance data from validation studies of the dedicated virus reduction steps for both enveloped and nonenveloped viruses will be provided upon request by calling 1-800-504-5434. Overall virus reduction expressed as mean log10 reduction factor of model enveloped and non-enveloped viruses has been shown to be ≥11 log10 and ≥9 log10 respectively. RHOPHYLAC contains a maximum of 30 mg/mL of human plasma proteins, 10 mg/mL of which is human albumin added as a stabilizer. Prior to the addition of the stabilizer, RHOPHYLAC has a purity greater than 95% IgG. RHOPHYLAC contains less than 5 mcg/mL of IgA, which is the limit of detection. Additional excipients are approximately 20 mg/mL of glycine and up to 0.25 M of sodium chloride. RHOPHYLAC contains no preservative. Human albumin is manufactured from pooled plasma of US donors by cold ethanol fractionation, followed by pasteurization."
},
{
"NDCCode": "44206-300-10",
"PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (44206-300-10) / 2 mL in 1 SYRINGE, GLASS (44206-300-90) ",
"NDC11Code": "44206-0300-10",
"ProductNDC": "44206-300",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Rhophylac",
"NonProprietaryName": "Human Rho(d) Immune Globulin",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20090106",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125070",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN RHO(D) IMMUNE GLOBULIN",
"StrengthNumber": "1500",
"StrengthUnit": "[iU]/2mL",
"Pharm_Classes": "Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090106",
"SamplePackage": "N",
"IndicationAndUsage": "RHOPHYLAC is a Rh(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the suppression of Rh isoimmunization in non-sensitized Rh(D)-negative patients and for the treatment of immune thrombocytopenic purpura (ITP) in Rh(D)-positive patients.",
"Description": "RHOPHYLAC is a sterile Rh(D) Immune Globulin Intravenous (Human) (anti-D) solution in a ready-to-use prefilled glass syringe for intravenous or intramuscular injection. One syringe contains at least 1500 IU (300 mcg) of IgG antibodies to Rh(D) in a 2 mL solution, sufficient to suppress the immune response to at least 15 mL of Rh(D)-positive RBCs.1 The product potency is expressed in IUs by comparison to the World Health Organization (WHO) standard, which is also the US and the European Pharmacopoeia standard. Plasma is obtained from healthy Rh(D)-negative donors who have been immunized with Rh(D)-positive RBCs. The donors are screened carefully to reduce the risk of receiving donations containing blood-borne pathogens. Each plasma donation used in the manufacture of RHOPHYLAC is tested for the presence of HBV surface antigen (HBsAg), HIV-1/2, and HCV antibodies. In addition, plasma used in the manufacture of RHOPHYLAC is tested by FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV, and HIV-1 and found to be negative. The source plasma is also tested by NAT for hepatitis A virus (HAV) and B19 virus (B19V). RHOPHYLAC is produced by an ion-exchange chromatography isolation procedure5, using pooled plasma obtained by plasmapheresis of immunized Rh(D)-negative US donors. The manufacturing process of RHOPHYLAC includes two dedicated virus reduction steps (i.e., solvent/detergent treatment and virus filtration with a Planova® 15 nanometer (nm) virus filter) as well as one ion exchange chromatography step contributing to virus reduction.6,7 All three virus reduction steps have been independently validated in a series of in vitro experiments for their capacity to inactivate or remove enveloped and/or non-enveloped viruses. Virus models were chosen to cover a broad selection of viruses, including the major blood-transmissible viruses like human immunodeficiency virus, hepatitis B and hepatitis C virus, as well as small, non-enveloped viruses like hepatitis A virus and human parvovirus B19. Viral clearance data from validation studies of the dedicated virus reduction steps for both enveloped and nonenveloped viruses will be provided upon request by calling 1-800-504-5434. Overall virus reduction expressed as mean log10 reduction factor of model enveloped and non-enveloped viruses has been shown to be ≥11 log10 and ≥9 log10 respectively. RHOPHYLAC contains a maximum of 30 mg/mL of human plasma proteins, 10 mg/mL of which is human albumin added as a stabilizer. Prior to the addition of the stabilizer, RHOPHYLAC has a purity greater than 95% IgG. RHOPHYLAC contains less than 5 mcg/mL of IgA, which is the limit of detection. Additional excipients are approximately 20 mg/mL of glycine and up to 0.25 M of sodium chloride. RHOPHYLAC contains no preservative. Human albumin is manufactured from pooled plasma of US donors by cold ethanol fractionation, followed by pasteurization."
},
{
"NDCCode": "44206-310-25",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (44206-310-25) / 250 mL in 1 VIAL, GLASS (44206-310-90) ",
"NDC11Code": "44206-0310-25",
"ProductNDC": "44206-310",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Alburx",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090106",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102366",
"LabelerName": "CSL Behring AG",
"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": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090106",
"SamplePackage": "N",
"IndicationAndUsage": "The definitive treatment of major hemorrhage is the transfusion of red blood cells restoring a normal oxygen transport capacity of the blood. Since, however, the life-threatening event in major hemorrhage is the loss of blood volume and not the erythrocyte deficit, the blood volume can, as an emergency measure, be supported by ALBURX® 5, Albumin (Human) 5% solution or another rapidly acting plasma substitute if blood is not immediately available. This will restore cardiac output and abolish circulatory failure with tissue anoxia. Though a four- to fivefold volume of crystalloids may be equally effective, their administration takes more time and creates a general overload with sodium and water. In the presence of dehydration, electrolyte solutions such as Ringer's lactate should be administered in conjunction with albumin.",
"Description": "ALBURX® 5, Albumin (Human) 5% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. The solution is clear and slightly viscous; it is almost colorless, or yellow, amber, or green. This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 0.14 M (3.2 mg/mL) sodium. The aluminum content is ≤ 200 mcg/L and the potassium content is ≤ 0.002 M. The solution is stabilized with 0.004 M sodium N-acetyltryptophanate and 0.004 M sodium caprylate. The solution contains no preservative."
},
{
"NDCCode": "44206-310-50",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (44206-310-50) / 500 mL in 1 VIAL, GLASS (44206-310-91) ",
"NDC11Code": "44206-0310-50",
"ProductNDC": "44206-310",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Alburx",
"NonProprietaryName": "Albumin (human)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090106",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102366",
"LabelerName": "CSL Behring AG",
"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": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090106",
"SamplePackage": "N",
"IndicationAndUsage": "The definitive treatment of major hemorrhage is the transfusion of red blood cells restoring a normal oxygen transport capacity of the blood. Since, however, the life-threatening event in major hemorrhage is the loss of blood volume and not the erythrocyte deficit, the blood volume can, as an emergency measure, be supported by ALBURX® 5, Albumin (Human) 5% solution or another rapidly acting plasma substitute if blood is not immediately available. This will restore cardiac output and abolish circulatory failure with tissue anoxia. Though a four- to fivefold volume of crystalloids may be equally effective, their administration takes more time and creates a general overload with sodium and water. In the presence of dehydration, electrolyte solutions such as Ringer's lactate should be administered in conjunction with albumin.",
"Description": "ALBURX® 5, Albumin (Human) 5% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. The solution is clear and slightly viscous; it is almost colorless, or yellow, amber, or green. This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 0.14 M (3.2 mg/mL) sodium. The aluminum content is ≤ 200 mcg/L and the potassium content is ≤ 0.002 M. The solution is stabilized with 0.004 M sodium N-acetyltryptophanate and 0.004 M sodium caprylate. The solution contains no preservative."
},
{
"NDCCode": "44206-416-03",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (44206-416-03) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (44206-416-90)",
"NDC11Code": "44206-0416-03",
"ProductNDC": "44206-416",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Carimune",
"ProprietaryNameSuffix": "Nanofiltered",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090210",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102367",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "3",
"StrengthUnit": "g/1",
"Pharm_Classes": "Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "44206-451-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (44206-451-01) / 5 mL in 1 VIAL, SINGLE-DOSE (44206-451-90) ",
"NDC11Code": "44206-0451-01",
"ProductNDC": "44206-451",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hizentra",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "LIQUID",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20111003",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125350",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": ".2",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111003",
"SamplePackage": "N",
"IndicationAndUsage": "HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.",
"Description": "HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF)."
},
{
"NDCCode": "44206-452-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (44206-452-02) / 10 mL in 1 VIAL, SINGLE-DOSE (44206-452-91) ",
"NDC11Code": "44206-0452-02",
"ProductNDC": "44206-452",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hizentra",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "LIQUID",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20111003",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125350",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": ".2",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111003",
"SamplePackage": "N",
"IndicationAndUsage": "HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.",
"Description": "HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF)."
},
{
"NDCCode": "44206-454-04",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (44206-454-04) / 20 mL in 1 VIAL, SINGLE-DOSE (44206-454-92) ",
"NDC11Code": "44206-0454-04",
"ProductNDC": "44206-454",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hizentra",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "LIQUID",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20111003",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125350",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": ".2",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111003",
"SamplePackage": "N",
"IndicationAndUsage": "HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.",
"Description": "HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF)."
},
{
"NDCCode": "44206-455-10",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (44206-455-10) / 50 mL in 1 VIAL, SINGLE-DOSE (44206-455-93) ",
"NDC11Code": "44206-0455-10",
"ProductNDC": "44206-455",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hizentra",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "LIQUID",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20111003",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125350",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": ".2",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111003",
"SamplePackage": "N",
"IndicationAndUsage": "HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.",
"Description": "HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF)."
},
{
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"PackageDescription": "1 SYRINGE in 1 CARTON (44206-455-25) / 50 mL in 1 SYRINGE (44206-455-97) ",
"NDC11Code": "44206-0455-25",
"ProductNDC": "44206-455",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hizentra",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "LIQUID",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20111003",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125350",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": ".2",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.",
"Description": "HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF)."
},
{
"NDCCode": "44206-456-21",
"PackageDescription": "1 SYRINGE in 1 CARTON (44206-456-21) / 5 mL in 1 SYRINGE (44206-456-94) ",
"NDC11Code": "44206-0456-21",
"ProductNDC": "44206-456",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hizentra",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "LIQUID",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125350",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": ".2",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2023-05-03",
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"IndicationAndUsage": "HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.",
"Description": "HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF)."
},
{
"NDCCode": "44206-457-22",
"PackageDescription": "1 SYRINGE in 1 CARTON (44206-457-22) / 10 mL in 1 SYRINGE (44206-457-95) ",
"NDC11Code": "44206-0457-22",
"ProductNDC": "44206-457",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hizentra",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "LIQUID",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125350",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": ".2",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.",
"Description": "HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF)."
},
{
"NDCCode": "44206-458-24",
"PackageDescription": "1 SYRINGE in 1 CARTON (44206-458-24) / 20 mL in 1 SYRINGE (44206-458-96) ",
"NDC11Code": "44206-0458-24",
"ProductNDC": "44206-458",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hizentra",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "LIQUID",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125350",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": ".2",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.",
"Description": "HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF)."
},
{
"NDCCode": "0054-0293-99",
"PackageDescription": "1 BOTTLE in 1 CARTON (0054-0293-99) > 200 SPRAY, METERED in 1 BOTTLE",
"NDC11Code": "00054-0293-99",
"ProductNDC": "0054-0293",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azelastine Hydrochloride",
"NonProprietaryName": "Azelastine Hydrochloride",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20141027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091444",
"LabelerName": "West-Ward Pharmaceuticals Corp.",
"SubstanceName": "AZELASTINE HYDROCHLORIDE",
"StrengthNumber": "137",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20141027",
"SamplePackage": "N",
"IndicationAndUsage": "Azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.",
"Description": "Azelastine Hydrochloride Nasal Spray 137 micrograms (mcg), is an antihistamine formulated as a metered-spray for intranasal administration. Azelastine hydrochloride occurs as a white to almost white solid. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerine. It has a melting point of about 225°C and the pH of a saturated solution is between 5.0 and 5.4. Its chemical name is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C22H24ClN3O·HCl with the following chemical structure. Azelastine Hydrochloride Nasal Spray contains 0.1% azelastine hydrochloride in an aqueous solution at pH 6.8 ± 0.3. It also contains benzalkonium chloride, citric acid anhydrous, dibasic sodium phosphate dodecahydrate, edetate disodium, hypromellose, purified water and sodium chloride. After priming [see Dosage and Administration (2.3)], each metered spray delivers a 0.137 mL mean volume containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base). The bottle can deliver 200 metered sprays."
},
{
"NDCCode": "0069-2377-10",
"PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (0069-2377-10) / .418 mL in 1 SYRINGE, GLASS (0069-2377-01) ",
"NDC11Code": "00069-2377-10",
"ProductNDC": "0069-2377",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Comirnaty",
"NonProprietaryName": "Covid-19 Vaccine, Mrna",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20231031",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125742",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "RAXTOZINAMERAN",
"StrengthNumber": ".042",
"StrengthUnit": "mg/.418mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20231031",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.",
"Description": "COMIRNATY (COVID-19 Vaccine, mRNA) is a sterile suspension for injection for intramuscular use. Each 0.3 mL dose of COMIRNATY (2024-2025 Formula) is formulated to contain 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant lineage KP.2. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. COMIRNATY does not contain preservatives. The vial stoppers are not made with natural rubber latex. The prefilled syringe tip cap and plunger stopper are not made with natural rubber latex."
}
]
}
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<NDCList>
<NDC>
<NDCCode>44206-418-12</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (44206-418-12) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (44206-418-92) </PackageDescription>
<NDC11Code>44206-0418-12</NDC11Code>
<ProductNDC>44206-418</ProductNDC>
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<EndMarketingDate>20210531</EndMarketingDate>
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<LabelerName>CSL Behring AG</LabelerName>
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<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-06-02</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090210</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>12634-418-52</NDCCode>
<PackageDescription>12 TABLET in 1 BLISTER PACK (12634-418-52)</PackageDescription>
<NDC11Code>12634-0418-52</NDC11Code>
<ProductNDC>12634-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091179</ApplicationNumber>
<LabelerName>Apotheca, Inc</LabelerName>
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<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Promethazine hydrochloride tablets are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled. Preoperative, postoperative and obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Sedation in both children and adults as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Promethazine Hydrochloride, a phenothiazine derivative, is designated chemically as 10- [2-(Dimethylamino)propyl]phenothiazine monohydochloride and has the following structural formula. Promethazine hydrochloride is a racemic compound; the empirical formula is C17H20N2S HCl and its molecular weight is 320.88.Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg promethazine hydrochloride, USP. The inactive ingredients include: lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The 50 mg also contains D&C Red # 27 Lake.</Description>
</NDC>
<NDC>
<NDCCode>12634-418-82</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE (12634-418-82)</PackageDescription>
<NDC11Code>12634-0418-82</NDC11Code>
<ProductNDC>12634-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091179</ApplicationNumber>
<LabelerName>Apotheca, Inc</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Promethazine hydrochloride tablets are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled. Preoperative, postoperative and obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Sedation in both children and adults as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Promethazine Hydrochloride, a phenothiazine derivative, is designated chemically as 10- [2-(Dimethylamino)propyl]phenothiazine monohydochloride and has the following structural formula. Promethazine hydrochloride is a racemic compound; the empirical formula is C17H20N2S HCl and its molecular weight is 320.88.Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg promethazine hydrochloride, USP. The inactive ingredients include: lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The 50 mg also contains D&C Red # 27 Lake.</Description>
</NDC>
<NDC>
<NDCCode>16729-418-12</NDCCode>
<PackageDescription>1 KIT in 1 KIT (16729-418-12) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-416-54) * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-417-46) </PackageDescription>
<NDC11Code>16729-0418-12</NDC11Code>
<ProductNDC>16729-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20220926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210499</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl fumarate delayed-release capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C 6H 8O 4). It has the following structure:. Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: silicified microcrystalline cellulose, croscarmellose sodium, talc, colloidal anhydrous silica, magnesium stearate, triethyl citrate, methacrylic acid copolymer, methacrylic acid - methyl methacrylate copolymer (1:1). The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, titanium dioxide, FD&C blue 1, iron oxide black, iron oxide yellow, shellac, propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>33342-418-12</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-418-12) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0418-12</NDC11Code>
<ProductNDC>33342-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212987</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
<Description>Potassium chloride extended-release tablets are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium chloride extended-release tablets are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, colorless crystals or a white crystalline powder. It is odorless with a salty taste, freely soluble in water, practically insoluble in ethanol. Inactive Ingredients: Hydrogenated vegetable oil, colloidal-silicon-dioxide, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP. FDA approved acceptance criteria for assay differs from USP test.</Description>
</NDC>
<NDC>
<NDCCode>46122-418-62</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (46122-418-62) / 12 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>46122-0418-62</NDC11Code>
<ProductNDC>46122-418</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold Flu Severe</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>AmeriSource Bergen</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of the following cold/flu symptoms: minor aches and painsheadachesore throatnasal congestioncough. helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63517-418-16</NDCCode>
<PackageDescription>12 BOTTLE, PUMP in 1 CASE (63517-418-16) > 473 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>63517-0418-16</NDC11Code>
<ProductNDC>63517-418</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cardinal Health Antimicrobial Soap With Triclosan</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110314</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.003</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64980-418-12</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (64980-418-12) </PackageDescription>
<NDC11Code>64980-0418-12</NDC11Code>
<ProductNDC>64980-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208371</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains 250 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 3.57 and is practically insoluble in water. The pKa at about 25°C is 3.06. Abiraterone acetate Tablets, USP are available in 250 mg uncoated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>68428-418-12</NDCCode>
<PackageDescription>600 PELLET in 1 BOTTLE, GLASS (68428-418-12) </PackageDescription>
<NDC11Code>68428-0418-12</NDC11Code>
<ProductNDC>68428-418</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hamamelis Virginiana</ProprietaryName>
<NonProprietaryName>Hamamelis Virginiana Root Bark/stem Bark</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications. HAMAMELIS Varicose veins.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69168-013-15</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (69168-013-15) * 2 BLISTER PACK in 1 CARTON (69168-474-93) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (69168-418-86) / 12 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69168-0013-15</NDC11Code>
<ProductNDC>69168-013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daytime And Nighttime Cold And Flu Kit</ProprietaryName>
<NonProprietaryName>Daytime And Nighttime Cold And Flu Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260306</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Allegiant Health</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DAYTIME ONLY. temporarily relieves these symptoms due to a cold or flu: 1 cough , 2 sore throat , 3 headache, 4 minor aches and pains , 5 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69168-438-15</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (69168-438-15) * 2 BLISTER PACK in 1 CARTON (69168-417-93) / 12 CAPSULE in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (69168-418-86) / 12 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69168-0438-15</NDC11Code>
<ProductNDC>69168-438</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daytime Nighttime Cold And Flu Relief Combo Pack</ProprietaryName>
<NonProprietaryName>Daytime Nighttime Cold And Flu</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20220520</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Allegiant Health</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DAYTIME ONLY. temporarily relieves common cold/flu symptoms: nasalcongestion cough due to minor throat & bronchial irritation sorethroat headache minor aches & pains fever. NIGHTTIME ONLY. temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79903-418-24</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (79903-418-24) / 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>79903-0418-24</NDC11Code>
<ProductNDC>79903-418</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Nighttime Vapor Ice Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260708</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>WALMART INC.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>325; 10; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260708</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms:cough due to minor throat and bronchial irritationcough to help you sleepsore throatheadacheminor aches and painsfeverrunny nose and sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85828-418-93</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (85828-418-93) / 12 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>85828-0418-93</NDC11Code>
<ProductNDC>85828-418</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighttime Cold And Flu Relief</ProprietaryName>
<NonProprietaryName>Nighttime Cold And Flu Relief</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260325</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Grocery Outlet</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>325; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold and flu symptoms: 1 cough due to minor throat and bronchial irritation, 2 sore throat, 3 headache, 4 minor aches and pains, 5 fever, 6 runny nose and sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>44206-251-05</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (44206-251-05) > 50 mL in 1 VIAL, GLASS (44206-251-90) </PackageDescription>
<NDC11Code>44206-0251-05</NDC11Code>
<ProductNDC>44206-251</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Alburx</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090106</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102366</ApplicationNumber>
<LabelerName>CSL Behring AG</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>2022-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>ALBURX® 25, Albumin (Human) 25% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. The solution is clear and slightly viscous; it is almost colorless, or yellow, amber, or green. This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 0.14 M (3.2 mg/mL) sodium. The aluminum content is ≤ 200 mcg/L and the potassium content is ≤ 0.002 M. The solution is stabilized with 0.02 M sodium N-acetyltryptophanate and 0.02 M sodium caprylate. The solution contains no preservative.</Description>
</NDC>
<NDC>
<NDCCode>44206-251-10</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (44206-251-10) > 100 mL in 1 VIAL, GLASS (44206-251-91) </PackageDescription>
<NDC11Code>44206-0251-10</NDC11Code>
<ProductNDC>44206-251</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Alburx</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090106</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102366</ApplicationNumber>
<LabelerName>CSL Behring AG</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>2022-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>ALBURX® 25, Albumin (Human) 25% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. The solution is clear and slightly viscous; it is almost colorless, or yellow, amber, or green. This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 0.14 M (3.2 mg/mL) sodium. The aluminum content is ≤ 200 mcg/L and the potassium content is ≤ 0.002 M. The solution is stabilized with 0.02 M sodium N-acetyltryptophanate and 0.02 M sodium caprylate. The solution contains no preservative.</Description>
</NDC>
<NDC>
<NDCCode>44206-300-01</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (44206-300-01) / 2 mL in 1 SYRINGE, GLASS (44206-300-90) </PackageDescription>
<NDC11Code>44206-0300-01</NDC11Code>
<ProductNDC>44206-300</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Rhophylac</ProprietaryName>
<NonProprietaryName>Human Rho(d) Immune Globulin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20090106</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125070</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN RHO(D) IMMUNE GLOBULIN</SubstanceName>
<StrengthNumber>1500</StrengthNumber>
<StrengthUnit>[iU]/2mL</StrengthUnit>
<Pharm_Classes>Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RHOPHYLAC is a Rh(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the suppression of Rh isoimmunization in non-sensitized Rh(D)-negative patients and for the treatment of immune thrombocytopenic purpura (ITP) in Rh(D)-positive patients.</IndicationAndUsage>
<Description>RHOPHYLAC is a sterile Rh(D) Immune Globulin Intravenous (Human) (anti-D) solution in a ready-to-use prefilled glass syringe for intravenous or intramuscular injection. One syringe contains at least 1500 IU (300 mcg) of IgG antibodies to Rh(D) in a 2 mL solution, sufficient to suppress the immune response to at least 15 mL of Rh(D)-positive RBCs.1 The product potency is expressed in IUs by comparison to the World Health Organization (WHO) standard, which is also the US and the European Pharmacopoeia standard. Plasma is obtained from healthy Rh(D)-negative donors who have been immunized with Rh(D)-positive RBCs. The donors are screened carefully to reduce the risk of receiving donations containing blood-borne pathogens. Each plasma donation used in the manufacture of RHOPHYLAC is tested for the presence of HBV surface antigen (HBsAg), HIV-1/2, and HCV antibodies. In addition, plasma used in the manufacture of RHOPHYLAC is tested by FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV, and HIV-1 and found to be negative. The source plasma is also tested by NAT for hepatitis A virus (HAV) and B19 virus (B19V). RHOPHYLAC is produced by an ion-exchange chromatography isolation procedure5, using pooled plasma obtained by plasmapheresis of immunized Rh(D)-negative US donors. The manufacturing process of RHOPHYLAC includes two dedicated virus reduction steps (i.e., solvent/detergent treatment and virus filtration with a Planova® 15 nanometer (nm) virus filter) as well as one ion exchange chromatography step contributing to virus reduction.6,7 All three virus reduction steps have been independently validated in a series of in vitro experiments for their capacity to inactivate or remove enveloped and/or non-enveloped viruses. Virus models were chosen to cover a broad selection of viruses, including the major blood-transmissible viruses like human immunodeficiency virus, hepatitis B and hepatitis C virus, as well as small, non-enveloped viruses like hepatitis A virus and human parvovirus B19. Viral clearance data from validation studies of the dedicated virus reduction steps for both enveloped and nonenveloped viruses will be provided upon request by calling 1-800-504-5434. Overall virus reduction expressed as mean log10 reduction factor of model enveloped and non-enveloped viruses has been shown to be ≥11 log10 and ≥9 log10 respectively. RHOPHYLAC contains a maximum of 30 mg/mL of human plasma proteins, 10 mg/mL of which is human albumin added as a stabilizer. Prior to the addition of the stabilizer, RHOPHYLAC has a purity greater than 95% IgG. RHOPHYLAC contains less than 5 mcg/mL of IgA, which is the limit of detection. Additional excipients are approximately 20 mg/mL of glycine and up to 0.25 M of sodium chloride. RHOPHYLAC contains no preservative. Human albumin is manufactured from pooled plasma of US donors by cold ethanol fractionation, followed by pasteurization.</Description>
</NDC>
<NDC>
<NDCCode>44206-300-10</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 CARTON (44206-300-10) / 2 mL in 1 SYRINGE, GLASS (44206-300-90) </PackageDescription>
<NDC11Code>44206-0300-10</NDC11Code>
<ProductNDC>44206-300</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Rhophylac</ProprietaryName>
<NonProprietaryName>Human Rho(d) Immune Globulin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20090106</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125070</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN RHO(D) IMMUNE GLOBULIN</SubstanceName>
<StrengthNumber>1500</StrengthNumber>
<StrengthUnit>[iU]/2mL</StrengthUnit>
<Pharm_Classes>Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RHOPHYLAC is a Rh(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the suppression of Rh isoimmunization in non-sensitized Rh(D)-negative patients and for the treatment of immune thrombocytopenic purpura (ITP) in Rh(D)-positive patients.</IndicationAndUsage>
<Description>RHOPHYLAC is a sterile Rh(D) Immune Globulin Intravenous (Human) (anti-D) solution in a ready-to-use prefilled glass syringe for intravenous or intramuscular injection. One syringe contains at least 1500 IU (300 mcg) of IgG antibodies to Rh(D) in a 2 mL solution, sufficient to suppress the immune response to at least 15 mL of Rh(D)-positive RBCs.1 The product potency is expressed in IUs by comparison to the World Health Organization (WHO) standard, which is also the US and the European Pharmacopoeia standard. Plasma is obtained from healthy Rh(D)-negative donors who have been immunized with Rh(D)-positive RBCs. The donors are screened carefully to reduce the risk of receiving donations containing blood-borne pathogens. Each plasma donation used in the manufacture of RHOPHYLAC is tested for the presence of HBV surface antigen (HBsAg), HIV-1/2, and HCV antibodies. In addition, plasma used in the manufacture of RHOPHYLAC is tested by FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV, and HIV-1 and found to be negative. The source plasma is also tested by NAT for hepatitis A virus (HAV) and B19 virus (B19V). RHOPHYLAC is produced by an ion-exchange chromatography isolation procedure5, using pooled plasma obtained by plasmapheresis of immunized Rh(D)-negative US donors. The manufacturing process of RHOPHYLAC includes two dedicated virus reduction steps (i.e., solvent/detergent treatment and virus filtration with a Planova® 15 nanometer (nm) virus filter) as well as one ion exchange chromatography step contributing to virus reduction.6,7 All three virus reduction steps have been independently validated in a series of in vitro experiments for their capacity to inactivate or remove enveloped and/or non-enveloped viruses. Virus models were chosen to cover a broad selection of viruses, including the major blood-transmissible viruses like human immunodeficiency virus, hepatitis B and hepatitis C virus, as well as small, non-enveloped viruses like hepatitis A virus and human parvovirus B19. Viral clearance data from validation studies of the dedicated virus reduction steps for both enveloped and nonenveloped viruses will be provided upon request by calling 1-800-504-5434. Overall virus reduction expressed as mean log10 reduction factor of model enveloped and non-enveloped viruses has been shown to be ≥11 log10 and ≥9 log10 respectively. RHOPHYLAC contains a maximum of 30 mg/mL of human plasma proteins, 10 mg/mL of which is human albumin added as a stabilizer. Prior to the addition of the stabilizer, RHOPHYLAC has a purity greater than 95% IgG. RHOPHYLAC contains less than 5 mcg/mL of IgA, which is the limit of detection. Additional excipients are approximately 20 mg/mL of glycine and up to 0.25 M of sodium chloride. RHOPHYLAC contains no preservative. Human albumin is manufactured from pooled plasma of US donors by cold ethanol fractionation, followed by pasteurization.</Description>
</NDC>
<NDC>
<NDCCode>44206-310-25</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (44206-310-25) / 250 mL in 1 VIAL, GLASS (44206-310-90) </PackageDescription>
<NDC11Code>44206-0310-25</NDC11Code>
<ProductNDC>44206-310</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Alburx</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090106</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102366</ApplicationNumber>
<LabelerName>CSL Behring AG</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>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The definitive treatment of major hemorrhage is the transfusion of red blood cells restoring a normal oxygen transport capacity of the blood. Since, however, the life-threatening event in major hemorrhage is the loss of blood volume and not the erythrocyte deficit, the blood volume can, as an emergency measure, be supported by ALBURX® 5, Albumin (Human) 5% solution or another rapidly acting plasma substitute if blood is not immediately available. This will restore cardiac output and abolish circulatory failure with tissue anoxia. Though a four- to fivefold volume of crystalloids may be equally effective, their administration takes more time and creates a general overload with sodium and water. In the presence of dehydration, electrolyte solutions such as Ringer's lactate should be administered in conjunction with albumin.</IndicationAndUsage>
<Description>ALBURX® 5, Albumin (Human) 5% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. The solution is clear and slightly viscous; it is almost colorless, or yellow, amber, or green. This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 0.14 M (3.2 mg/mL) sodium. The aluminum content is ≤ 200 mcg/L and the potassium content is ≤ 0.002 M. The solution is stabilized with 0.004 M sodium N-acetyltryptophanate and 0.004 M sodium caprylate. The solution contains no preservative.</Description>
</NDC>
<NDC>
<NDCCode>44206-310-50</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (44206-310-50) / 500 mL in 1 VIAL, GLASS (44206-310-91) </PackageDescription>
<NDC11Code>44206-0310-50</NDC11Code>
<ProductNDC>44206-310</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Alburx</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090106</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102366</ApplicationNumber>
<LabelerName>CSL Behring AG</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>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The definitive treatment of major hemorrhage is the transfusion of red blood cells restoring a normal oxygen transport capacity of the blood. Since, however, the life-threatening event in major hemorrhage is the loss of blood volume and not the erythrocyte deficit, the blood volume can, as an emergency measure, be supported by ALBURX® 5, Albumin (Human) 5% solution or another rapidly acting plasma substitute if blood is not immediately available. This will restore cardiac output and abolish circulatory failure with tissue anoxia. Though a four- to fivefold volume of crystalloids may be equally effective, their administration takes more time and creates a general overload with sodium and water. In the presence of dehydration, electrolyte solutions such as Ringer's lactate should be administered in conjunction with albumin.</IndicationAndUsage>
<Description>ALBURX® 5, Albumin (Human) 5% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. The solution is clear and slightly viscous; it is almost colorless, or yellow, amber, or green. This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 0.14 M (3.2 mg/mL) sodium. The aluminum content is ≤ 200 mcg/L and the potassium content is ≤ 0.002 M. The solution is stabilized with 0.004 M sodium N-acetyltryptophanate and 0.004 M sodium caprylate. The solution contains no preservative.</Description>
</NDC>
<NDC>
<NDCCode>44206-416-03</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (44206-416-03) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (44206-416-90)</PackageDescription>
<NDC11Code>44206-0416-03</NDC11Code>
<ProductNDC>44206-416</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Carimune</ProprietaryName>
<ProprietaryNameSuffix>Nanofiltered</ProprietaryNameSuffix>
<NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090210</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102367</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>44206-451-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (44206-451-01) / 5 mL in 1 VIAL, SINGLE-DOSE (44206-451-90) </PackageDescription>
<NDC11Code>44206-0451-01</NDC11Code>
<ProductNDC>44206-451</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Hizentra</ProprietaryName>
<NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111003</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125350</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.</IndicationAndUsage>
<Description>HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF).</Description>
</NDC>
<NDC>
<NDCCode>44206-452-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (44206-452-02) / 10 mL in 1 VIAL, SINGLE-DOSE (44206-452-91) </PackageDescription>
<NDC11Code>44206-0452-02</NDC11Code>
<ProductNDC>44206-452</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Hizentra</ProprietaryName>
<NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111003</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125350</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.</IndicationAndUsage>
<Description>HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF).</Description>
</NDC>
<NDC>
<NDCCode>44206-454-04</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (44206-454-04) / 20 mL in 1 VIAL, SINGLE-DOSE (44206-454-92) </PackageDescription>
<NDC11Code>44206-0454-04</NDC11Code>
<ProductNDC>44206-454</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Hizentra</ProprietaryName>
<NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111003</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125350</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.</IndicationAndUsage>
<Description>HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF).</Description>
</NDC>
<NDC>
<NDCCode>44206-455-10</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (44206-455-10) / 50 mL in 1 VIAL, SINGLE-DOSE (44206-455-93) </PackageDescription>
<NDC11Code>44206-0455-10</NDC11Code>
<ProductNDC>44206-455</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Hizentra</ProprietaryName>
<NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111003</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125350</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.</IndicationAndUsage>
<Description>HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF).</Description>
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<PackageDescription>1 SYRINGE in 1 CARTON (44206-455-25) / 50 mL in 1 SYRINGE (44206-455-97) </PackageDescription>
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<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
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<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125350</ApplicationNumber>
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<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
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<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-03</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.</IndicationAndUsage>
<Description>HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF).</Description>
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<NDCCode>44206-456-21</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (44206-456-21) / 5 mL in 1 SYRINGE (44206-456-94) </PackageDescription>
<NDC11Code>44206-0456-21</NDC11Code>
<ProductNDC>44206-456</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Hizentra</ProprietaryName>
<NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125350</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.</IndicationAndUsage>
<Description>HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF).</Description>
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<NDC>
<NDCCode>44206-457-22</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (44206-457-22) / 10 mL in 1 SYRINGE (44206-457-95) </PackageDescription>
<NDC11Code>44206-0457-22</NDC11Code>
<ProductNDC>44206-457</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Hizentra</ProprietaryName>
<NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125350</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.</IndicationAndUsage>
<Description>HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF).</Description>
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<NDC>
<NDCCode>44206-458-24</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (44206-458-24) / 20 mL in 1 SYRINGE (44206-458-96) </PackageDescription>
<NDC11Code>44206-0458-24</NDC11Code>
<ProductNDC>44206-458</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Hizentra</ProprietaryName>
<NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125350</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.</IndicationAndUsage>
<Description>HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF).</Description>
</NDC>
<NDC>
<NDCCode>0054-0293-99</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0054-0293-99) > 200 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>00054-0293-99</NDC11Code>
<ProductNDC>0054-0293</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azelastine Hydrochloride</ProprietaryName>
<NonProprietaryName>Azelastine Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20141027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091444</ApplicationNumber>
<LabelerName>West-Ward Pharmaceuticals Corp.</LabelerName>
<SubstanceName>AZELASTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>137</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-17</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.</IndicationAndUsage>
<Description>Azelastine Hydrochloride Nasal Spray 137 micrograms (mcg), is an antihistamine formulated as a metered-spray for intranasal administration. Azelastine hydrochloride occurs as a white to almost white solid. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerine. It has a melting point of about 225°C and the pH of a saturated solution is between 5.0 and 5.4. Its chemical name is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C22H24ClN3O·HCl with the following chemical structure. Azelastine Hydrochloride Nasal Spray contains 0.1% azelastine hydrochloride in an aqueous solution at pH 6.8 ± 0.3. It also contains benzalkonium chloride, citric acid anhydrous, dibasic sodium phosphate dodecahydrate, edetate disodium, hypromellose, purified water and sodium chloride. After priming [see Dosage and Administration (2.3)], each metered spray delivers a 0.137 mL mean volume containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base). The bottle can deliver 200 metered sprays.</Description>
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<NDC>
<NDCCode>0069-2377-10</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 CARTON (0069-2377-10) / .418 mL in 1 SYRINGE, GLASS (0069-2377-01) </PackageDescription>
<NDC11Code>00069-2377-10</NDC11Code>
<ProductNDC>0069-2377</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Comirnaty</ProprietaryName>
<NonProprietaryName>Covid-19 Vaccine, Mrna</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20231031</StartMarketingDate>
<EndMarketingDate>20240831</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125742</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>RAXTOZINAMERAN</SubstanceName>
<StrengthNumber>.042</StrengthNumber>
<StrengthUnit>mg/.418mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20231031</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.</IndicationAndUsage>
<Description>COMIRNATY (COVID-19 Vaccine, mRNA) is a sterile suspension for injection for intramuscular use. Each 0.3 mL dose of COMIRNATY (2024-2025 Formula) is formulated to contain 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant lineage KP.2. Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. COMIRNATY does not contain preservatives. The vial stoppers are not made with natural rubber latex. The prefilled syringe tip cap and plunger stopper are not made with natural rubber latex.</Description>
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