{
"NDC": [
{
"NDCCode": "50242-175-07",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (50242-175-07) / 80 mL in 1 BOTTLE, GLASS",
"NDC11Code": "50242-0175-07",
"ProductNDC": "50242-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Evrysdi",
"NonProprietaryName": "Risdiplam",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20200807",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213535",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "RISDIPLAM",
"StrengthNumber": ".75",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Protein Synthesis [PE], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA], Survival of Motor Neuron 2 Splicing Modifier [EPC], Survival of Motor Neuron 2 Splicing Modifiers [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200807",
"SamplePackage": "N",
"IndicationAndUsage": "EVRYSDI is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.",
"Description": "EVRYSDI for oral solution and EVRYSDI tablets for oral use contain risdiplam, which is a survival of motor neuron 2 (SMN2)-directed RNA splicing modifier. The chemical name of risdiplam is 7-(4,7-diazaspiro[2.5]octan-7-yl)-2-(2,8 dimethylimidazo[1,2-b]pyridazin-6-yl)pyrido-4H-[1,2-a]pyrimidin-4-one. Risdiplam has a molecular weight of 401.46 g/mol. Risdiplam demonstrates pH-dependent aqueous solubility; the greatest solubility is at low pH, and solubility decreases with increasing pH. Risdiplam has a pKa1 of 3.78 (base) and pKa2 of 6.62 (base). The molecular formula of risdiplam is C22H23N7O and the chemical structure is shown below. EVRYSDI for oral solution is supplied as a powder in an amber glass bottle. Each bottle contains 60 mg of risdiplam. The inactive ingredients of EVRYSDI are: ascorbic acid, disodium edetate dihydrate, isomalt, mannitol, polyethylene glycol 6000, sodium benzoate, strawberry flavor, sucralose, and tartaric acid. The powder is constituted with purified water to yield 60 mg/80 mL (0.75 mg/mL) of risdiplam after constitution [see Dosage and Administration (2.4)]. Each EVRYSDI tablet contains 5 mg of risdiplam. The inactive ingredients of EVRYSDI tablet are colloidal silicon dioxide, crospovidone, mannitol, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol, sodium stearyl fumarate, strawberry flavor, talc, tartaric acid, titanium dioxide, and yellow iron oxide."
},
{
"NDCCode": "11084-175-07",
"PackageDescription": "2000 mL in 1 BOTTLE, PLASTIC (11084-175-07)",
"NDC11Code": "11084-0175-07",
"ProductNDC": "11084-175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sbs Ultragreen",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130725",
"EndMarketingDate": "20200801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Deb USA, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-08-04",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "33342-175-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-175-07) ",
"NDC11Code": "33342-0175-07",
"ProductNDC": "33342-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204801",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "40; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230602",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension [see Dosage and Administration (2)]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Olmesartan medoxomil and hydrochlorothiazide tablets may be used alone, or in combination with other antihypertensive drugs. Limitations of Use Olmesartan medoxomil and hydrochlorothiazide tablets is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, USP and a thiazide diuretic, hydrochlorothiazide (HCTZ), USP. Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide, USP is slightly soluble in water but freely soluble in sodium hydroxide solution. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil, USP combined with 12.5 mg of hydrochlorothiazide, USP or 40 mg of olmesartan medoxomil, USP combined with 25 mg of hydrochlorothiazide, USP. Inactive ingredients include: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, talc, titanium dioxide, iron oxide yellow and iron oxide red."
},
{
"NDCCode": "53217-175-07",
"PackageDescription": "7 TABLET in 1 BOTTLE (53217-175-07)",
"NDC11Code": "53217-0175-07",
"ProductNDC": "53217-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzphetamine Hydrochloride",
"NonProprietaryName": "Benzphetamine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100907",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040747",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "BENZPHETAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use such as those described below. Benzphetamine hydrochloride tablets are indicated for use as monotherapy only.",
"Description": "Benzphetamine hydrochloride tablets 50 mg contain the anorectic agent benzphetamine hydrochloride. Benzphetamine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benzphetamine hydrochloride is d-N, α-Dimethyl-N-(phenylmethyl)- benzeneethanamine hydrochloride and its molecular weight is 275.82. The structural formula (dextro form) is represented below. Each Benzphetamine hydrochloride tablet for oral administration, contains 50 mg of benzphetamine hydrochloride. Inactive Ingredients: Calcium Stearate, Polyethylene Glycol, FD&C Yellow No. 6, Lactose Anhydrous, Sorbitol."
},
{
"NDCCode": "61734-010-07",
"PackageDescription": "175 mL in 1 BOTTLE, PUMP (61734-010-07) ",
"NDC11Code": "61734-0010-07",
"ProductNDC": "61734-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrogen Peroxide",
"NonProprietaryName": "Hydrogen Peroxide",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141008",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Delon Laboratories (1990) Ltd",
"SubstanceName": "HYDROGEN PEROXIDE",
"StrengthNumber": "3",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20141008",
"EndMarketingDatePackage": "20191031",
"SamplePackage": "N"
},
{
"NDCCode": "64220-175-07",
"PackageDescription": "20 kg in 1 DRUM (64220-175-07)",
"NDC11Code": "64220-0175-07",
"ProductNDC": "64220-175",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Fingolimod Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140301",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Zhejiang Huahai Pharmaceutical Co., Ltd.",
"SubstanceName": "FINGOLIMOD HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "71919-175-07",
"PackageDescription": "15 mL in 1 VIAL, GLASS (71919-175-07) ",
"NDC11Code": "71919-0175-07",
"ProductNDC": "71919-175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cephalanthus Occidentalis",
"NonProprietaryName": "Cephalanthus Occidentalis Bark",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131212",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CEPHALANTHUS OCCIDENTALIS BARK",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20131212",
"SamplePackage": "N"
},
{
"NDCCode": "74161-175-07",
"PackageDescription": "500 mL in 1 BOTTLE (74161-175-07) ",
"NDC11Code": "74161-0175-07",
"ProductNDC": "74161-175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Solquim SA DE CV",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200522",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "83602-175-07",
"PackageDescription": "7 BAG in 1 BOX (83602-175-07) / 1 PATCH in 1 BAG / 21 g in 1 PATCH",
"NDC11Code": "83602-0175-07",
"ProductNDC": "83602-175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocaine Pain Relief Gel-patch",
"NonProprietaryName": "Lidocaine And Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.",
"SubstanceName": "MENTHOL; LIDOCAINE",
"StrengthNumber": ".01; .04",
"StrengthUnit": "g/g; g/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260716",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, neck, shoulders, elbows."
},
{
"NDCCode": "50242-038-61",
"PackageDescription": "1 KIT in 1 CARTON (50242-038-61) * 10 mL in 1 VIAL, SINGLE-USE * 10 mL in 1 VIAL, SINGLE-USE * 3 APPLICATOR in 1 PACKET > .7 mL in 1 APPLICATOR",
"NDC11Code": "50242-0038-61",
"ProductNDC": "50242-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tnkase",
"NonProprietaryName": "Tenecteplase",
"DosageFormName": "KIT",
"StartMarketingDate": "20000602",
"EndMarketingDate": "20140630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103909",
"LabelerName": "Genentech, Inc.",
"Status": "Deprecated",
"LastUpdate": "2014-07-07"
},
{
"NDCCode": "50242-070-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50242-070-01) / 40 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0070-01",
"ProductNDC": "50242-070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gazyva",
"NonProprietaryName": "Obinutuzumab",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20131101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125486",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "OBINUTUZUMAB",
"StrengthNumber": "1000",
"StrengthUnit": "mg/40mL",
"Pharm_Classes": "CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131101",
"SamplePackage": "N",
"IndicationAndUsage": "GAZYVA is a CD20-directed cytolytic antibody indicated: 1 in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). (1.1, 14), 2 in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containing regimen. (1.2, 14), 3 in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma. (1.2, 14), 4 for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy (1.3, 14), 5 to reduce the risk of relapse in adult and pediatric patients 2 years of age and older with frequently relapsing or steroid dependent childhood-onset idiopathic nephrotic syndrome who are in complete remission. (1.4, 14).",
"Description": "Obinutuzumab is a humanized anti-CD20 monoclonal antibody of the IgG1 subclass. It recognizes a specific epitope of the CD20 molecule found on B cells. The molecular mass of the antibody is approximately 150 kDa. GAZYVA (obinutuzumab) injection is produced by mammalian cell (CHO) suspension culture. GAZYVA was engineered to have reduced fucose content as compared to a typical IgG1 produced in CHO cells. GAZYVA is a sterile, clear, colorless to slightly brown, preservative-free liquid concentrate for intravenous use. GAZYVA is supplied at a concentration of 25 mg/mL in 1,000 mg single-dose vials. Each vial contains in 40 mL: 1,000 mg obinutuzumab, L-histidine (57.6 mg), L-histidine hydrochloride monohydrate (89.6 mg), trehalose dihydrate (3632 mg), and poloxamer 188 (8 mg). The pH is 6.0."
},
{
"NDCCode": "50242-070-86",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50242-070-86) / 40 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0070-86",
"ProductNDC": "50242-070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gazyva",
"NonProprietaryName": "Obinutuzumab",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20131101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125486",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "OBINUTUZUMAB",
"StrengthNumber": "1000",
"StrengthUnit": "mg/40mL",
"Pharm_Classes": "CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131104",
"SamplePackage": "Y",
"IndicationAndUsage": "GAZYVA is a CD20-directed cytolytic antibody indicated: 1 in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). (1.1, 14), 2 in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containing regimen. (1.2, 14), 3 in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma. (1.2, 14), 4 for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy (1.3, 14).",
"Description": "Obinutuzumab is a humanized anti-CD20 monoclonal antibody of the IgG1 subclass. It recognizes a specific epitope of the CD20 molecule found on B cells. The molecular mass of the antibody is approximately 150 kDa. GAZYVA (obinutuzumab) injection is produced by mammalian cell (CHO) suspension culture. GAZYVA was engineered to have reduced fucose content as compared to a typical IgG1 produced in CHO cells. GAZYVA is a sterile, clear, colorless to slightly brown, preservative-free liquid concentrate for intravenous use. GAZYVA is supplied at a concentration of 25 mg/mL in 1,000 mg single-dose vials. Each vial contains in 40 mL: 1,000 mg obinutuzumab, L-histidine (57.6 mg), L-histidine hydrochloride monohydrate (89.6 mg), trehalose dihydrate (3632 mg), and poloxamer 188 (8 mg). The pH is 6.0."
},
{
"NDCCode": "50242-125-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (50242-125-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "50242-0125-01",
"ProductNDC": "50242-125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Columvi",
"NonProprietaryName": "Glofitamab",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230615",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761309",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "GLOFITAMAB",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Bispecific CD20-directed CD3 T Cell Engager [EPC], CD20-directed Antibody Interactions [MoA], CD3 Receptor Agonists [MoA], CD3-directed Antibody Interactions [MoA], Cytochrome P450 Inhibitors [MoA], Increased Cytokine Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230615",
"SamplePackage": "N",
"IndicationAndUsage": "COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
"Description": "Glofitamab-gxbm is a bispecific CD20-directed CD3 T-cell engager. It is a recombinant humanized anti-CD20 anti-CD3ɛ bispecific immunoglobulin G1 (IgG1) monoclonal antibody produced in Chinese hamster ovary (CHO) cells. Glofitamab-gxbm has an approximate molecular weight of 197 kDa. COLUMVI (glofitamab-gxbm) injection is a sterile, preservative-free, colorless, clear solution supplied in single-dose vials for intravenous infusion. COLUMVI is supplied in 2.5 mg/2.5 mL and 10 mg/10 mL single-dose vials at a concentration of 1 mg/mL. Each mL of solution contains 1 mg glofitamab-gxbm, histidine (0.63 mg), histidine hydrochloride monohydrate (3.34 mg), methionine (1.49 mg), polysorbate 20 (0.5 mg), sucrose (82.15 mg), and Water for Injection, USP, at pH 5.5."
},
{
"NDCCode": "50242-127-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (50242-127-01) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "50242-0127-01",
"ProductNDC": "50242-127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Columvi",
"NonProprietaryName": "Glofitamab",
"DosageFormName": "CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230615",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761309",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "GLOFITAMAB",
"StrengthNumber": "10",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Bispecific CD20-directed CD3 T Cell Engager [EPC], CD20-directed Antibody Interactions [MoA], CD3 Receptor Agonists [MoA], CD3-directed Antibody Interactions [MoA], Cytochrome P450 Inhibitors [MoA], Increased Cytokine Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230615",
"SamplePackage": "N",
"IndicationAndUsage": "COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
"Description": "Glofitamab-gxbm is a bispecific CD20-directed CD3 T-cell engager. It is a recombinant humanized anti-CD20 anti-CD3ɛ bispecific immunoglobulin G1 (IgG1) monoclonal antibody produced in Chinese hamster ovary (CHO) cells. Glofitamab-gxbm has an approximate molecular weight of 197 kDa. COLUMVI (glofitamab-gxbm) injection is a sterile, preservative-free, colorless, clear solution supplied in single-dose vials for intravenous infusion. COLUMVI is supplied in 2.5 mg/2.5 mL and 10 mg/10 mL single-dose vials at a concentration of 1 mg/mL. Each mL of solution contains 1 mg glofitamab-gxbm, histidine (0.63 mg), histidine hydrochloride monohydrate (3.34 mg), methionine (1.49 mg), polysorbate 20 (0.5 mg), sucrose (82.15 mg), and Water for Injection, USP, at pH 5.5."
},
{
"NDCCode": "50242-132-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (50242-132-10) > 15 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "50242-0132-10",
"ProductNDC": "50242-132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Herceptin",
"NonProprietaryName": "Trastuzumab",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170210",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103792",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "TRASTUZUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/7.4mL",
"Pharm_Classes": "HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190603",
"SamplePackage": "N",
"IndicationAndUsage": "Herceptin is a HER2/neu receptor antagonist indicated for: 1 The treatment of HER2-overexpressing breast cancer. (1.1,1.2), 2 The treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).",
"Description": "Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Herceptin (trastuzumab) for injection is a sterile, white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each single-dose vial of Herceptin delivers 150 mg trastuzumab, 136.2 mg α,α-trehalose dihydrate, 3.4 mg L-histidine HCl monohydrate, 2.2 mg L-histidine, and 0.6 mg polysorbate 20. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab that delivers 7.15 mL (150 mg trastuzumab), at a pH of approximately 6."
},
{
"NDCCode": "50242-142-01",
"PackageDescription": "1 VIAL in 1 CARTON (50242-142-01) / 30 mL in 1 VIAL",
"NDC11Code": "50242-0142-01",
"ProductNDC": "50242-142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lunsumio",
"NonProprietaryName": "Mosunetuzumab",
"DosageFormName": "CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20221222",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761263",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "MOSUNETUZUMAB",
"StrengthNumber": "30",
"StrengthUnit": "mg/30mL",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221222",
"SamplePackage": "N",
"IndicationAndUsage": "LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (1.1).",
"Description": "Mosunetuzumab-axgb is a bispecific CD20-directed CD3 T-cell engager. It is a humanized monoclonal anti-CD20xCD3 T-cell-dependent bispecific antibody of the immunoglobulin G1 (IgG1) isotype. Mosunetuzumab-axgb is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. The approximate molecular weight is 146 kDa. LUNSUMIO (mosunetuzumab-axgb) injection is a sterile, preservative-free, colorless solution for intravenous use. Each single-dose vial contains a 1 mL solution of mosunetuzumab-axgb (1 mg), acetic acid (0.4 mg), histidine (1.6 mg), methionine (1.5 mg), polysorbate 20 (0.6 mg), sucrose (82.1 mg), and Water for Injection, USP. The pH is 5.8. Each single-dose vial contains a 30 mL solution of mosunetuzumab-axgb (30 mg), acetic acid (12.8 mg), histidine (46.6 mg), methionine (44.8 mg), polysorbate 20 (18 mg), sucrose (2,462.4 mg), and Water for Injection, USP. The pH is 5.8."
},
{
"NDCCode": "50242-159-01",
"PackageDescription": "1 VIAL in 1 CARTON (50242-159-01) / 1 mL in 1 VIAL",
"NDC11Code": "50242-0159-01",
"ProductNDC": "50242-159",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lunsumio",
"NonProprietaryName": "Mosunetuzumab",
"DosageFormName": "CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20221222",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761263",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "MOSUNETUZUMAB",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221222",
"SamplePackage": "N",
"IndicationAndUsage": "LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (1.1).",
"Description": "Mosunetuzumab-axgb is a bispecific CD20-directed CD3 T-cell engager. It is a humanized monoclonal anti-CD20xCD3 T-cell-dependent bispecific antibody of the immunoglobulin G1 (IgG1) isotype. Mosunetuzumab-axgb is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. The approximate molecular weight is 146 kDa. LUNSUMIO (mosunetuzumab-axgb) injection is a sterile, preservative-free, colorless solution for intravenous use. Each single-dose vial contains a 1 mL solution of mosunetuzumab-axgb (1 mg), acetic acid (0.4 mg), histidine (1.6 mg), methionine (1.5 mg), polysorbate 20 (0.6 mg), sucrose (82.1 mg), and Water for Injection, USP. The pH is 5.8. Each single-dose vial contains a 30 mL solution of mosunetuzumab-axgb (30 mg), acetic acid (12.8 mg), histidine (46.6 mg), methionine (44.8 mg), polysorbate 20 (18 mg), sucrose (2,462.4 mg), and Water for Injection, USP. The pH is 5.8."
},
{
"NDCCode": "50242-160-01",
"PackageDescription": "120 L in 1 TANK (50242-160-01) ",
"NDC11Code": "50242-0160-01",
"ProductNDC": "50242-160",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Bevacizumab",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20040226",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Genentech, Inc. (SSF)",
"SubstanceName": "BEVACIZUMAB",
"StrengthNumber": "25",
"StrengthUnit": "g/L",
"Status": "Unfinished",
"LastUpdate": "2022-07-13",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "26-FEB-04"
},
{
"NDCCode": "50242-160-02",
"PackageDescription": "300 L in 1 TANK (50242-160-02) ",
"NDC11Code": "50242-0160-02",
"ProductNDC": "50242-160",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Bevacizumab",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20040226",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Genentech, Inc. (SSF)",
"SubstanceName": "BEVACIZUMAB",
"StrengthNumber": "25",
"StrengthUnit": "g/L",
"Status": "Unfinished",
"LastUpdate": "2022-07-13",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "26-FEB-04"
},
{
"NDCCode": "50242-177-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (50242-177-01) / .5 mL in 1 VIAL, GLASS",
"NDC11Code": "50242-0177-01",
"ProductNDC": "50242-177",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lunsumio Velo",
"NonProprietaryName": "Mosunetuzumab",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251219",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761263",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "MOSUNETUZUMAB",
"StrengthNumber": "5",
"StrengthUnit": "mg/.5mL",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251219",
"SamplePackage": "N",
"IndicationAndUsage": "LUNSUMIO VELO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (1.1).",
"Description": "Mosunetuzumab-axgb is a bispecific CD20-directed CD3 T-cell engager. It is a humanized monoclonal anti-CD20xCD3 T-cell-dependent bispecific antibody of the immunoglobulin G1 (IgG1) isotype. Mosunetuzumab-axgb is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. The approximate molecular weight is 146 kDa. LUNSUMIO VELO (mosunetuzumab-axgb) injection is a sterile, preservative-free, colorless to slightly brownish-yellow solution for subcutaneous use. Each single-dose vial contains a 0.5 mL solution of mosunetuzumab-axgb (5 mg), acetic acid (0.2 mg), histidine (0.8 mg), methionine (0.7 mg), polysorbate 20 (0.3 mg), sucrose (41 mg), and Water for Injection, USP. The pH is 5.8. Each single-dose vial contains a 1 mL solution of mosunetuzumab-axgb (45 mg), acetic acid (0.4 mg), histidine (1.6 mg), methionine (1.5 mg), polysorbate 20 (0.6 mg), sucrose (82.1 mg), and Water for Injection, USP. The pH is 5.8."
},
{
"NDCCode": "50242-201-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (50242-201-01) / 1 mL in 1 VIAL, GLASS",
"NDC11Code": "50242-0201-01",
"ProductNDC": "50242-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lunsumio Velo",
"NonProprietaryName": "Mosunetuzumab",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251219",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761263",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "MOSUNETUZUMAB",
"StrengthNumber": "45",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251219",
"SamplePackage": "N",
"IndicationAndUsage": "LUNSUMIO VELO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (1.1).",
"Description": "Mosunetuzumab-axgb is a bispecific CD20-directed CD3 T-cell engager. It is a humanized monoclonal anti-CD20xCD3 T-cell-dependent bispecific antibody of the immunoglobulin G1 (IgG1) isotype. Mosunetuzumab-axgb is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. The approximate molecular weight is 146 kDa. LUNSUMIO VELO (mosunetuzumab-axgb) injection is a sterile, preservative-free, colorless to slightly brownish-yellow solution for subcutaneous use. Each single-dose vial contains a 0.5 mL solution of mosunetuzumab-axgb (5 mg), acetic acid (0.2 mg), histidine (0.8 mg), methionine (0.7 mg), polysorbate 20 (0.3 mg), sucrose (41 mg), and Water for Injection, USP. The pH is 5.8. Each single-dose vial contains a 1 mL solution of mosunetuzumab-axgb (45 mg), acetic acid (0.4 mg), histidine (1.6 mg), methionine (1.5 mg), polysorbate 20 (0.6 mg), sucrose (82.1 mg), and Water for Injection, USP. The pH is 5.8."
},
{
"NDCCode": "50242-860-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (50242-860-02) > 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "50242-0860-02",
"ProductNDC": "50242-860",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xofluza",
"NonProprietaryName": "Baloxavir Marboxil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181024",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210854",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "BALOXAVIR MARBOXIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20181024",
"EndMarketingDatePackage": "20220630",
"SamplePackage": "N"
},
{
"NDCCode": "50242-860-87",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (50242-860-87) > 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "50242-0860-87",
"ProductNDC": "50242-860",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xofluza",
"NonProprietaryName": "Baloxavir Marboxil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181024",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210854",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "BALOXAVIR MARBOXIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20181024",
"EndMarketingDatePackage": "20220630",
"SamplePackage": "Y"
},
{
"NDCCode": "50242-920-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50242-920-01) / 1 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0920-01",
"ProductNDC": "50242-920",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hemlibra",
"NonProprietaryName": "Emicizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20171116",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761083",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "EMICIZUMAB",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171116",
"SamplePackage": "N",
"IndicationAndUsage": "HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.",
"Description": "Emicizumab-kxwh is a humanized monoclonal modified immunoglobulin G4 (IgG4) bispecific antibody binding factor IXa and factor X. Emicizumab-kxwh has an approximate molecular weight of 145.6 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Emicizumab-kxwh has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII. HEMLIBRA (emicizumab-kxwh) injection is a sterile, preservative-free, colorless to slightly yellow solution for subcutaneous injection supplied in single-dose vials containing emicizumab-kxwh at 12 mg/0.4 mL, 30 mg/mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/mL, or 300 mg/2 mL. Each single-dose 12 mg vial contains a 0.4 mL solution of emicizumab-kxwh (12 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 30 mg vial contains a 1 mL solution of emicizumab-kxwh (30 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 60 mg vial contains a 0.4 mL solution of emicizumab-kxwh (60 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 105 mg vial contains a 0.7 mL solution of emicizumab-kxwh (105 mg), L-arginine (18.3 mg), L-histidine (2.2 mg), and poloxamer 188 (0.4 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 150 mg vial contains a 1 mL solution of emicizumab-kxwh (150 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 300 mg vial contains a 2 mL solution of emicizumab-kxwh (300 mg), L-arginine (52.3 mg), L-histidine (6.2 mg), and poloxamer 188 (1 mg), adjusted to pH 6.0 with L-aspartic acid."
},
{
"NDCCode": "50242-921-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50242-921-01) / .4 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0921-01",
"ProductNDC": "50242-921",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hemlibra",
"NonProprietaryName": "Emicizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20171116",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761083",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "EMICIZUMAB",
"StrengthNumber": "60",
"StrengthUnit": "mg/.4mL",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171116",
"SamplePackage": "N",
"IndicationAndUsage": "HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.",
"Description": "Emicizumab-kxwh is a humanized monoclonal modified immunoglobulin G4 (IgG4) bispecific antibody binding factor IXa and factor X. Emicizumab-kxwh has an approximate molecular weight of 145.6 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Emicizumab-kxwh has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII. HEMLIBRA (emicizumab-kxwh) injection is a sterile, preservative-free, colorless to slightly yellow solution for subcutaneous injection supplied in single-dose vials containing emicizumab-kxwh at 12 mg/0.4 mL, 30 mg/mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/mL, or 300 mg/2 mL. Each single-dose 12 mg vial contains a 0.4 mL solution of emicizumab-kxwh (12 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 30 mg vial contains a 1 mL solution of emicizumab-kxwh (30 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 60 mg vial contains a 0.4 mL solution of emicizumab-kxwh (60 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 105 mg vial contains a 0.7 mL solution of emicizumab-kxwh (105 mg), L-arginine (18.3 mg), L-histidine (2.2 mg), and poloxamer 188 (0.4 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 150 mg vial contains a 1 mL solution of emicizumab-kxwh (150 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 300 mg vial contains a 2 mL solution of emicizumab-kxwh (300 mg), L-arginine (52.3 mg), L-histidine (6.2 mg), and poloxamer 188 (1 mg), adjusted to pH 6.0 with L-aspartic acid."
},
{
"NDCCode": "50242-922-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50242-922-01) / .7 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0922-01",
"ProductNDC": "50242-922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hemlibra",
"NonProprietaryName": "Emicizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20171116",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761083",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "EMICIZUMAB",
"StrengthNumber": "105",
"StrengthUnit": "mg/.7mL",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171116",
"SamplePackage": "N",
"IndicationAndUsage": "HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.",
"Description": "Emicizumab-kxwh is a humanized monoclonal modified immunoglobulin G4 (IgG4) bispecific antibody binding factor IXa and factor X. Emicizumab-kxwh has an approximate molecular weight of 145.6 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Emicizumab-kxwh has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII. HEMLIBRA (emicizumab-kxwh) injection is a sterile, preservative-free, colorless to slightly yellow solution for subcutaneous injection supplied in single-dose vials containing emicizumab-kxwh at 12 mg/0.4 mL, 30 mg/mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/mL, or 300 mg/2 mL. Each single-dose 12 mg vial contains a 0.4 mL solution of emicizumab-kxwh (12 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 30 mg vial contains a 1 mL solution of emicizumab-kxwh (30 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 60 mg vial contains a 0.4 mL solution of emicizumab-kxwh (60 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 105 mg vial contains a 0.7 mL solution of emicizumab-kxwh (105 mg), L-arginine (18.3 mg), L-histidine (2.2 mg), and poloxamer 188 (0.4 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 150 mg vial contains a 1 mL solution of emicizumab-kxwh (150 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 300 mg vial contains a 2 mL solution of emicizumab-kxwh (300 mg), L-arginine (52.3 mg), L-histidine (6.2 mg), and poloxamer 188 (1 mg), adjusted to pH 6.0 with L-aspartic acid."
},
{
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"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50242-923-01) / 1 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0923-01",
"ProductNDC": "50242-923",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hemlibra",
"NonProprietaryName": "Emicizumab",
"DosageFormName": "INJECTION, SOLUTION",
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"LabelerName": "Genentech, Inc.",
"SubstanceName": "EMICIZUMAB",
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"Status": "Active",
"LastUpdate": "2025-07-19",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171116",
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"IndicationAndUsage": "HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.",
"Description": "Emicizumab-kxwh is a humanized monoclonal modified immunoglobulin G4 (IgG4) bispecific antibody binding factor IXa and factor X. Emicizumab-kxwh has an approximate molecular weight of 145.6 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Emicizumab-kxwh has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII. HEMLIBRA (emicizumab-kxwh) injection is a sterile, preservative-free, colorless to slightly yellow solution for subcutaneous injection supplied in single-dose vials containing emicizumab-kxwh at 12 mg/0.4 mL, 30 mg/mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/mL, or 300 mg/2 mL. Each single-dose 12 mg vial contains a 0.4 mL solution of emicizumab-kxwh (12 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 30 mg vial contains a 1 mL solution of emicizumab-kxwh (30 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 60 mg vial contains a 0.4 mL solution of emicizumab-kxwh (60 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 105 mg vial contains a 0.7 mL solution of emicizumab-kxwh (105 mg), L-arginine (18.3 mg), L-histidine (2.2 mg), and poloxamer 188 (0.4 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 150 mg vial contains a 1 mL solution of emicizumab-kxwh (150 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 300 mg vial contains a 2 mL solution of emicizumab-kxwh (300 mg), L-arginine (52.3 mg), L-histidine (6.2 mg), and poloxamer 188 (1 mg), adjusted to pH 6.0 with L-aspartic acid."
},
{
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"ProductNDC": "50242-927",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hemlibra",
"NonProprietaryName": "Emicizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20240131",
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"ApplicationNumber": "BLA761083",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "EMICIZUMAB",
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"LastUpdate": "2025-07-19",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
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"IndicationAndUsage": "HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.",
"Description": "Emicizumab-kxwh is a humanized monoclonal modified immunoglobulin G4 (IgG4) bispecific antibody binding factor IXa and factor X. Emicizumab-kxwh has an approximate molecular weight of 145.6 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Emicizumab-kxwh has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII. HEMLIBRA (emicizumab-kxwh) injection is a sterile, preservative-free, colorless to slightly yellow solution for subcutaneous injection supplied in single-dose vials containing emicizumab-kxwh at 12 mg/0.4 mL, 30 mg/mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/mL, or 300 mg/2 mL. Each single-dose 12 mg vial contains a 0.4 mL solution of emicizumab-kxwh (12 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 30 mg vial contains a 1 mL solution of emicizumab-kxwh (30 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 60 mg vial contains a 0.4 mL solution of emicizumab-kxwh (60 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 105 mg vial contains a 0.7 mL solution of emicizumab-kxwh (105 mg), L-arginine (18.3 mg), L-histidine (2.2 mg), and poloxamer 188 (0.4 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 150 mg vial contains a 1 mL solution of emicizumab-kxwh (150 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 300 mg vial contains a 2 mL solution of emicizumab-kxwh (300 mg), L-arginine (52.3 mg), L-histidine (6.2 mg), and poloxamer 188 (1 mg), adjusted to pH 6.0 with L-aspartic acid."
},
{
"NDCCode": "50242-930-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50242-930-01) / 2 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0930-01",
"ProductNDC": "50242-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hemlibra",
"NonProprietaryName": "Emicizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230316",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761083",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "EMICIZUMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/2mL",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230316",
"SamplePackage": "N",
"IndicationAndUsage": "HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.",
"Description": "Emicizumab-kxwh is a humanized monoclonal modified immunoglobulin G4 (IgG4) bispecific antibody binding factor IXa and factor X. Emicizumab-kxwh has an approximate molecular weight of 145.6 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Emicizumab-kxwh has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII. HEMLIBRA (emicizumab-kxwh) injection is a sterile, preservative-free, colorless to slightly yellow solution for subcutaneous injection supplied in single-dose vials containing emicizumab-kxwh at 12 mg/0.4 mL, 30 mg/mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/mL, or 300 mg/2 mL. Each single-dose 12 mg vial contains a 0.4 mL solution of emicizumab-kxwh (12 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 30 mg vial contains a 1 mL solution of emicizumab-kxwh (30 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 60 mg vial contains a 0.4 mL solution of emicizumab-kxwh (60 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 105 mg vial contains a 0.7 mL solution of emicizumab-kxwh (105 mg), L-arginine (18.3 mg), L-histidine (2.2 mg), and poloxamer 188 (0.4 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 150 mg vial contains a 1 mL solution of emicizumab-kxwh (150 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 300 mg vial contains a 2 mL solution of emicizumab-kxwh (300 mg), L-arginine (52.3 mg), L-histidine (6.2 mg), and poloxamer 188 (1 mg), adjusted to pH 6.0 with L-aspartic acid."
},
{
"NDCCode": "50242-931-01",
"PackageDescription": "120 L in 1 TANK (50242-931-01)",
"NDC11Code": "50242-0931-01",
"ProductNDC": "50242-931",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Somatropin",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "19951229",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "SOMATROPIN",
"StrengthNumber": "5",
"StrengthUnit": "g/2L",
"Status": "Unfinished",
"LastUpdate": "2018-07-24",
"ListingRecordCertifiedThrough": "20191231"
}
]
}
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<NDCList>
<NDC>
<NDCCode>50242-175-07</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (50242-175-07) / 80 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>50242-0175-07</NDC11Code>
<ProductNDC>50242-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Evrysdi</ProprietaryName>
<NonProprietaryName>Risdiplam</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200807</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213535</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>RISDIPLAM</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Protein Synthesis [PE], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA], Survival of Motor Neuron 2 Splicing Modifier [EPC], Survival of Motor Neuron 2 Splicing Modifiers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EVRYSDI is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.</IndicationAndUsage>
<Description>EVRYSDI for oral solution and EVRYSDI tablets for oral use contain risdiplam, which is a survival of motor neuron 2 (SMN2)-directed RNA splicing modifier. The chemical name of risdiplam is 7-(4,7-diazaspiro[2.5]octan-7-yl)-2-(2,8 dimethylimidazo[1,2-b]pyridazin-6-yl)pyrido-4H-[1,2-a]pyrimidin-4-one. Risdiplam has a molecular weight of 401.46 g/mol. Risdiplam demonstrates pH-dependent aqueous solubility; the greatest solubility is at low pH, and solubility decreases with increasing pH. Risdiplam has a pKa1 of 3.78 (base) and pKa2 of 6.62 (base). The molecular formula of risdiplam is C22H23N7O and the chemical structure is shown below. EVRYSDI for oral solution is supplied as a powder in an amber glass bottle. Each bottle contains 60 mg of risdiplam. The inactive ingredients of EVRYSDI are: ascorbic acid, disodium edetate dihydrate, isomalt, mannitol, polyethylene glycol 6000, sodium benzoate, strawberry flavor, sucralose, and tartaric acid. The powder is constituted with purified water to yield 60 mg/80 mL (0.75 mg/mL) of risdiplam after constitution [see Dosage and Administration (2.4)]. Each EVRYSDI tablet contains 5 mg of risdiplam. The inactive ingredients of EVRYSDI tablet are colloidal silicon dioxide, crospovidone, mannitol, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol, sodium stearyl fumarate, strawberry flavor, talc, tartaric acid, titanium dioxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>11084-175-07</NDCCode>
<PackageDescription>2000 mL in 1 BOTTLE, PLASTIC (11084-175-07)</PackageDescription>
<NDC11Code>11084-0175-07</NDC11Code>
<ProductNDC>11084-175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sbs Ultragreen</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130725</StartMarketingDate>
<EndMarketingDate>20200801</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Deb USA, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>33342-175-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-175-07) </PackageDescription>
<NDC11Code>33342-0175-07</NDC11Code>
<ProductNDC>33342-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204801</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>40; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension [see Dosage and Administration (2)]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Olmesartan medoxomil and hydrochlorothiazide tablets may be used alone, or in combination with other antihypertensive drugs. Limitations of Use Olmesartan medoxomil and hydrochlorothiazide tablets is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, USP and a thiazide diuretic, hydrochlorothiazide (HCTZ), USP. Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide, USP is slightly soluble in water but freely soluble in sodium hydroxide solution. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil, USP combined with 12.5 mg of hydrochlorothiazide, USP or 40 mg of olmesartan medoxomil, USP combined with 25 mg of hydrochlorothiazide, USP. Inactive ingredients include: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, talc, titanium dioxide, iron oxide yellow and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>53217-175-07</NDCCode>
<PackageDescription>7 TABLET in 1 BOTTLE (53217-175-07)</PackageDescription>
<NDC11Code>53217-0175-07</NDC11Code>
<ProductNDC>53217-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzphetamine Hydrochloride</ProprietaryName>
<NonProprietaryName>Benzphetamine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100907</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040747</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>BENZPHETAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use such as those described below. Benzphetamine hydrochloride tablets are indicated for use as monotherapy only.</IndicationAndUsage>
<Description>Benzphetamine hydrochloride tablets 50 mg contain the anorectic agent benzphetamine hydrochloride. Benzphetamine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benzphetamine hydrochloride is d-N, α-Dimethyl-N-(phenylmethyl)- benzeneethanamine hydrochloride and its molecular weight is 275.82. The structural formula (dextro form) is represented below. Each Benzphetamine hydrochloride tablet for oral administration, contains 50 mg of benzphetamine hydrochloride. Inactive Ingredients: Calcium Stearate, Polyethylene Glycol, FD&C Yellow No. 6, Lactose Anhydrous, Sorbitol.</Description>
</NDC>
<NDC>
<NDCCode>61734-010-07</NDCCode>
<PackageDescription>175 mL in 1 BOTTLE, PUMP (61734-010-07) </PackageDescription>
<NDC11Code>61734-0010-07</NDC11Code>
<ProductNDC>61734-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrogen Peroxide</ProprietaryName>
<NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141008</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Delon Laboratories (1990) Ltd</LabelerName>
<SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-11-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141008</StartMarketingDatePackage>
<EndMarketingDatePackage>20191031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64220-175-07</NDCCode>
<PackageDescription>20 kg in 1 DRUM (64220-175-07)</PackageDescription>
<NDC11Code>64220-0175-07</NDC11Code>
<ProductNDC>64220-175</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Fingolimod Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140301</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Zhejiang Huahai Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>FINGOLIMOD HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71919-175-07</NDCCode>
<PackageDescription>15 mL in 1 VIAL, GLASS (71919-175-07) </PackageDescription>
<NDC11Code>71919-0175-07</NDC11Code>
<ProductNDC>71919-175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cephalanthus Occidentalis</ProprietaryName>
<NonProprietaryName>Cephalanthus Occidentalis Bark</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131212</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CEPHALANTHUS OCCIDENTALIS BARK</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>74161-175-07</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (74161-175-07) </PackageDescription>
<NDC11Code>74161-0175-07</NDC11Code>
<ProductNDC>74161-175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Solquim SA DE CV</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83602-175-07</NDCCode>
<PackageDescription>7 BAG in 1 BOX (83602-175-07) / 1 PATCH in 1 BAG / 21 g in 1 PATCH</PackageDescription>
<NDC11Code>83602-0175-07</NDC11Code>
<ProductNDC>83602-175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Pain Relief Gel-patch</ProprietaryName>
<NonProprietaryName>Lidocaine And Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.</LabelerName>
<SubstanceName>MENTHOL; LIDOCAINE</SubstanceName>
<StrengthNumber>.01; .04</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, neck, shoulders, elbows.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50242-038-61</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (50242-038-61) * 10 mL in 1 VIAL, SINGLE-USE * 10 mL in 1 VIAL, SINGLE-USE * 3 APPLICATOR in 1 PACKET > .7 mL in 1 APPLICATOR</PackageDescription>
<NDC11Code>50242-0038-61</NDC11Code>
<ProductNDC>50242-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tnkase</ProprietaryName>
<NonProprietaryName>Tenecteplase</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20000602</StartMarketingDate>
<EndMarketingDate>20140630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103909</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2014-07-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>50242-070-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50242-070-01) / 40 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0070-01</NDC11Code>
<ProductNDC>50242-070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gazyva</ProprietaryName>
<NonProprietaryName>Obinutuzumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20131101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125486</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>OBINUTUZUMAB</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/40mL</StrengthUnit>
<Pharm_Classes>CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GAZYVA is a CD20-directed cytolytic antibody indicated: 1 in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). (1.1, 14), 2 in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containing regimen. (1.2, 14), 3 in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma. (1.2, 14), 4 for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy (1.3, 14), 5 to reduce the risk of relapse in adult and pediatric patients 2 years of age and older with frequently relapsing or steroid dependent childhood-onset idiopathic nephrotic syndrome who are in complete remission. (1.4, 14).</IndicationAndUsage>
<Description>Obinutuzumab is a humanized anti-CD20 monoclonal antibody of the IgG1 subclass. It recognizes a specific epitope of the CD20 molecule found on B cells. The molecular mass of the antibody is approximately 150 kDa. GAZYVA (obinutuzumab) injection is produced by mammalian cell (CHO) suspension culture. GAZYVA was engineered to have reduced fucose content as compared to a typical IgG1 produced in CHO cells. GAZYVA is a sterile, clear, colorless to slightly brown, preservative-free liquid concentrate for intravenous use. GAZYVA is supplied at a concentration of 25 mg/mL in 1,000 mg single-dose vials. Each vial contains in 40 mL: 1,000 mg obinutuzumab, L-histidine (57.6 mg), L-histidine hydrochloride monohydrate (89.6 mg), trehalose dihydrate (3632 mg), and poloxamer 188 (8 mg). The pH is 6.0.</Description>
</NDC>
<NDC>
<NDCCode>50242-070-86</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50242-070-86) / 40 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0070-86</NDC11Code>
<ProductNDC>50242-070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gazyva</ProprietaryName>
<NonProprietaryName>Obinutuzumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20131101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125486</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>OBINUTUZUMAB</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/40mL</StrengthUnit>
<Pharm_Classes>CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131104</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>GAZYVA is a CD20-directed cytolytic antibody indicated: 1 in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). (1.1, 14), 2 in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containing regimen. (1.2, 14), 3 in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma. (1.2, 14), 4 for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy (1.3, 14).</IndicationAndUsage>
<Description>Obinutuzumab is a humanized anti-CD20 monoclonal antibody of the IgG1 subclass. It recognizes a specific epitope of the CD20 molecule found on B cells. The molecular mass of the antibody is approximately 150 kDa. GAZYVA (obinutuzumab) injection is produced by mammalian cell (CHO) suspension culture. GAZYVA was engineered to have reduced fucose content as compared to a typical IgG1 produced in CHO cells. GAZYVA is a sterile, clear, colorless to slightly brown, preservative-free liquid concentrate for intravenous use. GAZYVA is supplied at a concentration of 25 mg/mL in 1,000 mg single-dose vials. Each vial contains in 40 mL: 1,000 mg obinutuzumab, L-histidine (57.6 mg), L-histidine hydrochloride monohydrate (89.6 mg), trehalose dihydrate (3632 mg), and poloxamer 188 (8 mg). The pH is 6.0.</Description>
</NDC>
<NDC>
<NDCCode>50242-125-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (50242-125-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>50242-0125-01</NDC11Code>
<ProductNDC>50242-125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Columvi</ProprietaryName>
<NonProprietaryName>Glofitamab</NonProprietaryName>
<DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230615</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761309</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>GLOFITAMAB</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Pharm_Classes>Bispecific CD20-directed CD3 T Cell Engager [EPC], CD20-directed Antibody Interactions [MoA], CD3 Receptor Agonists [MoA], CD3-directed Antibody Interactions [MoA], Cytochrome P450 Inhibitors [MoA], Increased Cytokine Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
<Description>Glofitamab-gxbm is a bispecific CD20-directed CD3 T-cell engager. It is a recombinant humanized anti-CD20 anti-CD3ɛ bispecific immunoglobulin G1 (IgG1) monoclonal antibody produced in Chinese hamster ovary (CHO) cells. Glofitamab-gxbm has an approximate molecular weight of 197 kDa. COLUMVI (glofitamab-gxbm) injection is a sterile, preservative-free, colorless, clear solution supplied in single-dose vials for intravenous infusion. COLUMVI is supplied in 2.5 mg/2.5 mL and 10 mg/10 mL single-dose vials at a concentration of 1 mg/mL. Each mL of solution contains 1 mg glofitamab-gxbm, histidine (0.63 mg), histidine hydrochloride monohydrate (3.34 mg), methionine (1.49 mg), polysorbate 20 (0.5 mg), sucrose (82.15 mg), and Water for Injection, USP, at pH 5.5.</Description>
</NDC>
<NDC>
<NDCCode>50242-127-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (50242-127-01) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>50242-0127-01</NDC11Code>
<ProductNDC>50242-127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Columvi</ProprietaryName>
<NonProprietaryName>Glofitamab</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230615</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761309</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>GLOFITAMAB</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Bispecific CD20-directed CD3 T Cell Engager [EPC], CD20-directed Antibody Interactions [MoA], CD3 Receptor Agonists [MoA], CD3-directed Antibody Interactions [MoA], Cytochrome P450 Inhibitors [MoA], Increased Cytokine Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
<Description>Glofitamab-gxbm is a bispecific CD20-directed CD3 T-cell engager. It is a recombinant humanized anti-CD20 anti-CD3ɛ bispecific immunoglobulin G1 (IgG1) monoclonal antibody produced in Chinese hamster ovary (CHO) cells. Glofitamab-gxbm has an approximate molecular weight of 197 kDa. COLUMVI (glofitamab-gxbm) injection is a sterile, preservative-free, colorless, clear solution supplied in single-dose vials for intravenous infusion. COLUMVI is supplied in 2.5 mg/2.5 mL and 10 mg/10 mL single-dose vials at a concentration of 1 mg/mL. Each mL of solution contains 1 mg glofitamab-gxbm, histidine (0.63 mg), histidine hydrochloride monohydrate (3.34 mg), methionine (1.49 mg), polysorbate 20 (0.5 mg), sucrose (82.15 mg), and Water for Injection, USP, at pH 5.5.</Description>
</NDC>
<NDC>
<NDCCode>50242-132-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (50242-132-10) > 15 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>50242-0132-10</NDC11Code>
<ProductNDC>50242-132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Herceptin</ProprietaryName>
<NonProprietaryName>Trastuzumab</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170210</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103792</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>TRASTUZUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/7.4mL</StrengthUnit>
<Pharm_Classes>HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Herceptin is a HER2/neu receptor antagonist indicated for: 1 The treatment of HER2-overexpressing breast cancer. (1.1,1.2), 2 The treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).</IndicationAndUsage>
<Description>Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Herceptin (trastuzumab) for injection is a sterile, white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each single-dose vial of Herceptin delivers 150 mg trastuzumab, 136.2 mg α,α-trehalose dihydrate, 3.4 mg L-histidine HCl monohydrate, 2.2 mg L-histidine, and 0.6 mg polysorbate 20. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab that delivers 7.15 mL (150 mg trastuzumab), at a pH of approximately 6.</Description>
</NDC>
<NDC>
<NDCCode>50242-142-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (50242-142-01) / 30 mL in 1 VIAL</PackageDescription>
<NDC11Code>50242-0142-01</NDC11Code>
<ProductNDC>50242-142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lunsumio</ProprietaryName>
<NonProprietaryName>Mosunetuzumab</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20221222</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761263</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>MOSUNETUZUMAB</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (1.1).</IndicationAndUsage>
<Description>Mosunetuzumab-axgb is a bispecific CD20-directed CD3 T-cell engager. It is a humanized monoclonal anti-CD20xCD3 T-cell-dependent bispecific antibody of the immunoglobulin G1 (IgG1) isotype. Mosunetuzumab-axgb is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. The approximate molecular weight is 146 kDa. LUNSUMIO (mosunetuzumab-axgb) injection is a sterile, preservative-free, colorless solution for intravenous use. Each single-dose vial contains a 1 mL solution of mosunetuzumab-axgb (1 mg), acetic acid (0.4 mg), histidine (1.6 mg), methionine (1.5 mg), polysorbate 20 (0.6 mg), sucrose (82.1 mg), and Water for Injection, USP. The pH is 5.8. Each single-dose vial contains a 30 mL solution of mosunetuzumab-axgb (30 mg), acetic acid (12.8 mg), histidine (46.6 mg), methionine (44.8 mg), polysorbate 20 (18 mg), sucrose (2,462.4 mg), and Water for Injection, USP. The pH is 5.8.</Description>
</NDC>
<NDC>
<NDCCode>50242-159-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (50242-159-01) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>50242-0159-01</NDC11Code>
<ProductNDC>50242-159</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lunsumio</ProprietaryName>
<NonProprietaryName>Mosunetuzumab</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20221222</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761263</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>MOSUNETUZUMAB</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (1.1).</IndicationAndUsage>
<Description>Mosunetuzumab-axgb is a bispecific CD20-directed CD3 T-cell engager. It is a humanized monoclonal anti-CD20xCD3 T-cell-dependent bispecific antibody of the immunoglobulin G1 (IgG1) isotype. Mosunetuzumab-axgb is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. The approximate molecular weight is 146 kDa. LUNSUMIO (mosunetuzumab-axgb) injection is a sterile, preservative-free, colorless solution for intravenous use. Each single-dose vial contains a 1 mL solution of mosunetuzumab-axgb (1 mg), acetic acid (0.4 mg), histidine (1.6 mg), methionine (1.5 mg), polysorbate 20 (0.6 mg), sucrose (82.1 mg), and Water for Injection, USP. The pH is 5.8. Each single-dose vial contains a 30 mL solution of mosunetuzumab-axgb (30 mg), acetic acid (12.8 mg), histidine (46.6 mg), methionine (44.8 mg), polysorbate 20 (18 mg), sucrose (2,462.4 mg), and Water for Injection, USP. The pH is 5.8.</Description>
</NDC>
<NDC>
<NDCCode>50242-160-01</NDCCode>
<PackageDescription>120 L in 1 TANK (50242-160-01) </PackageDescription>
<NDC11Code>50242-0160-01</NDC11Code>
<ProductNDC>50242-160</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Bevacizumab</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20040226</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Genentech, Inc. (SSF)</LabelerName>
<SubstanceName>BEVACIZUMAB</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>g/L</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-07-13</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>26-FEB-04</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>50242-160-02</NDCCode>
<PackageDescription>300 L in 1 TANK (50242-160-02) </PackageDescription>
<NDC11Code>50242-0160-02</NDC11Code>
<ProductNDC>50242-160</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Bevacizumab</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20040226</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Genentech, Inc. (SSF)</LabelerName>
<SubstanceName>BEVACIZUMAB</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>g/L</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-07-13</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>26-FEB-04</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>50242-177-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (50242-177-01) / .5 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>50242-0177-01</NDC11Code>
<ProductNDC>50242-177</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lunsumio Velo</ProprietaryName>
<NonProprietaryName>Mosunetuzumab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20251219</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761263</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>MOSUNETUZUMAB</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUNSUMIO VELO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (1.1).</IndicationAndUsage>
<Description>Mosunetuzumab-axgb is a bispecific CD20-directed CD3 T-cell engager. It is a humanized monoclonal anti-CD20xCD3 T-cell-dependent bispecific antibody of the immunoglobulin G1 (IgG1) isotype. Mosunetuzumab-axgb is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. The approximate molecular weight is 146 kDa. LUNSUMIO VELO (mosunetuzumab-axgb) injection is a sterile, preservative-free, colorless to slightly brownish-yellow solution for subcutaneous use. Each single-dose vial contains a 0.5 mL solution of mosunetuzumab-axgb (5 mg), acetic acid (0.2 mg), histidine (0.8 mg), methionine (0.7 mg), polysorbate 20 (0.3 mg), sucrose (41 mg), and Water for Injection, USP. The pH is 5.8. Each single-dose vial contains a 1 mL solution of mosunetuzumab-axgb (45 mg), acetic acid (0.4 mg), histidine (1.6 mg), methionine (1.5 mg), polysorbate 20 (0.6 mg), sucrose (82.1 mg), and Water for Injection, USP. The pH is 5.8.</Description>
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<NDC>
<NDCCode>50242-201-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (50242-201-01) / 1 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>50242-0201-01</NDC11Code>
<ProductNDC>50242-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lunsumio Velo</ProprietaryName>
<NonProprietaryName>Mosunetuzumab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20251219</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761263</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>MOSUNETUZUMAB</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUNSUMIO VELO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (1.1).</IndicationAndUsage>
<Description>Mosunetuzumab-axgb is a bispecific CD20-directed CD3 T-cell engager. It is a humanized monoclonal anti-CD20xCD3 T-cell-dependent bispecific antibody of the immunoglobulin G1 (IgG1) isotype. Mosunetuzumab-axgb is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. The approximate molecular weight is 146 kDa. LUNSUMIO VELO (mosunetuzumab-axgb) injection is a sterile, preservative-free, colorless to slightly brownish-yellow solution for subcutaneous use. Each single-dose vial contains a 0.5 mL solution of mosunetuzumab-axgb (5 mg), acetic acid (0.2 mg), histidine (0.8 mg), methionine (0.7 mg), polysorbate 20 (0.3 mg), sucrose (41 mg), and Water for Injection, USP. The pH is 5.8. Each single-dose vial contains a 1 mL solution of mosunetuzumab-axgb (45 mg), acetic acid (0.4 mg), histidine (1.6 mg), methionine (1.5 mg), polysorbate 20 (0.6 mg), sucrose (82.1 mg), and Water for Injection, USP. The pH is 5.8.</Description>
</NDC>
<NDC>
<NDCCode>50242-860-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (50242-860-02) > 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50242-0860-02</NDC11Code>
<ProductNDC>50242-860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xofluza</ProprietaryName>
<NonProprietaryName>Baloxavir Marboxil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181024</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210854</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>BALOXAVIR MARBOXIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181024</StartMarketingDatePackage>
<EndMarketingDatePackage>20220630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50242-860-87</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (50242-860-87) > 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50242-0860-87</NDC11Code>
<ProductNDC>50242-860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xofluza</ProprietaryName>
<NonProprietaryName>Baloxavir Marboxil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181024</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210854</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>BALOXAVIR MARBOXIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181024</StartMarketingDatePackage>
<EndMarketingDatePackage>20220630</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>50242-920-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50242-920-01) / 1 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0920-01</NDC11Code>
<ProductNDC>50242-920</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hemlibra</ProprietaryName>
<NonProprietaryName>Emicizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20171116</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761083</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>EMICIZUMAB</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.</IndicationAndUsage>
<Description>Emicizumab-kxwh is a humanized monoclonal modified immunoglobulin G4 (IgG4) bispecific antibody binding factor IXa and factor X. Emicizumab-kxwh has an approximate molecular weight of 145.6 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Emicizumab-kxwh has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII. HEMLIBRA (emicizumab-kxwh) injection is a sterile, preservative-free, colorless to slightly yellow solution for subcutaneous injection supplied in single-dose vials containing emicizumab-kxwh at 12 mg/0.4 mL, 30 mg/mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/mL, or 300 mg/2 mL. Each single-dose 12 mg vial contains a 0.4 mL solution of emicizumab-kxwh (12 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 30 mg vial contains a 1 mL solution of emicizumab-kxwh (30 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 60 mg vial contains a 0.4 mL solution of emicizumab-kxwh (60 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 105 mg vial contains a 0.7 mL solution of emicizumab-kxwh (105 mg), L-arginine (18.3 mg), L-histidine (2.2 mg), and poloxamer 188 (0.4 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 150 mg vial contains a 1 mL solution of emicizumab-kxwh (150 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 300 mg vial contains a 2 mL solution of emicizumab-kxwh (300 mg), L-arginine (52.3 mg), L-histidine (6.2 mg), and poloxamer 188 (1 mg), adjusted to pH 6.0 with L-aspartic acid.</Description>
</NDC>
<NDC>
<NDCCode>50242-921-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50242-921-01) / .4 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0921-01</NDC11Code>
<ProductNDC>50242-921</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hemlibra</ProprietaryName>
<NonProprietaryName>Emicizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20171116</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761083</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>EMICIZUMAB</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/.4mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.</IndicationAndUsage>
<Description>Emicizumab-kxwh is a humanized monoclonal modified immunoglobulin G4 (IgG4) bispecific antibody binding factor IXa and factor X. Emicizumab-kxwh has an approximate molecular weight of 145.6 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Emicizumab-kxwh has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII. HEMLIBRA (emicizumab-kxwh) injection is a sterile, preservative-free, colorless to slightly yellow solution for subcutaneous injection supplied in single-dose vials containing emicizumab-kxwh at 12 mg/0.4 mL, 30 mg/mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/mL, or 300 mg/2 mL. Each single-dose 12 mg vial contains a 0.4 mL solution of emicizumab-kxwh (12 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 30 mg vial contains a 1 mL solution of emicizumab-kxwh (30 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 60 mg vial contains a 0.4 mL solution of emicizumab-kxwh (60 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 105 mg vial contains a 0.7 mL solution of emicizumab-kxwh (105 mg), L-arginine (18.3 mg), L-histidine (2.2 mg), and poloxamer 188 (0.4 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 150 mg vial contains a 1 mL solution of emicizumab-kxwh (150 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 300 mg vial contains a 2 mL solution of emicizumab-kxwh (300 mg), L-arginine (52.3 mg), L-histidine (6.2 mg), and poloxamer 188 (1 mg), adjusted to pH 6.0 with L-aspartic acid.</Description>
</NDC>
<NDC>
<NDCCode>50242-922-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50242-922-01) / .7 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0922-01</NDC11Code>
<ProductNDC>50242-922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hemlibra</ProprietaryName>
<NonProprietaryName>Emicizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20171116</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761083</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>EMICIZUMAB</SubstanceName>
<StrengthNumber>105</StrengthNumber>
<StrengthUnit>mg/.7mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.</IndicationAndUsage>
<Description>Emicizumab-kxwh is a humanized monoclonal modified immunoglobulin G4 (IgG4) bispecific antibody binding factor IXa and factor X. Emicizumab-kxwh has an approximate molecular weight of 145.6 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Emicizumab-kxwh has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII. HEMLIBRA (emicizumab-kxwh) injection is a sterile, preservative-free, colorless to slightly yellow solution for subcutaneous injection supplied in single-dose vials containing emicizumab-kxwh at 12 mg/0.4 mL, 30 mg/mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/mL, or 300 mg/2 mL. Each single-dose 12 mg vial contains a 0.4 mL solution of emicizumab-kxwh (12 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 30 mg vial contains a 1 mL solution of emicizumab-kxwh (30 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 60 mg vial contains a 0.4 mL solution of emicizumab-kxwh (60 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 105 mg vial contains a 0.7 mL solution of emicizumab-kxwh (105 mg), L-arginine (18.3 mg), L-histidine (2.2 mg), and poloxamer 188 (0.4 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 150 mg vial contains a 1 mL solution of emicizumab-kxwh (150 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 300 mg vial contains a 2 mL solution of emicizumab-kxwh (300 mg), L-arginine (52.3 mg), L-histidine (6.2 mg), and poloxamer 188 (1 mg), adjusted to pH 6.0 with L-aspartic acid.</Description>
</NDC>
<NDC>
<NDCCode>50242-923-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50242-923-01) / 1 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0923-01</NDC11Code>
<ProductNDC>50242-923</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hemlibra</ProprietaryName>
<NonProprietaryName>Emicizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20171116</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761083</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>EMICIZUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.</IndicationAndUsage>
<Description>Emicizumab-kxwh is a humanized monoclonal modified immunoglobulin G4 (IgG4) bispecific antibody binding factor IXa and factor X. Emicizumab-kxwh has an approximate molecular weight of 145.6 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Emicizumab-kxwh has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII. HEMLIBRA (emicizumab-kxwh) injection is a sterile, preservative-free, colorless to slightly yellow solution for subcutaneous injection supplied in single-dose vials containing emicizumab-kxwh at 12 mg/0.4 mL, 30 mg/mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/mL, or 300 mg/2 mL. Each single-dose 12 mg vial contains a 0.4 mL solution of emicizumab-kxwh (12 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 30 mg vial contains a 1 mL solution of emicizumab-kxwh (30 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 60 mg vial contains a 0.4 mL solution of emicizumab-kxwh (60 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 105 mg vial contains a 0.7 mL solution of emicizumab-kxwh (105 mg), L-arginine (18.3 mg), L-histidine (2.2 mg), and poloxamer 188 (0.4 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 150 mg vial contains a 1 mL solution of emicizumab-kxwh (150 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 300 mg vial contains a 2 mL solution of emicizumab-kxwh (300 mg), L-arginine (52.3 mg), L-histidine (6.2 mg), and poloxamer 188 (1 mg), adjusted to pH 6.0 with L-aspartic acid.</Description>
</NDC>
<NDC>
<NDCCode>50242-927-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50242-927-01) / .4 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0927-01</NDC11Code>
<ProductNDC>50242-927</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hemlibra</ProprietaryName>
<NonProprietaryName>Emicizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240131</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761083</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>EMICIZUMAB</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/.4mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.</IndicationAndUsage>
<Description>Emicizumab-kxwh is a humanized monoclonal modified immunoglobulin G4 (IgG4) bispecific antibody binding factor IXa and factor X. Emicizumab-kxwh has an approximate molecular weight of 145.6 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Emicizumab-kxwh has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII. HEMLIBRA (emicizumab-kxwh) injection is a sterile, preservative-free, colorless to slightly yellow solution for subcutaneous injection supplied in single-dose vials containing emicizumab-kxwh at 12 mg/0.4 mL, 30 mg/mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/mL, or 300 mg/2 mL. Each single-dose 12 mg vial contains a 0.4 mL solution of emicizumab-kxwh (12 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 30 mg vial contains a 1 mL solution of emicizumab-kxwh (30 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 60 mg vial contains a 0.4 mL solution of emicizumab-kxwh (60 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 105 mg vial contains a 0.7 mL solution of emicizumab-kxwh (105 mg), L-arginine (18.3 mg), L-histidine (2.2 mg), and poloxamer 188 (0.4 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 150 mg vial contains a 1 mL solution of emicizumab-kxwh (150 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 300 mg vial contains a 2 mL solution of emicizumab-kxwh (300 mg), L-arginine (52.3 mg), L-histidine (6.2 mg), and poloxamer 188 (1 mg), adjusted to pH 6.0 with L-aspartic acid.</Description>
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<LabelerName>Genentech, Inc.</LabelerName>
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<StrengthUnit>mg/2mL</StrengthUnit>
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<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.</IndicationAndUsage>
<Description>Emicizumab-kxwh is a humanized monoclonal modified immunoglobulin G4 (IgG4) bispecific antibody binding factor IXa and factor X. Emicizumab-kxwh has an approximate molecular weight of 145.6 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Emicizumab-kxwh has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII. HEMLIBRA (emicizumab-kxwh) injection is a sterile, preservative-free, colorless to slightly yellow solution for subcutaneous injection supplied in single-dose vials containing emicizumab-kxwh at 12 mg/0.4 mL, 30 mg/mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/mL, or 300 mg/2 mL. Each single-dose 12 mg vial contains a 0.4 mL solution of emicizumab-kxwh (12 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 30 mg vial contains a 1 mL solution of emicizumab-kxwh (30 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 60 mg vial contains a 0.4 mL solution of emicizumab-kxwh (60 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 105 mg vial contains a 0.7 mL solution of emicizumab-kxwh (105 mg), L-arginine (18.3 mg), L-histidine (2.2 mg), and poloxamer 188 (0.4 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 150 mg vial contains a 1 mL solution of emicizumab-kxwh (150 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 300 mg vial contains a 2 mL solution of emicizumab-kxwh (300 mg), L-arginine (52.3 mg), L-histidine (6.2 mg), and poloxamer 188 (1 mg), adjusted to pH 6.0 with L-aspartic acid.</Description>
</NDC>
<NDC>
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<PackageDescription>120 L in 1 TANK (50242-931-01)</PackageDescription>
<NDC11Code>50242-0931-01</NDC11Code>
<ProductNDC>50242-931</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Somatropin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>19951229</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>SOMATROPIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/2L</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
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