{
"NDC": [
{
"NDCCode": "0944-2884-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0944-2884-01) / 50 mL in 1 VIAL, GLASS (0944-2884-02) ",
"NDC11Code": "00944-2884-01",
"ProductNDC": "0944-2884",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Glassia",
"NonProprietaryName": "Alpha.1-proteinase Inhibitor Human",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125325",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": ".ALPHA.1-PROTEINASE INHIBITOR HUMAN",
"StrengthNumber": "1",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human alpha-1 Proteinase Inhibitor [EPC], Trypsin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100701",
"SamplePackage": "N",
"IndicationAndUsage": "GLASSIA is an Alpha1-Proteinase Inhibitor (Human), indicated for chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe hereditary deficiency of Alpha1-PI, also known as alpha1-antitrypsin (AAT) deficiency. Limitations of Use: 1 The effect of augmentation therapy with GLASSIA or any Alpha1-PI product on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials., 2 Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available., 3 GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.",
"Description": "GLASSIA is a sterile, ready to use, liquid preparation of purified human Alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT). The solution contains 2% active Alpha1-PI in a phosphate-buffered saline solution. The specific activity of GLASSIA is ≥ 0.7 mg functional Alpha1-PI per mg of total protein. Not less than 90% of the Alpha1-PI in GLASSIA is of the monomeric form as measured by size-exclusion chromatography. GLASSIA is prepared from human plasma obtained from US-licensed plasma collection centers by a modified version of the cold ethanol fractionation process and the Alpha1-PI is then purified using chromatographic methods. Individual plasma units used for production of GLASSIA are tested using FDA- licensed serological assays for hepatitis B surface antigen (HBsAg) and for antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 (HIV-1/2), as well as by FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1. Each plasma unit must be non-reactive (negative) in all tests. Plasma is also tested by in-process NAT procedures for parvovirus B19 and the limit for B19 DNA in the manufacturing pool is set not to exceed 104 IU per mL. To reduce the risk of viral transmission, the manufacturing process for GLASSIA includes two steps specifically designed to remove or inactivate viruses. The first of these is nanofiltration (NF) through a 15 nm filter which can remove both enveloped and non–enveloped viral agents and the second is solvent/detergent (S/D) treatment with a mixture of tri-(n-butyl) phosphate (TNBP) and Polysorbate 80 (Tween 80) which inactivates enveloped viral agents such as HIV, HBV and HCV. The effectiveness of the S/D treatment and nanofiltration procedures for reducing virus content has been assessed using a series of viruses with a range of physico-chemical characteristics. The results of the viral challenge studies are summarized in Table 4."
},
{
"NDCCode": "0944-2884-03",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0944-2884-03) / 200 mL in 1 VIAL, GLASS (0944-2884-04) ",
"NDC11Code": "00944-2884-03",
"ProductNDC": "0944-2884",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Glassia",
"NonProprietaryName": "Alpha.1-proteinase Inhibitor Human",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125325",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": ".ALPHA.1-PROTEINASE INHIBITOR HUMAN",
"StrengthNumber": "1",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human alpha-1 Proteinase Inhibitor [EPC], Trypsin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100701",
"SamplePackage": "N",
"IndicationAndUsage": "GLASSIA is an Alpha1-Proteinase Inhibitor (Human), indicated for chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe hereditary deficiency of Alpha1-PI, also known as alpha1-antitrypsin (AAT) deficiency. Limitations of Use: 1 The effect of augmentation therapy with GLASSIA or any Alpha1-PI product on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials., 2 Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available., 3 GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.",
"Description": "GLASSIA is a sterile, ready to use, liquid preparation of purified human Alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT). The solution contains 2% active Alpha1-PI in a phosphate-buffered saline solution. The specific activity of GLASSIA is ≥ 0.7 mg functional Alpha1-PI per mg of total protein. Not less than 90% of the Alpha1-PI in GLASSIA is of the monomeric form as measured by size-exclusion chromatography. GLASSIA is prepared from human plasma obtained from US-licensed plasma collection centers by a modified version of the cold ethanol fractionation process and the Alpha1-PI is then purified using chromatographic methods. Individual plasma units used for production of GLASSIA are tested using FDA- licensed serological assays for hepatitis B surface antigen (HBsAg) and for antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 (HIV-1/2), as well as by FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1. Each plasma unit must be non-reactive (negative) in all tests. Plasma is also tested by in-process NAT procedures for parvovirus B19 and the limit for B19 DNA in the manufacturing pool is set not to exceed 104 IU per mL. To reduce the risk of viral transmission, the manufacturing process for GLASSIA includes two steps specifically designed to remove or inactivate viruses. The first of these is nanofiltration (NF) through a 15 nm filter which can remove both enveloped and non–enveloped viral agents and the second is solvent/detergent (S/D) treatment with a mixture of tri-(n-butyl) phosphate (TNBP) and Polysorbate 80 (Tween 80) which inactivates enveloped viral agents such as HIV, HBV and HCV. The effectiveness of the S/D treatment and nanofiltration procedures for reducing virus content has been assessed using a series of viruses with a range of physico-chemical characteristics. The results of the viral challenge studies are summarized in Table 4."
},
{
"NDCCode": "0944-2884-05",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0944-2884-05) / 250 mL in 1 VIAL, GLASS (0944-2884-06) ",
"NDC11Code": "00944-2884-05",
"ProductNDC": "0944-2884",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Glassia",
"NonProprietaryName": "Alpha.1-proteinase Inhibitor Human",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125325",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": ".ALPHA.1-PROTEINASE INHIBITOR HUMAN",
"StrengthNumber": "1",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human alpha-1 Proteinase Inhibitor [EPC], Trypsin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100701",
"SamplePackage": "N",
"IndicationAndUsage": "GLASSIA is an Alpha1-Proteinase Inhibitor (Human), indicated for chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe hereditary deficiency of Alpha1-PI, also known as alpha1-antitrypsin (AAT) deficiency. Limitations of Use: 1 The effect of augmentation therapy with GLASSIA or any Alpha1-PI product on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials., 2 Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available., 3 GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.",
"Description": "GLASSIA is a sterile, ready to use, liquid preparation of purified human Alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT). The solution contains 2% active Alpha1-PI in a phosphate-buffered saline solution. The specific activity of GLASSIA is ≥ 0.7 mg functional Alpha1-PI per mg of total protein. Not less than 90% of the Alpha1-PI in GLASSIA is of the monomeric form as measured by size-exclusion chromatography. GLASSIA is prepared from human plasma obtained from US-licensed plasma collection centers by a modified version of the cold ethanol fractionation process and the Alpha1-PI is then purified using chromatographic methods. Individual plasma units used for production of GLASSIA are tested using FDA- licensed serological assays for hepatitis B surface antigen (HBsAg) and for antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 (HIV-1/2), as well as by FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1. Each plasma unit must be non-reactive (negative) in all tests. Plasma is also tested by in-process NAT procedures for parvovirus B19 and the limit for B19 DNA in the manufacturing pool is set not to exceed 104 IU per mL. To reduce the risk of viral transmission, the manufacturing process for GLASSIA includes two steps specifically designed to remove or inactivate viruses. The first of these is nanofiltration (NF) through a 15 nm filter which can remove both enveloped and non–enveloped viral agents and the second is solvent/detergent (S/D) treatment with a mixture of tri-(n-butyl) phosphate (TNBP) and Polysorbate 80 (Tween 80) which inactivates enveloped viral agents such as HIV, HBV and HCV. The effectiveness of the S/D treatment and nanofiltration procedures for reducing virus content has been assessed using a series of viruses with a range of physico-chemical characteristics. The results of the viral challenge studies are summarized in Table 4."
},
{
"NDCCode": "0591-2884-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0591-2884-01) ",
"NDC11Code": "00591-2884-01",
"ProductNDC": "0591-2884",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "19900529",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019614",
"LabelerName": "Teva Pharmaceuticals Inc",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19900529",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil hydrochloride sustained-release capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.",
"Description": "Verapamil hydrochloride sustained-release capsules are calcium ion influx inhibitors (slow channel blockers or calcium ion antagonists). Verapamil hydrochloride sustained-release capsules are available for oral administration as a 360 mg hard gelatin capsule (lavender cap/yellow body), a 240 mg hard gelatin capsule (dark blue cap/yellow body), a 180 mg hard gelatin capsule (light grey cap/yellow body), and a 120 mg hard gelatin capsule (yellow cap/yellow body). These pellet-filled capsules provide a sustained-release of the drug in the gastrointestinal tract. The structural formula of verapamil HCl is given below. C27H38N2O4HCl M.W. 491.07. Chemical name: Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) monohydrochloride. Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not structurally related to other cardioactive drugs. In addition to verapamil HCl the verapamil hydrochloride sustained-release capsules contain the following inactive ingredients: fumaric acid, talc, sugar spheres, povidone, shellac, gelatin, FD&C red #40, yellow iron oxide, titanium dioxide, methylparaben, propylparaben, silicon dioxide, and sodium lauryl sulfate. In addition, the verapamil hydrochloride sustained-release capsules 240 mg and 360 mg capsules contain FD&C blue #1 and D&C red #28; and the verapamil hydrochloride sustained-release capsules 180 mg contain black iron oxide."
},
{
"NDCCode": "36987-2884-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-2884-1)",
"NDC11Code": "36987-2884-01",
"ProductNDC": "36987-2884",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Virginia Live Oak",
"NonProprietaryName": "Virginia Live Oak",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "QUERCUS VIRGINIANA POLLEN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-2884-1",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-2884-1) ",
"NDC11Code": "37662-2884-01",
"ProductNDC": "37662-2884",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kali Aceticum",
"NonProprietaryName": "Kali Aceticum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230328",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "POTASSIUM ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/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": "2023-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230328",
"SamplePackage": "N"
},
{
"NDCCode": "50090-2884-1",
"PackageDescription": "90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (50090-2884-1) ",
"NDC11Code": "50090-2884-01",
"ProductNDC": "50090-2884",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074984",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170227",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg, 180 mg, 240 mg or 300 mg diltiazem hydrochloride. Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11."
},
{
"NDCCode": "62991-2884-1",
"PackageDescription": "1 g in 1 JAR (62991-2884-1)",
"NDC11Code": "62991-2884-01",
"ProductNDC": "62991-2884",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Glipizide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20101109",
"EndMarketingDate": "20140630",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "LETCO MEDICAL, LLC",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20140630"
},
{
"NDCCode": "63629-2884-1",
"PackageDescription": "1 TABLET in 1 BOTTLE (63629-2884-1) ",
"NDC11Code": "63629-2884-01",
"ProductNDC": "63629-2884",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diovan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021283",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20010701",
"SamplePackage": "N"
},
{
"NDCCode": "71335-2884-1",
"PackageDescription": "1 BOTTLE in 1 CARTON (71335-2884-1) / 118.28 mL in 1 BOTTLE",
"NDC11Code": "71335-2884-01",
"ProductNDC": "71335-2884",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212760",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".11",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251110",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone acetonide topical oil, 0.01% is a corticosteroid indicated for the : 1 topical treatment of atopic dermatitis in adult patients (1.1), 2 topical treatment of moderato to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks (1.2).",
"Description": "Fluocinolone acetonide topical oil, 0.01% (body oil) contains fluocinolone acetonide [(6α, 11β, 16α)-6, 9-difluoro-11, 21-dihydroxy-16, 17 [(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as fluocinolone acetonide topical oil, 0.01% (scalp oil) for use with shower caps for treatment of scalp psoriasis in adults, and as fluocinolone acetonide oil, 0.01% (ear drops) for treatment of chronic eczematous external otitis. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of fluocinolone acetonide topical oil, 0.01% (body oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Fluocinolone acetonide topical oil, 0.01% (body oil) is formulated with 48% refined peanut oil NF."
},
{
"NDCCode": "50090-2884-0",
"PackageDescription": "30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (50090-2884-0) ",
"NDC11Code": "50090-2884-00",
"ProductNDC": "50090-2884",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074984",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170227",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg, 180 mg, 240 mg or 300 mg diltiazem hydrochloride. Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11."
},
{
"NDCCode": "0944-0490-01",
"PackageDescription": "20 mL in 1 BOTTLE, GLASS (0944-0490-01)",
"NDC11Code": "00944-0490-01",
"ProductNDC": "0944-0490",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Buminate",
"NonProprietaryName": "Albumin Human",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19540317",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101452",
"LabelerName": "Baxalta US Inc.",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": ".25",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-11-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0944-0491-01",
"PackageDescription": "250 mL in 1 BOTTLE, GLASS (0944-0491-01)",
"NDC11Code": "00944-0491-01",
"ProductNDC": "0944-0491",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Buminate",
"NonProprietaryName": "Albumin Human",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19550616",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101452",
"LabelerName": "Baxalta US Inc.",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-11-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0944-0493-01",
"PackageDescription": "12 BAG in 1 CARTON (0944-0493-01) / 50 mL in 1 BAG (0944-0493-03) ",
"NDC11Code": "00944-0493-01",
"ProductNDC": "0944-0493",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Flexbumin",
"NonProprietaryName": "Albumin Human",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20020809",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101452",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": ".25",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020809",
"SamplePackage": "N",
"IndicationAndUsage": "FLEXBUMIN® 25% [Albumin (Human)] is indicated for hypovolemia, hypoalbuminemia, cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN).",
"Description": "FLEXBUMIN 25% is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. Each 100 mL contains 25 g of albumin. It has been adjusted to physiological pH with sodium bicarbonate and/or sodium hydroxide and stabilized with N-acetyltryptophan (0.02M) and sodium caprylate (0.02M). The sodium content is 145 ± 15 mEq/L. FLEXBUMIN 25% contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. FLEXBUMIN 25% is a transparent or slightly opalescent solution which may have a greenish tint or may vary from a pale straw to an amber color and is clear of particulate matter. FLEXBUMIN 25% is manufactured from human plasma by the modified Cohn-Oncley cold ethanol fractionation process, which includes a series of cold-ethanol precipitation, centrifugation and/or filtration steps followed by pasteurization of the final product at 60 ± 0.5°C for 10 to 11 hours. This process accomplishes both purification of albumin and reduction of viruses. In vitro studies demonstrate that the manufacturing process for FLEXBUMIN 25% provides for effective viral reduction. These viral reduction studies, summarized in Table 2, demonstrate viral clearance during the manufacturing process for FLEXBUMIN 25%. These studies indicate that specific steps in the manufacturing of FLEXBUMIN 25% are capable of eliminating/inactivating a wide range of relevant and model viruses. Since the mechanism of virus elimination/inactivation by fractionation and by heating steps is different, the overall manufacturing process of FLEXBUMIN 25% is effective in reducing viral load. The likelihood of the presence of viable hepatitis viruses has been minimized by testing the plasma at three stages: for the presence of hepatitis viruses, by fractionation steps with demonstrated virus removal capacity and by heating the product for 10 hours at 60°C. This procedure has been shown to be an effective method of inactivating hepatitis virus in albumin solutions even when those solutions were prepared from plasma known to be infective.1,2,3."
},
{
"NDCCode": "0944-2620-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-2620-01) * 1 BOTTLE in 1 CARTON > 10 mL in 1 BOTTLE * 10 mL in 1 BOTTLE (0338-0764-61)",
"NDC11Code": "00944-2620-01",
"ProductNDC": "0944-2620",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Gammagard",
"ProprietaryNameSuffix": "S/d",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "KIT",
"StartMarketingDate": "19980501",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103133",
"LabelerName": "Baxalta US Inc.",
"Status": "Deprecated",
"LastUpdate": "2018-12-05",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0944-2705-10",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0944-2705-10) / 100 mL in 1 VIAL, GLASS (0944-2705-01) ",
"NDC11Code": "00944-2705-10",
"ProductNDC": "0944-2705",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Gammagard Liquid Erc",
"NonProprietaryName": "Immune Globulin Infusion (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250714",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125105",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250714",
"SamplePackage": "N",
"IndicationAndUsage": "GAMMAGARD LIQUID ERC is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.",
"Description": "GAMMAGARD LIQUID ERC (human immunoglobulin) is a single-dose sterile, liquid preparation of purified and concentrated IgG antibodies. GAMMAGARD LIQUID ERC has an IgA concentration less than or equal to 2 µg/mL, in a 10% solution. The distribution of the IgG subclasses is similar to that of normal plasma with lower levels of IgG4 and IgG3. The Fc and Fab functions are maintained in GAMMAGARD LIQUID ERC. Pre-kallikrein activator activity is not detectable. GAMMAGARD LIQUID ERC contains 100 mg/mL protein. At least 98% of the protein is immune globulin, the average IgA concentration is less than or equal to 2 µg/mL, in a 10% solution and immunoglobulin M is present in trace amounts. GAMMAGARD LIQUID ERC contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent. There are no added sugars, sodium, or preservatives. The pH is 4.6 to 5.1. The osmolality is 240 to 300 mOsmol/kg, which is similar to physiological osmolality (285 to 295 mOsmol/kg). GAMMAGARD LIQUID ERC is manufactured from large pools of human plasma. IgG preparations are purified from plasma pools using a modified Cohn-Oncley cold ethanol fractionation process, as well as cation and anion exchange chromatography. GAMMAGARD LIQUID ERC shares its manufacturing process with GAMMAGARD LIQUID. The differentiation occurs with the modified parameters applied during the anion exchange chromatography step enhanced removal capability (ERC) to reduce IgA content, resulting in a product with IgA less than or equal to 2 µg/mL in a 10% solution. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of GAMMAGARD LIQUID ERC is collected only at FDA-approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, mini-pools of the plasma are tested for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT) and found to be negative. To improve the margin of safety, validated virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment, nanofiltration, and a low pH incubation at elevated temperature (30° to 32°C). The S/D process includes treatment with an organic mixture of tri-n-butyl phosphate, octoxynol 9 and polysorbate 80 at 18° to 25°C for a minimum of 60 minutes. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes. In vitro virus spiking studies have been used to validate the capability of the manufacturing process to inactivate and remove viruses. To establish the minimum applicable virus clearance capacity of the manufacturing process, virus clearance studies were performed under extreme conditions (e.g., at minimum S/D concentrations, incubation time and temperature for the S/D treatment). Virus clearance studies for GAMMAGARD LIQUID ERC performed in accordance with good laboratory practices are summarized in Table 6."
},
{
"NDCCode": "0944-2802-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-2802-01) * 1 VIAL, GLASS in 1 CARTON > 25 mL in 1 VIAL, GLASS * 1 VIAL, GLASS in 1 CARTON > 25 mL in 1 VIAL, GLASS",
"NDC11Code": "00944-2802-01",
"ProductNDC": "0944-2802",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aralast",
"ProprietaryNameSuffix": "Np",
"NonProprietaryName": "Alpha-1 Proteinase Inhibitor Human",
"DosageFormName": "KIT",
"StartMarketingDate": "20100419",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125039",
"LabelerName": "Baxter Healthcare Corporation",
"Status": "Deprecated",
"LastUpdate": "2015-09-04"
},
{
"NDCCode": "0944-2812-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-2812-01) * 1 VIAL, GLASS in 1 CARTON > 25 mL in 1 VIAL, GLASS * 1 VIAL, GLASS in 1 CARTON > 25 mL in 1 VIAL, GLASS",
"NDC11Code": "00944-2812-01",
"ProductNDC": "0944-2812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aralast",
"ProprietaryNameSuffix": "Np",
"NonProprietaryName": "Alpha-1 Proteinase Inhibitor Human",
"DosageFormName": "KIT",
"StartMarketingDate": "20100901",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125039",
"LabelerName": "Baxter Healthcare Corporation",
"Status": "Deprecated",
"LastUpdate": "2015-09-04"
},
{
"NDCCode": "0944-2814-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-2814-01) * 25 mL in 1 VIAL, GLASS (64764-518-25) * 25 mL in 1 VIAL (0944-2803-03) ",
"NDC11Code": "00944-2814-01",
"ProductNDC": "0944-2814",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Aralast",
"ProprietaryNameSuffix": "Np",
"NonProprietaryName": "Alpha-1-proteinase Inhibitor (human)",
"DosageFormName": "KIT",
"StartMarketingDate": "20021223",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125039",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021223",
"SamplePackage": "N",
"IndicationAndUsage": "ARALAST NP is an Alpha1-Proteinase Inhibitor (Alpha1-PI) indicated for chronic augmentation therapy in adults with clinically evident emphysema due to severe congenital deficiency of Alpha1-PI (alpha1-antitrypsin deficiency). ARALAST NP increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI. The effect of augmentation therapy with any Alpha1-PI, including ARALAST NP, on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy with ARALAST NP or ARALAST are not available. ARALAST NP is not indicated as therapy for lung disease in patients in whom severe congenital Alpha1-PI deficiency has not been established.",
"Description": "ARALAST NP contains approximately 2% Alpha1-PI with truncated C-terminal lysine (removal of Lys394), whereas ARALAST contains approximately 67% Alpha1-PI with the C-terminal lysine truncation.8 No known data suggest influence of these structural modifications on the functional activity and immunogenicity of Alpha1-PI.9. ARALAST NP is a sterile, lyophilized preparation of purified human alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT).1 ARALAST NP is a similar product to ARALAST, containing the same active components of plasma Alpha1-PI with identical formulations. ARALAST NP is prepared from large pools of human plasma by using the cold ethanol fractionation process, followed by purification steps including polyethylene glycol and zinc chloride precipitations and ion exchange chromatography. To reduce the risk of viral transmission, the manufacturing process includes treatment with a solvent detergent (S/D) mixture [tri-n-butyl phosphate and polysorbate 80] to inactivate enveloped viral agents such as human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV). In addition, a nanofiltration step is incorporated into the manufacturing process to reduce the risk of transmission of enveloped and non-enveloped viral agents. Based on in vitro studies, the process used to produce ARALAST NP has been shown to inactivate and/or partition various viruses as shown in Table 3 below. The unreconstituted, lyophilized cake should be white or off-white to slightly yellow-green or yellow in color. When reconstituted as directed, the concentration of functionally active Alpha1-PI is 16.0 – 26.0 mg/mL and the specific activity is ≥0.55 mg active Alpha1-PI/mg total protein. The composition of the reconstituted product is as follows. Each vial of ARALAST NP has the functional activity, as determined by inhibition of porcine pancreatic elastase, stated on the label. The formulation contains no preservative. The pH of the solution ranges from 7.2 to 7.8. Product must only be administered intravenously."
},
{
"NDCCode": "0944-2815-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-2815-01) * 50 mL in 1 VIAL (0944-2804-04) * 50 mL in 1 VIAL, GLASS (64764-519-50) ",
"NDC11Code": "00944-2815-01",
"ProductNDC": "0944-2815",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Aralast",
"ProprietaryNameSuffix": "Np",
"NonProprietaryName": "Alpha-1-proteinase Inhibitor (human)",
"DosageFormName": "KIT",
"StartMarketingDate": "20021223",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125039",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021223",
"SamplePackage": "N",
"IndicationAndUsage": "ARALAST NP is an Alpha1-Proteinase Inhibitor (Alpha1-PI) indicated for chronic augmentation therapy in adults with clinically evident emphysema due to severe congenital deficiency of Alpha1-PI (alpha1-antitrypsin deficiency). ARALAST NP increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI. The effect of augmentation therapy with any Alpha1-PI, including ARALAST NP, on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy with ARALAST NP or ARALAST are not available. ARALAST NP is not indicated as therapy for lung disease in patients in whom severe congenital Alpha1-PI deficiency has not been established.",
"Description": "ARALAST NP contains approximately 2% Alpha1-PI with truncated C-terminal lysine (removal of Lys394), whereas ARALAST contains approximately 67% Alpha1-PI with the C-terminal lysine truncation.8 No known data suggest influence of these structural modifications on the functional activity and immunogenicity of Alpha1-PI.9. ARALAST NP is a sterile, lyophilized preparation of purified human alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT).1 ARALAST NP is a similar product to ARALAST, containing the same active components of plasma Alpha1-PI with identical formulations. ARALAST NP is prepared from large pools of human plasma by using the cold ethanol fractionation process, followed by purification steps including polyethylene glycol and zinc chloride precipitations and ion exchange chromatography. To reduce the risk of viral transmission, the manufacturing process includes treatment with a solvent detergent (S/D) mixture [tri-n-butyl phosphate and polysorbate 80] to inactivate enveloped viral agents such as human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV). In addition, a nanofiltration step is incorporated into the manufacturing process to reduce the risk of transmission of enveloped and non-enveloped viral agents. Based on in vitro studies, the process used to produce ARALAST NP has been shown to inactivate and/or partition various viruses as shown in Table 3 below. The unreconstituted, lyophilized cake should be white or off-white to slightly yellow-green or yellow in color. When reconstituted as directed, the concentration of functionally active Alpha1-PI is 16.0 – 26.0 mg/mL and the specific activity is ≥0.55 mg active Alpha1-PI/mg total protein. The composition of the reconstituted product is as follows. Each vial of ARALAST NP has the functional activity, as determined by inhibition of porcine pancreatic elastase, stated on the label. The formulation contains no preservative. The pH of the solution ranges from 7.2 to 7.8. Product must only be administered intravenously."
},
{
"NDCCode": "0944-2841-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2841-10) * 10 mL in 1 VIAL, GLASS (0944-2831-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) ",
"NDC11Code": "00944-2841-10",
"ProductNDC": "0944-2841",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Recombinate",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20090410",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103375",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090410",
"SamplePackage": "N",
"IndicationAndUsage": "The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.",
"Description": "RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate."
},
{
"NDCCode": "0944-2842-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2842-10) * 10 mL in 1 VIAL, GLASS (0944-2832-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) ",
"NDC11Code": "00944-2842-10",
"ProductNDC": "0944-2842",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Recombinate",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20090410",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103375",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090410",
"SamplePackage": "N",
"IndicationAndUsage": "The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.",
"Description": "RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate."
},
{
"NDCCode": "0944-2843-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2843-10) * 10 mL in 1 VIAL, GLASS (0944-2833-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) ",
"NDC11Code": "00944-2843-10",
"ProductNDC": "0944-2843",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Recombinate",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20090410",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103375",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
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"IndicationAndUsage": "The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.",
"Description": "RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate."
},
{
"NDCCode": "0944-2844-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2844-10) * 10 mL in 1 VIAL, GLASS (0944-2834-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) ",
"NDC11Code": "00944-2844-10",
"ProductNDC": "0944-2844",
"ProductTypeName": "PLASMA DERIVATIVE",
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"DosageFormName": "KIT",
"StartMarketingDate": "20100315",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103375",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
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"LastUpdate": "2025-04-25",
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"IndicationAndUsage": "The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.",
"Description": "RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate."
},
{
"NDCCode": "0944-2845-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2845-10) * 10 mL in 1 VIAL, GLASS (0944-2835-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) ",
"NDC11Code": "00944-2845-10",
"ProductNDC": "0944-2845",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Recombinate",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20100315",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103375",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20100315",
"SamplePackage": "N",
"IndicationAndUsage": "The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.",
"Description": "RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate."
},
{
"NDCCode": "0944-2850-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-01) / 5 mL in 1 VIAL, SINGLE-USE (0944-2850-02) ",
"NDC11Code": "00944-2850-01",
"ProductNDC": "0944-2850",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Cuvitru",
"NonProprietaryName": "Immune Globulin Subcutaneous (human)",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20161018",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125596",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20161018",
"SamplePackage": "N",
"IndicationAndUsage": "CUVITRU is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Solution indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies1,2.",
"Description": "CUVITRU is a ready-for-use, sterile, liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in CUVITRU. CUVITRU has a purity ≥98% IgG and a pH of 4.6 to 5.1. The osmolality is 280-292 milli-osmoles per kilogram. CUVITRU contains 200 milligram/mL protein. The average immunoglobulin A (IgA) concentration is 80 mcg/mL. CUVITRU contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent, and there are no added sugars, sodium or preservatives. CUVITRU is manufactured from large pools of human plasma. IgG preparations are purified from plasma pools using a modified Cohn-Oncley cold ethanol fractionation process, as well as cation and anion exchange chromatography. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of CUVITRU is collected only at FDA approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, mini-pools of the plasma are tested for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT) and found to be negative. To further improve the margin of safety, validated virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment13, 35 nm nanofiltration, and a low pH incubation at elevated temperature (30°C to 32°C). The S/D process includes treatment with an organic mixture of tri-n-butyl phosphate, octoxynol 9 and polysorbate 80 at 18°C to 25°C for a minimum of 60 minutes. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes13. The ethanol fractionation process provides an additional virus clearance capacity. In vitro virus spiking studies have been used to validate the capability of the manufacturing process to inactivate and remove viruses. To establish the minimum applicable virus clearance capacity of the manufacturing process, these virus clearance studies were performed under extreme conditions (e.g., at minimum S/D concentrations, incubation time and temperature for the S/D treatment). Virus clearance studies for CUVITRU performed in accordance with good laboratory practices are summarized in Table 7."
},
{
"NDCCode": "0944-2921-02",
"PackageDescription": "1 KIT in 1 CARTON (0944-2921-02) * 5 mL in 1 VIAL, GLASS (0944-2941-01) * 2 mL in 1 VIAL, GLASS (52919-008-05) ",
"NDC11Code": "00944-2921-02",
"ProductNDC": "0944-2921",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Advate",
"NonProprietaryName": "Antihemophilic Factor, Human Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20030725",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125063",
"LabelerName": "Baxalta US Inc.",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20030725",
"SamplePackage": "N"
},
{
"NDCCode": "0944-2922-02",
"PackageDescription": "1 KIT in 1 CARTON (0944-2922-02) * 5 mL in 1 VIAL, GLASS (0944-2942-01) * 2 mL in 1 VIAL, GLASS (52919-008-05) ",
"NDC11Code": "00944-2922-02",
"ProductNDC": "0944-2922",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Advate",
"NonProprietaryName": "Antihemophilic Factor, Human Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20120712",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125063",
"LabelerName": "Baxalta US Inc.",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20120712",
"SamplePackage": "N"
},
{
"NDCCode": "0944-2923-02",
"PackageDescription": "1 KIT in 1 CARTON (0944-2923-02) * 5 mL in 1 VIAL, GLASS (0944-2943-01) * 2 mL in 1 VIAL, GLASS (52919-008-05) ",
"NDC11Code": "00944-2923-02",
"ProductNDC": "0944-2923",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Advate",
"NonProprietaryName": "Antihemophilic Factor, Human Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20120712",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125063",
"LabelerName": "Baxalta US Inc.",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20120712",
"SamplePackage": "N"
},
{
"NDCCode": "0944-2924-02",
"PackageDescription": "1 KIT in 1 CARTON (0944-2924-02) * 5 mL in 1 VIAL, GLASS (0944-2944-01) * 2 mL in 1 VIAL, GLASS (52919-008-05) ",
"NDC11Code": "00944-2924-02",
"ProductNDC": "0944-2924",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Advate",
"NonProprietaryName": "Antihemophilic Factor, Human Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20120712",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125063",
"LabelerName": "Baxalta US Inc.",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20120712",
"SamplePackage": "N"
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<NDCList>
<NDC>
<NDCCode>0944-2884-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (0944-2884-01) / 50 mL in 1 VIAL, GLASS (0944-2884-02) </PackageDescription>
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<SubstanceName>.ALPHA.1-PROTEINASE INHIBITOR HUMAN</SubstanceName>
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<Status>Active</Status>
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<IndicationAndUsage>GLASSIA is an Alpha1-Proteinase Inhibitor (Human), indicated for chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe hereditary deficiency of Alpha1-PI, also known as alpha1-antitrypsin (AAT) deficiency. Limitations of Use: 1 The effect of augmentation therapy with GLASSIA or any Alpha1-PI product on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials., 2 Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available., 3 GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.</IndicationAndUsage>
<Description>GLASSIA is a sterile, ready to use, liquid preparation of purified human Alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT). The solution contains 2% active Alpha1-PI in a phosphate-buffered saline solution. The specific activity of GLASSIA is ≥ 0.7 mg functional Alpha1-PI per mg of total protein. Not less than 90% of the Alpha1-PI in GLASSIA is of the monomeric form as measured by size-exclusion chromatography. GLASSIA is prepared from human plasma obtained from US-licensed plasma collection centers by a modified version of the cold ethanol fractionation process and the Alpha1-PI is then purified using chromatographic methods. Individual plasma units used for production of GLASSIA are tested using FDA- licensed serological assays for hepatitis B surface antigen (HBsAg) and for antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 (HIV-1/2), as well as by FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1. Each plasma unit must be non-reactive (negative) in all tests. Plasma is also tested by in-process NAT procedures for parvovirus B19 and the limit for B19 DNA in the manufacturing pool is set not to exceed 104 IU per mL. To reduce the risk of viral transmission, the manufacturing process for GLASSIA includes two steps specifically designed to remove or inactivate viruses. The first of these is nanofiltration (NF) through a 15 nm filter which can remove both enveloped and non–enveloped viral agents and the second is solvent/detergent (S/D) treatment with a mixture of tri-(n-butyl) phosphate (TNBP) and Polysorbate 80 (Tween 80) which inactivates enveloped viral agents such as HIV, HBV and HCV. The effectiveness of the S/D treatment and nanofiltration procedures for reducing virus content has been assessed using a series of viruses with a range of physico-chemical characteristics. The results of the viral challenge studies are summarized in Table 4.</Description>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GLASSIA is an Alpha1-Proteinase Inhibitor (Human), indicated for chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe hereditary deficiency of Alpha1-PI, also known as alpha1-antitrypsin (AAT) deficiency. Limitations of Use: 1 The effect of augmentation therapy with GLASSIA or any Alpha1-PI product on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials., 2 Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available., 3 GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.</IndicationAndUsage>
<Description>GLASSIA is a sterile, ready to use, liquid preparation of purified human Alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT). The solution contains 2% active Alpha1-PI in a phosphate-buffered saline solution. The specific activity of GLASSIA is ≥ 0.7 mg functional Alpha1-PI per mg of total protein. Not less than 90% of the Alpha1-PI in GLASSIA is of the monomeric form as measured by size-exclusion chromatography. GLASSIA is prepared from human plasma obtained from US-licensed plasma collection centers by a modified version of the cold ethanol fractionation process and the Alpha1-PI is then purified using chromatographic methods. Individual plasma units used for production of GLASSIA are tested using FDA- licensed serological assays for hepatitis B surface antigen (HBsAg) and for antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 (HIV-1/2), as well as by FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1. Each plasma unit must be non-reactive (negative) in all tests. Plasma is also tested by in-process NAT procedures for parvovirus B19 and the limit for B19 DNA in the manufacturing pool is set not to exceed 104 IU per mL. To reduce the risk of viral transmission, the manufacturing process for GLASSIA includes two steps specifically designed to remove or inactivate viruses. The first of these is nanofiltration (NF) through a 15 nm filter which can remove both enveloped and non–enveloped viral agents and the second is solvent/detergent (S/D) treatment with a mixture of tri-(n-butyl) phosphate (TNBP) and Polysorbate 80 (Tween 80) which inactivates enveloped viral agents such as HIV, HBV and HCV. The effectiveness of the S/D treatment and nanofiltration procedures for reducing virus content has been assessed using a series of viruses with a range of physico-chemical characteristics. The results of the viral challenge studies are summarized in Table 4.</Description>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GLASSIA is an Alpha1-Proteinase Inhibitor (Human), indicated for chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe hereditary deficiency of Alpha1-PI, also known as alpha1-antitrypsin (AAT) deficiency. Limitations of Use: 1 The effect of augmentation therapy with GLASSIA or any Alpha1-PI product on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials., 2 Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available., 3 GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.</IndicationAndUsage>
<Description>GLASSIA is a sterile, ready to use, liquid preparation of purified human Alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT). The solution contains 2% active Alpha1-PI in a phosphate-buffered saline solution. The specific activity of GLASSIA is ≥ 0.7 mg functional Alpha1-PI per mg of total protein. Not less than 90% of the Alpha1-PI in GLASSIA is of the monomeric form as measured by size-exclusion chromatography. GLASSIA is prepared from human plasma obtained from US-licensed plasma collection centers by a modified version of the cold ethanol fractionation process and the Alpha1-PI is then purified using chromatographic methods. Individual plasma units used for production of GLASSIA are tested using FDA- licensed serological assays for hepatitis B surface antigen (HBsAg) and for antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 (HIV-1/2), as well as by FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1. Each plasma unit must be non-reactive (negative) in all tests. Plasma is also tested by in-process NAT procedures for parvovirus B19 and the limit for B19 DNA in the manufacturing pool is set not to exceed 104 IU per mL. To reduce the risk of viral transmission, the manufacturing process for GLASSIA includes two steps specifically designed to remove or inactivate viruses. The first of these is nanofiltration (NF) through a 15 nm filter which can remove both enveloped and non–enveloped viral agents and the second is solvent/detergent (S/D) treatment with a mixture of tri-(n-butyl) phosphate (TNBP) and Polysorbate 80 (Tween 80) which inactivates enveloped viral agents such as HIV, HBV and HCV. The effectiveness of the S/D treatment and nanofiltration procedures for reducing virus content has been assessed using a series of viruses with a range of physico-chemical characteristics. The results of the viral challenge studies are summarized in Table 4.</Description>
</NDC>
<NDC>
<NDCCode>0591-2884-01</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0591-2884-01) </PackageDescription>
<NDC11Code>00591-2884-01</NDC11Code>
<ProductNDC>0591-2884</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900529</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019614</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals Inc</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19900529</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil hydrochloride sustained-release capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
<Description>Verapamil hydrochloride sustained-release capsules are calcium ion influx inhibitors (slow channel blockers or calcium ion antagonists). Verapamil hydrochloride sustained-release capsules are available for oral administration as a 360 mg hard gelatin capsule (lavender cap/yellow body), a 240 mg hard gelatin capsule (dark blue cap/yellow body), a 180 mg hard gelatin capsule (light grey cap/yellow body), and a 120 mg hard gelatin capsule (yellow cap/yellow body). These pellet-filled capsules provide a sustained-release of the drug in the gastrointestinal tract. The structural formula of verapamil HCl is given below. C27H38N2O4HCl M.W. 491.07. Chemical name: Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) monohydrochloride. Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not structurally related to other cardioactive drugs. In addition to verapamil HCl the verapamil hydrochloride sustained-release capsules contain the following inactive ingredients: fumaric acid, talc, sugar spheres, povidone, shellac, gelatin, FD&C red #40, yellow iron oxide, titanium dioxide, methylparaben, propylparaben, silicon dioxide, and sodium lauryl sulfate. In addition, the verapamil hydrochloride sustained-release capsules 240 mg and 360 mg capsules contain FD&C blue #1 and D&C red #28; and the verapamil hydrochloride sustained-release capsules 180 mg contain black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>36987-2884-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-2884-1)</PackageDescription>
<NDC11Code>36987-2884-01</NDC11Code>
<ProductNDC>36987-2884</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Virginia Live Oak</ProprietaryName>
<NonProprietaryName>Virginia Live Oak</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>QUERCUS VIRGINIANA POLLEN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-2884-1</NDCCode>
<PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-2884-1) </PackageDescription>
<NDC11Code>37662-2884-01</NDC11Code>
<ProductNDC>37662-2884</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kali Aceticum</ProprietaryName>
<NonProprietaryName>Kali Aceticum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230328</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>POTASSIUM ACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/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>2023-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-2884-1</NDCCode>
<PackageDescription>90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (50090-2884-1) </PackageDescription>
<NDC11Code>50090-2884-01</NDC11Code>
<ProductNDC>50090-2884</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074984</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg, 180 mg, 240 mg or 300 mg diltiazem hydrochloride. Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11.</Description>
</NDC>
<NDC>
<NDCCode>62991-2884-1</NDCCode>
<PackageDescription>1 g in 1 JAR (62991-2884-1)</PackageDescription>
<NDC11Code>62991-2884-01</NDC11Code>
<ProductNDC>62991-2884</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20101109</StartMarketingDate>
<EndMarketingDate>20140630</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>LETCO MEDICAL, LLC</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20140630</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63629-2884-1</NDCCode>
<PackageDescription>1 TABLET in 1 BOTTLE (63629-2884-1) </PackageDescription>
<NDC11Code>63629-2884-01</NDC11Code>
<ProductNDC>63629-2884</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diovan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021283</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-2884-1</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71335-2884-1) / 118.28 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>71335-2884-01</NDC11Code>
<ProductNDC>71335-2884</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212760</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.11</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone acetonide topical oil, 0.01% is a corticosteroid indicated for the : 1 topical treatment of atopic dermatitis in adult patients (1.1), 2 topical treatment of moderato to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks (1.2).</IndicationAndUsage>
<Description>Fluocinolone acetonide topical oil, 0.01% (body oil) contains fluocinolone acetonide [(6α, 11β, 16α)-6, 9-difluoro-11, 21-dihydroxy-16, 17 [(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as fluocinolone acetonide topical oil, 0.01% (scalp oil) for use with shower caps for treatment of scalp psoriasis in adults, and as fluocinolone acetonide oil, 0.01% (ear drops) for treatment of chronic eczematous external otitis. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of fluocinolone acetonide topical oil, 0.01% (body oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Fluocinolone acetonide topical oil, 0.01% (body oil) is formulated with 48% refined peanut oil NF.</Description>
</NDC>
<NDC>
<NDCCode>50090-2884-0</NDCCode>
<PackageDescription>30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (50090-2884-0) </PackageDescription>
<NDC11Code>50090-2884-00</NDC11Code>
<ProductNDC>50090-2884</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074984</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg, 180 mg, 240 mg or 300 mg diltiazem hydrochloride. Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11.</Description>
</NDC>
<NDC>
<NDCCode>0944-0490-01</NDCCode>
<PackageDescription>20 mL in 1 BOTTLE, GLASS (0944-0490-01)</PackageDescription>
<NDC11Code>00944-0490-01</NDC11Code>
<ProductNDC>0944-0490</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Buminate</ProprietaryName>
<NonProprietaryName>Albumin Human</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19540317</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101452</ApplicationNumber>
<LabelerName>Baxalta US Inc.</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0944-0491-01</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, GLASS (0944-0491-01)</PackageDescription>
<NDC11Code>00944-0491-01</NDC11Code>
<ProductNDC>0944-0491</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Buminate</ProprietaryName>
<NonProprietaryName>Albumin Human</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19550616</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101452</ApplicationNumber>
<LabelerName>Baxalta US Inc.</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0944-0493-01</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (0944-0493-01) / 50 mL in 1 BAG (0944-0493-03) </PackageDescription>
<NDC11Code>00944-0493-01</NDC11Code>
<ProductNDC>0944-0493</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Flexbumin</ProprietaryName>
<NonProprietaryName>Albumin Human</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20020809</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101452</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>g/mL</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>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FLEXBUMIN® 25% [Albumin (Human)] is indicated for hypovolemia, hypoalbuminemia, cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN).</IndicationAndUsage>
<Description>FLEXBUMIN 25% is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. Each 100 mL contains 25 g of albumin. It has been adjusted to physiological pH with sodium bicarbonate and/or sodium hydroxide and stabilized with N-acetyltryptophan (0.02M) and sodium caprylate (0.02M). The sodium content is 145 ± 15 mEq/L. FLEXBUMIN 25% contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. FLEXBUMIN 25% is a transparent or slightly opalescent solution which may have a greenish tint or may vary from a pale straw to an amber color and is clear of particulate matter. FLEXBUMIN 25% is manufactured from human plasma by the modified Cohn-Oncley cold ethanol fractionation process, which includes a series of cold-ethanol precipitation, centrifugation and/or filtration steps followed by pasteurization of the final product at 60 ± 0.5°C for 10 to 11 hours. This process accomplishes both purification of albumin and reduction of viruses. In vitro studies demonstrate that the manufacturing process for FLEXBUMIN 25% provides for effective viral reduction. These viral reduction studies, summarized in Table 2, demonstrate viral clearance during the manufacturing process for FLEXBUMIN 25%. These studies indicate that specific steps in the manufacturing of FLEXBUMIN 25% are capable of eliminating/inactivating a wide range of relevant and model viruses. Since the mechanism of virus elimination/inactivation by fractionation and by heating steps is different, the overall manufacturing process of FLEXBUMIN 25% is effective in reducing viral load. The likelihood of the presence of viable hepatitis viruses has been minimized by testing the plasma at three stages: for the presence of hepatitis viruses, by fractionation steps with demonstrated virus removal capacity and by heating the product for 10 hours at 60°C. This procedure has been shown to be an effective method of inactivating hepatitis virus in albumin solutions even when those solutions were prepared from plasma known to be infective.1,2,3.</Description>
</NDC>
<NDC>
<NDCCode>0944-2620-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2620-01) * 1 BOTTLE in 1 CARTON > 10 mL in 1 BOTTLE * 10 mL in 1 BOTTLE (0338-0764-61)</PackageDescription>
<NDC11Code>00944-2620-01</NDC11Code>
<ProductNDC>0944-2620</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Gammagard</ProprietaryName>
<ProprietaryNameSuffix>S/d</ProprietaryNameSuffix>
<NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19980501</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103133</ApplicationNumber>
<LabelerName>Baxalta US Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-12-05</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0944-2705-10</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (0944-2705-10) / 100 mL in 1 VIAL, GLASS (0944-2705-01) </PackageDescription>
<NDC11Code>00944-2705-10</NDC11Code>
<ProductNDC>0944-2705</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Gammagard Liquid Erc</ProprietaryName>
<NonProprietaryName>Immune Globulin Infusion (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250714</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125105</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GAMMAGARD LIQUID ERC is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.</IndicationAndUsage>
<Description>GAMMAGARD LIQUID ERC (human immunoglobulin) is a single-dose sterile, liquid preparation of purified and concentrated IgG antibodies. GAMMAGARD LIQUID ERC has an IgA concentration less than or equal to 2 µg/mL, in a 10% solution. The distribution of the IgG subclasses is similar to that of normal plasma with lower levels of IgG4 and IgG3. The Fc and Fab functions are maintained in GAMMAGARD LIQUID ERC. Pre-kallikrein activator activity is not detectable. GAMMAGARD LIQUID ERC contains 100 mg/mL protein. At least 98% of the protein is immune globulin, the average IgA concentration is less than or equal to 2 µg/mL, in a 10% solution and immunoglobulin M is present in trace amounts. GAMMAGARD LIQUID ERC contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent. There are no added sugars, sodium, or preservatives. The pH is 4.6 to 5.1. The osmolality is 240 to 300 mOsmol/kg, which is similar to physiological osmolality (285 to 295 mOsmol/kg). GAMMAGARD LIQUID ERC is manufactured from large pools of human plasma. IgG preparations are purified from plasma pools using a modified Cohn-Oncley cold ethanol fractionation process, as well as cation and anion exchange chromatography. GAMMAGARD LIQUID ERC shares its manufacturing process with GAMMAGARD LIQUID. The differentiation occurs with the modified parameters applied during the anion exchange chromatography step enhanced removal capability (ERC) to reduce IgA content, resulting in a product with IgA less than or equal to 2 µg/mL in a 10% solution. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of GAMMAGARD LIQUID ERC is collected only at FDA-approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, mini-pools of the plasma are tested for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT) and found to be negative. To improve the margin of safety, validated virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment, nanofiltration, and a low pH incubation at elevated temperature (30° to 32°C). The S/D process includes treatment with an organic mixture of tri-n-butyl phosphate, octoxynol 9 and polysorbate 80 at 18° to 25°C for a minimum of 60 minutes. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes. In vitro virus spiking studies have been used to validate the capability of the manufacturing process to inactivate and remove viruses. To establish the minimum applicable virus clearance capacity of the manufacturing process, virus clearance studies were performed under extreme conditions (e.g., at minimum S/D concentrations, incubation time and temperature for the S/D treatment). Virus clearance studies for GAMMAGARD LIQUID ERC performed in accordance with good laboratory practices are summarized in Table 6.</Description>
</NDC>
<NDC>
<NDCCode>0944-2802-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2802-01) * 1 VIAL, GLASS in 1 CARTON > 25 mL in 1 VIAL, GLASS * 1 VIAL, GLASS in 1 CARTON > 25 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00944-2802-01</NDC11Code>
<ProductNDC>0944-2802</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aralast</ProprietaryName>
<ProprietaryNameSuffix>Np</ProprietaryNameSuffix>
<NonProprietaryName>Alpha-1 Proteinase Inhibitor Human</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100419</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125039</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2015-09-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>0944-2812-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2812-01) * 1 VIAL, GLASS in 1 CARTON > 25 mL in 1 VIAL, GLASS * 1 VIAL, GLASS in 1 CARTON > 25 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00944-2812-01</NDC11Code>
<ProductNDC>0944-2812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aralast</ProprietaryName>
<ProprietaryNameSuffix>Np</ProprietaryNameSuffix>
<NonProprietaryName>Alpha-1 Proteinase Inhibitor Human</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100901</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125039</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2015-09-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>0944-2814-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2814-01) * 25 mL in 1 VIAL, GLASS (64764-518-25) * 25 mL in 1 VIAL (0944-2803-03) </PackageDescription>
<NDC11Code>00944-2814-01</NDC11Code>
<ProductNDC>0944-2814</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Aralast</ProprietaryName>
<ProprietaryNameSuffix>Np</ProprietaryNameSuffix>
<NonProprietaryName>Alpha-1-proteinase Inhibitor (human)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20021223</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125039</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARALAST NP is an Alpha1-Proteinase Inhibitor (Alpha1-PI) indicated for chronic augmentation therapy in adults with clinically evident emphysema due to severe congenital deficiency of Alpha1-PI (alpha1-antitrypsin deficiency). ARALAST NP increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI. The effect of augmentation therapy with any Alpha1-PI, including ARALAST NP, on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy with ARALAST NP or ARALAST are not available. ARALAST NP is not indicated as therapy for lung disease in patients in whom severe congenital Alpha1-PI deficiency has not been established.</IndicationAndUsage>
<Description>ARALAST NP contains approximately 2% Alpha1-PI with truncated C-terminal lysine (removal of Lys394), whereas ARALAST contains approximately 67% Alpha1-PI with the C-terminal lysine truncation.8 No known data suggest influence of these structural modifications on the functional activity and immunogenicity of Alpha1-PI.9. ARALAST NP is a sterile, lyophilized preparation of purified human alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT).1 ARALAST NP is a similar product to ARALAST, containing the same active components of plasma Alpha1-PI with identical formulations. ARALAST NP is prepared from large pools of human plasma by using the cold ethanol fractionation process, followed by purification steps including polyethylene glycol and zinc chloride precipitations and ion exchange chromatography. To reduce the risk of viral transmission, the manufacturing process includes treatment with a solvent detergent (S/D) mixture [tri-n-butyl phosphate and polysorbate 80] to inactivate enveloped viral agents such as human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV). In addition, a nanofiltration step is incorporated into the manufacturing process to reduce the risk of transmission of enveloped and non-enveloped viral agents. Based on in vitro studies, the process used to produce ARALAST NP has been shown to inactivate and/or partition various viruses as shown in Table 3 below. The unreconstituted, lyophilized cake should be white or off-white to slightly yellow-green or yellow in color. When reconstituted as directed, the concentration of functionally active Alpha1-PI is 16.0 – 26.0 mg/mL and the specific activity is ≥0.55 mg active Alpha1-PI/mg total protein. The composition of the reconstituted product is as follows. Each vial of ARALAST NP has the functional activity, as determined by inhibition of porcine pancreatic elastase, stated on the label. The formulation contains no preservative. The pH of the solution ranges from 7.2 to 7.8. Product must only be administered intravenously.</Description>
</NDC>
<NDC>
<NDCCode>0944-2815-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2815-01) * 50 mL in 1 VIAL (0944-2804-04) * 50 mL in 1 VIAL, GLASS (64764-519-50) </PackageDescription>
<NDC11Code>00944-2815-01</NDC11Code>
<ProductNDC>0944-2815</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Aralast</ProprietaryName>
<ProprietaryNameSuffix>Np</ProprietaryNameSuffix>
<NonProprietaryName>Alpha-1-proteinase Inhibitor (human)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20021223</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125039</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARALAST NP is an Alpha1-Proteinase Inhibitor (Alpha1-PI) indicated for chronic augmentation therapy in adults with clinically evident emphysema due to severe congenital deficiency of Alpha1-PI (alpha1-antitrypsin deficiency). ARALAST NP increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI. The effect of augmentation therapy with any Alpha1-PI, including ARALAST NP, on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy with ARALAST NP or ARALAST are not available. ARALAST NP is not indicated as therapy for lung disease in patients in whom severe congenital Alpha1-PI deficiency has not been established.</IndicationAndUsage>
<Description>ARALAST NP contains approximately 2% Alpha1-PI with truncated C-terminal lysine (removal of Lys394), whereas ARALAST contains approximately 67% Alpha1-PI with the C-terminal lysine truncation.8 No known data suggest influence of these structural modifications on the functional activity and immunogenicity of Alpha1-PI.9. ARALAST NP is a sterile, lyophilized preparation of purified human alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT).1 ARALAST NP is a similar product to ARALAST, containing the same active components of plasma Alpha1-PI with identical formulations. ARALAST NP is prepared from large pools of human plasma by using the cold ethanol fractionation process, followed by purification steps including polyethylene glycol and zinc chloride precipitations and ion exchange chromatography. To reduce the risk of viral transmission, the manufacturing process includes treatment with a solvent detergent (S/D) mixture [tri-n-butyl phosphate and polysorbate 80] to inactivate enveloped viral agents such as human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV). In addition, a nanofiltration step is incorporated into the manufacturing process to reduce the risk of transmission of enveloped and non-enveloped viral agents. Based on in vitro studies, the process used to produce ARALAST NP has been shown to inactivate and/or partition various viruses as shown in Table 3 below. The unreconstituted, lyophilized cake should be white or off-white to slightly yellow-green or yellow in color. When reconstituted as directed, the concentration of functionally active Alpha1-PI is 16.0 – 26.0 mg/mL and the specific activity is ≥0.55 mg active Alpha1-PI/mg total protein. The composition of the reconstituted product is as follows. Each vial of ARALAST NP has the functional activity, as determined by inhibition of porcine pancreatic elastase, stated on the label. The formulation contains no preservative. The pH of the solution ranges from 7.2 to 7.8. Product must only be administered intravenously.</Description>
</NDC>
<NDC>
<NDCCode>0944-2841-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2841-10) * 10 mL in 1 VIAL, GLASS (0944-2831-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
<NDC11Code>00944-2841-10</NDC11Code>
<ProductNDC>0944-2841</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Recombinate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20090410</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.</Description>
</NDC>
<NDC>
<NDCCode>0944-2842-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2842-10) * 10 mL in 1 VIAL, GLASS (0944-2832-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
<NDC11Code>00944-2842-10</NDC11Code>
<ProductNDC>0944-2842</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Recombinate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20090410</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.</Description>
</NDC>
<NDC>
<NDCCode>0944-2843-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2843-10) * 10 mL in 1 VIAL, GLASS (0944-2833-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
<NDC11Code>00944-2843-10</NDC11Code>
<ProductNDC>0944-2843</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Recombinate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20090410</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.</Description>
</NDC>
<NDC>
<NDCCode>0944-2844-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2844-10) * 10 mL in 1 VIAL, GLASS (0944-2834-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
<NDC11Code>00944-2844-10</NDC11Code>
<ProductNDC>0944-2844</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Recombinate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100315</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.</Description>
</NDC>
<NDC>
<NDCCode>0944-2845-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2845-10) * 10 mL in 1 VIAL, GLASS (0944-2835-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
<NDC11Code>00944-2845-10</NDC11Code>
<ProductNDC>0944-2845</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Recombinate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100315</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.</Description>
</NDC>
<NDC>
<NDCCode>0944-2850-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-01) / 5 mL in 1 VIAL, SINGLE-USE (0944-2850-02) </PackageDescription>
<NDC11Code>00944-2850-01</NDC11Code>
<ProductNDC>0944-2850</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Cuvitru</ProprietaryName>
<NonProprietaryName>Immune Globulin Subcutaneous (human)</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20161018</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125596</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CUVITRU is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Solution indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies1,2.</IndicationAndUsage>
<Description>CUVITRU is a ready-for-use, sterile, liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in CUVITRU. CUVITRU has a purity ≥98% IgG and a pH of 4.6 to 5.1. The osmolality is 280-292 milli-osmoles per kilogram. CUVITRU contains 200 milligram/mL protein. The average immunoglobulin A (IgA) concentration is 80 mcg/mL. CUVITRU contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent, and there are no added sugars, sodium or preservatives. CUVITRU is manufactured from large pools of human plasma. IgG preparations are purified from plasma pools using a modified Cohn-Oncley cold ethanol fractionation process, as well as cation and anion exchange chromatography. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of CUVITRU is collected only at FDA approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, mini-pools of the plasma are tested for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT) and found to be negative. To further improve the margin of safety, validated virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment13, 35 nm nanofiltration, and a low pH incubation at elevated temperature (30°C to 32°C). The S/D process includes treatment with an organic mixture of tri-n-butyl phosphate, octoxynol 9 and polysorbate 80 at 18°C to 25°C for a minimum of 60 minutes. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes13. The ethanol fractionation process provides an additional virus clearance capacity. In vitro virus spiking studies have been used to validate the capability of the manufacturing process to inactivate and remove viruses. To establish the minimum applicable virus clearance capacity of the manufacturing process, these virus clearance studies were performed under extreme conditions (e.g., at minimum S/D concentrations, incubation time and temperature for the S/D treatment). Virus clearance studies for CUVITRU performed in accordance with good laboratory practices are summarized in Table 7.</Description>
</NDC>
<NDC>
<NDCCode>0944-2921-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2921-02) * 5 mL in 1 VIAL, GLASS (0944-2941-01) * 2 mL in 1 VIAL, GLASS (52919-008-05) </PackageDescription>
<NDC11Code>00944-2921-02</NDC11Code>
<ProductNDC>0944-2921</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Advate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor, Human Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20030725</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125063</ApplicationNumber>
<LabelerName>Baxalta US Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0944-2922-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2922-02) * 5 mL in 1 VIAL, GLASS (0944-2942-01) * 2 mL in 1 VIAL, GLASS (52919-008-05) </PackageDescription>
<NDC11Code>00944-2922-02</NDC11Code>
<ProductNDC>0944-2922</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Advate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor, Human Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120712</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125063</ApplicationNumber>
<LabelerName>Baxalta US Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0944-2923-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2923-02) * 5 mL in 1 VIAL, GLASS (0944-2943-01) * 2 mL in 1 VIAL, GLASS (52919-008-05) </PackageDescription>
<NDC11Code>00944-2923-02</NDC11Code>
<ProductNDC>0944-2923</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Advate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor, Human Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120712</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125063</ApplicationNumber>
<LabelerName>Baxalta US Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0944-2924-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2924-02) * 5 mL in 1 VIAL, GLASS (0944-2944-01) * 2 mL in 1 VIAL, GLASS (52919-008-05) </PackageDescription>
<NDC11Code>00944-2924-02</NDC11Code>
<ProductNDC>0944-2924</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Advate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor, Human Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120712</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125063</ApplicationNumber>
<LabelerName>Baxalta US Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>