{
"NDC": [
{
"NDCCode": "64764-805-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (64764-805-10) ",
"NDC11Code": "64764-0805-10",
"ProductNDC": "64764-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rozerem",
"NonProprietaryName": "Ramelteon",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050722",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021782",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "RAMELTEON",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050722",
"SamplePackage": "N",
"IndicationAndUsage": "ROZEREM® is indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)].",
"Description": "ROZEREM (ramelteon) is an orally active hypnotic chemically designated as (S)-N-[2-(1,6,7,8-tetrahydro-2H-indeno-[5,4-b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical formula of C16H21NO2, molecular weight of 259.34, and the following chemical structure. Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each ROZEREM tablet includes the following inactive ingredients: lactose monohydrate, starch, hydroxypropyl cellulose, magnesium stearate, hypromellose, copovidone, titanium dioxide, yellow ferric oxide, polyethylene glycol 8000, and ink containing shellac and synthetic iron oxide black."
},
{
"NDCCode": "64764-805-22",
"PackageDescription": "6 CARTON in 1 TRAY (64764-805-22) / 1 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64764-0805-22",
"ProductNDC": "64764-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rozerem",
"NonProprietaryName": "Ramelteon",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050722",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021782",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "RAMELTEON",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050722",
"SamplePackage": "N",
"IndicationAndUsage": "ROZEREM® is indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)].",
"Description": "ROZEREM (ramelteon) is an orally active hypnotic chemically designated as (S)-N-[2-(1,6,7,8-tetrahydro-2H-indeno-[5,4-b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical formula of C16H21NO2, molecular weight of 259.34, and the following chemical structure. Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each ROZEREM tablet includes the following inactive ingredients: lactose monohydrate, starch, hydroxypropyl cellulose, magnesium stearate, hypromellose, copovidone, titanium dioxide, yellow ferric oxide, polyethylene glycol 8000, and ink containing shellac and synthetic iron oxide black."
},
{
"NDCCode": "64764-805-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (64764-805-30) ",
"NDC11Code": "64764-0805-30",
"ProductNDC": "64764-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rozerem",
"NonProprietaryName": "Ramelteon",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050722",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021782",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "RAMELTEON",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050722",
"SamplePackage": "N",
"IndicationAndUsage": "ROZEREM® is indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)].",
"Description": "ROZEREM (ramelteon) is an orally active hypnotic chemically designated as (S)-N-[2-(1,6,7,8-tetrahydro-2H-indeno-[5,4-b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical formula of C16H21NO2, molecular weight of 259.34, and the following chemical structure. Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each ROZEREM tablet includes the following inactive ingredients: lactose monohydrate, starch, hydroxypropyl cellulose, magnesium stearate, hypromellose, copovidone, titanium dioxide, yellow ferric oxide, polyethylene glycol 8000, and ink containing shellac and synthetic iron oxide black."
},
{
"NDCCode": "13533-805-11",
"PackageDescription": "1 BAG in 1 CARTON (13533-805-11) / 100 mL in 1 BAG (13533-805-10) ",
"NDC11Code": "13533-0805-11",
"ProductNDC": "13533-805",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Gamunex-c",
"NonProprietaryName": "Immune Globulin (human)",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20101013",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125046",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101013",
"SamplePackage": "N",
"IndicationAndUsage": "GAMUNEX-C FlexBag is an immune globulin injection (human) 10% liquid that is indicated for the treatment of.",
"Description": "GAMUNEX-C FlexBag is a ready-to-use sterile, non-pyrogenic solution of human immune globulin protein for intravenous administration. GAMUNEX-C FlexBag is clear to opalescent, and colorless to pale yellow. GAMUNEX-C FlexBag consists of 9%–11% protein in 0.16–0.24 M glycine. Not less than 98% of the protein has the electrophoretic mobility of gamma globulin. The main component of GAMUNEX-C FlexBag is IgG (≥ 98%) with a sub-class distribution of IgG1, IgG2, IgG3 and IgG4 of approximately 62.8%, 29.7%, 4.8% and 2.7% respectively. The distribution of IgG subclasses is similar to that found in normal serum. GAMUNEX-C FlexBag contains trace levels of fragments, IgA (average 0.046 mg/mL), and IgM. GAMUNEX-C FlexBag doses of 1 g/kg correspond to a glycine dose of 0.15 g/kg. While toxic effects of glycine administration have been reported, the doses and rates of administration were 3–4 fold greater than those for GAMUNEX-C FlexBag. In another study it was demonstrated that intravenous bolus doses of 0.44 g/kg glycine were not associated with serious adverse effects. Caprylate is a saturated medium-chain (C8) fatty acid of plant origin. Medium chain fatty acids are considered to be essentially non-toxic. Human subjects receiving medium chain fatty acids parenterally have tolerated doses of 3.0 to 9.0 g/kg/day for periods of several months without adverse effects. Residual caprylate concentrations in the final container are no more than 0.216 g/L (1.3 mmol/L). The measured buffer capacity is 35 mEq/L (0.35 mEq/g protein) and the osmolality is approximately 258 mOsmol/kg solvent, which is close to physiological osmolality (285-295 mOsmol/kg). A dose of 1 g/kg body weight therefore represents an acid load of 0.35 mEq/kg body weight. The total buffering capacity of whole blood in a normal individual is 45–50 mEq/L of blood, or 3.6 mEq/kg body weight. Thus, the acid load delivered with a dose of 1 g/kg of GAMUNEX-C FlexBag would be neutralized by the buffering capacity of whole blood alone, even if the dose was infused instantaneously. The pH of GAMUNEX-C FlexBag is 4.0–4.5. GAMUNEX-C FlexBag contains no preservative. GAMUNEX-C FlexBag is not made with natural rubber latex. GAMUNEX-C FlexBag is made from large pools of human plasma by a combination of cold ethanol fractionation, caprylate precipitation and filtration, and anion-exchange chromatography. Isotonicity is achieved by the addition of glycine. GAMUNEX-C FlexBag is incubated in the final container (at the low pH of 4.0–4.3). The product is intended for intravenous administration. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model, using the following enveloped and non-enveloped viruses: human immunodeficiency virus, type I (HIV-1) as the relevant virus for HIV-1 and HIV–2; bovine viral diarrhea virus (BVDV) as a model for hepatitis C virus; pseudorabies virus (PRV) as a model for large enveloped DNA viruses (e.g., herpes viruses); Reovirus type 3 (Reo) as a model for non-enveloped viruses and for its resistance to physical and chemical inactivation; hepatitis A virus (HAV) as relevant non-enveloped virus, and porcine parvovirus (PPV) as a model for human parvovirus B19. Overall virus reduction was calculated only from steps that were mechanistically independent from each other and truly additive. In addition, each step was verified to provide robust virus reduction across the production range for key operating parameters. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. Several of the individual production steps in the GAMUNEX-C FlexBag manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include two depth filtrations (in sequence, a total of ≥ 6.6 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed."
},
{
"NDCCode": "16571-805-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (16571-805-10) ",
"NDC11Code": "16571-0805-10",
"ProductNDC": "16571-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyproheptadine Hydrochloride",
"NonProprietaryName": "Cyproheptadine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207555",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "CYPROHEPTADINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2022-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220210",
"SamplePackage": "N",
"IndicationAndUsage": "Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Cold urticaria. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.",
"Description": "Cyproheptadine HCl USP, is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride USP is a white to slightly yellowish crystalline solid, with a molecular weight of 350.89, which is soluble in water, freely soluble in methanol, sparingly soluble in ethanol, soluble in chloroform, and practically insoluble in ether. It is the sesquihydrate of 4-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C21H21NHCl and the structural formula of the anhydrous salt is. C21H21N HCl M.W. 350.89. Cyproheptadine hydrochloride USP is available for oral administration in 4 mg tablets. Inactive ingredients include: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "25010-805-08",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (25010-805-08) > 1 PELLET in 1 BLISTER PACK",
"NDC11Code": "25010-0805-08",
"ProductNDC": "25010-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacrisert",
"NonProprietaryName": "Hydroxypropyl Cellulose",
"DosageFormName": "PELLET",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19810601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018771",
"LabelerName": "Aton Pharma, Inc.",
"SubstanceName": "HYDROXYPROPYL CELLULOSE (TYPE H)",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Demulcent [EPC],Demulcent Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "31722-805-01",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (31722-805-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-805-31) ",
"NDC11Code": "31722-0805-01",
"ProductNDC": "31722-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204397",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2021-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210802",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.",
"Description": "Tolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is 2-[(1R)-3-[Bis (1-methylethyl) amino]-1-phenylpropyl] - 4- Methyl phenol tartrate. The empirical formula of tolterodine tartrate is C 22H 31NO.C 4H 6O 6, and its molecular weight is 475.57. The structural formula of tolterodine tartrate is represented below:. Tolterodine tartrate USP is a white or almost white crystalline powder. The pKa value is 9.87. Sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate USP. The inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, purified stearic acid, sodium starch glycolate and titanium dioxide. Additionally 1 mg tablet contains iron oxide yellow and iron oxide red."
},
{
"NDCCode": "31722-805-02",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (31722-805-02) > 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-805-32) ",
"NDC11Code": "31722-0805-02",
"ProductNDC": "31722-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204397",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2021-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210802",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.",
"Description": "Tolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is 2-[(1R)-3-[Bis (1-methylethyl) amino]-1-phenylpropyl] - 4- Methyl phenol tartrate. The empirical formula of tolterodine tartrate is C 22H 31NO.C 4H 6O 6, and its molecular weight is 475.57. The structural formula of tolterodine tartrate is represented below:. Tolterodine tartrate USP is a white or almost white crystalline powder. The pKa value is 9.87. Sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate USP. The inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, purified stearic acid, sodium starch glycolate and titanium dioxide. Additionally 1 mg tablet contains iron oxide yellow and iron oxide red."
},
{
"NDCCode": "35356-805-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (35356-805-10)",
"NDC11Code": "35356-0805-10",
"ProductNDC": "35356-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carisoprodol",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040755",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "CARISOPRODOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "43538-805-10",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (43538-805-10) / 10 mL in 1 VIAL, GLASS (43538-805-01) ",
"NDC11Code": "43538-0805-10",
"ProductNDC": "43538-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065401",
"LabelerName": "Eurofarma, Inc.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260620",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride for Injection is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection and other antibacterial drugs, Vancomycin Hydrochloride, for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
"Description": "Vancomycin Hydrochloride for Injection is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientals). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5- m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24∙ HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula."
},
{
"NDCCode": "51991-805-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (51991-805-10) ",
"NDC11Code": "51991-0805-10",
"ProductNDC": "51991-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180119",
"EndMarketingDate": "20201130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076033",
"LabelerName": "Breckenridge Pharmaceutical, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180119",
"EndMarketingDatePackage": "20200930",
"SamplePackage": "N"
},
{
"NDCCode": "54348-805-10",
"PackageDescription": "1 BOTTLE in 1 BOX (54348-805-10) > 10 TABLET in 1 BOTTLE",
"NDC11Code": "54348-0805-10",
"ProductNDC": "54348-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Medroxyprogesterone",
"NonProprietaryName": "Medroxyprogesterone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040159",
"LabelerName": "PharmPak, Inc.",
"SubstanceName": "MEDROXYPROGESTERONE ACETATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2022-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190712",
"SamplePackage": "N",
"IndicationAndUsage": "Medroxyprogesterone Acetate Tablets USP are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.",
"Description": "Medroxyprogesterone Acetate Tablets USP contain medroxyprogesterone acetate, USP which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is. Each tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate, USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, methylcellulose, pregelatinized corn starch, and sodium lauryl sulfate."
},
{
"NDCCode": "55390-805-10",
"PackageDescription": "10 VIAL in 1 BOX (55390-805-10) > 4 mL in 1 VIAL",
"NDC11Code": "55390-0805-10",
"ProductNDC": "55390-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daunorubicin Hydrochloride",
"NonProprietaryName": "Daunorubicin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19960628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064103",
"LabelerName": "Bedford Laboratories",
"SubstanceName": "DAUNORUBICIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-02-06"
},
{
"NDCCode": "59262-805-11",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (59262-805-11) / 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "59262-0805-11",
"ProductNDC": "59262-805",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Complete Eye Relief",
"ProprietaryNameSuffix": "Sterile Lubricant Eye Drops",
"NonProprietaryName": "Hydroxyethyl Cellulose",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20260101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Similasan Corporation",
"SubstanceName": "HYDROXYETHYLCELLULOSE",
"StrengthNumber": "3.5",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260101",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of burning and irritation due to dryness of the eye. For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind and sun. For use as a protectant against further irritation or to relieve dryness of the eye. For use as a lubricant to prevent further irritation or to relieve dryness of the eye."
},
{
"NDCCode": "59898-805-10",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (59898-805-10) ",
"NDC11Code": "59898-0805-10",
"ProductNDC": "59898-805",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Muscle",
"NonProprietaryName": "Menthol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100419",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "WATER-JEL TECHNOLOGIES",
"SubstanceName": "MENTHOL",
"StrengthNumber": "3.5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130317",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains."
},
{
"NDCCode": "60592-805-10",
"PackageDescription": "1000 g in 1 BOTTLE (60592-805-10)",
"NDC11Code": "60592-0805-10",
"ProductNDC": "60592-805",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Xylazine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20161024",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Kalchem International Inc.",
"SubstanceName": "XYLAZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "65841-805-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (65841-805-10) ",
"NDC11Code": "65841-0805-10",
"ProductNDC": "65841-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan",
"NonProprietaryName": "Telmisartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140827",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203325",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "TELMISARTAN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140827",
"SamplePackage": "N"
},
{
"NDCCode": "68094-805-10",
"PackageDescription": "112 TABLET in 1 BOTTLE, PLASTIC (68094-805-10) ",
"NDC11Code": "68094-0805-10",
"ProductNDC": "68094-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetrabenazine",
"NonProprietaryName": "Tetrabenazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207682",
"LabelerName": "Precision Dose Inc.",
"SubstanceName": "TETRABENAZINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231201",
"SamplePackage": "N",
"IndicationAndUsage": "Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington’s disease.",
"Description": "Tetrabenazine tablets are a monoamine depletor for oral administration. The molecular weight of tetrabenazine is 317.43; the pKa is 6.51. Tetrabenazine is a hexahydro-dimethoxy-benzoquinolizine derivative and has the following chemical name: cis rac –1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a] quinolizin-2-one. The empirical formula C19H27NO3 is represented by the following structural formula. Tetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol. Each tetrabenazine tablet contains either 12.5 or 25 mg of tetrabenazine as the active ingredient. Tetrabenazine tablets contain tetrabenazine as the active ingredient and the following inactive ingredients: lactose, magnesium stearate, maize starch, and talc. The 25 mg strength tablets also contain yellow iron oxide as an inactive ingredient. Tetrabenazine tablets are supplied as a yellowish-buff, scored tablet containing 25 mg of tetrabenazine or as a white, non-scored tablet containing 12.5 mg of tetrabenazine."
},
{
"NDCCode": "68382-805-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (68382-805-10) ",
"NDC11Code": "68382-0805-10",
"ProductNDC": "68382-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trazodone Hydrochloride",
"NonProprietaryName": "Trazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171211",
"EndMarketingDate": "20281231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205253",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "TRAZODONE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171211",
"EndMarketingDatePackage": "20281231",
"SamplePackage": "N",
"IndicationAndUsage": "Trazodone is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) (1).",
"Description": "Trazodone hydrochloride is a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride, USP is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]- 1,2,4-triazolo[4, 3-a]pyridin-3(2H)-one hydrochloride. It is a white to off-white, crystalline powder which is sparingly soluble in chloroform and in water. The structural formula is represented as follows. Molecular Formula: C19H22ClN5OHCl. Molecular Weight: 408.32. Each trazodone hydrochloride tablet, USP for oral administration contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate. The Product meets USP Dissolution Test #2."
},
{
"NDCCode": "68382-805-77",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68382-805-77) / 10 TABLET in 1 BLISTER PACK (68382-805-30) ",
"NDC11Code": "68382-0805-77",
"ProductNDC": "68382-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trazodone Hydrochloride",
"NonProprietaryName": "Trazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171211",
"EndMarketingDate": "20281231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205253",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "TRAZODONE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171211",
"EndMarketingDatePackage": "20281231",
"SamplePackage": "N",
"IndicationAndUsage": "Trazodone is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) (1).",
"Description": "Trazodone hydrochloride is a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride, USP is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]- 1,2,4-triazolo[4, 3-a]pyridin-3(2H)-one hydrochloride. It is a white to off-white, crystalline powder which is sparingly soluble in chloroform and in water. The structural formula is represented as follows. Molecular Formula: C19H22ClN5OHCl. Molecular Weight: 408.32. Each trazodone hydrochloride tablet, USP for oral administration contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate. The Product meets USP Dissolution Test #2."
},
{
"NDCCode": "70069-805-10",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (70069-805-10) > 10 mL in 1 VIAL, MULTI-DOSE (70069-805-01) ",
"NDC11Code": "70069-0805-10",
"ProductNDC": "70069-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neostigmine Methylsulfate",
"NonProprietaryName": "Neostigmine Methylsulfate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213074",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "NEOSTIGMINE METHYLSULFATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220110",
"SamplePackage": "N",
"IndicationAndUsage": "Neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.",
"Description": "Neostigmine methylsulfate, a cholinesterase inhibitor, is (m-hydroxyphenyl) trimethylammonium methylsulfate dimethylcarbamate. The structural formula is. Neostigmine methylsulfate is a white crystalline powder and is very soluble in water and soluble in alcohol. Neostigmine methylsulfate injection is a sterile, nonpyrogenic solution intended for intravenous use. Each mL of the 0.5 mg/mL strength contains neostigmine methylsulfate 0.5 mg, phenol 4.5 mg (used as preservative) and sodium acetate trihydrate 0.2 mg, in water for injection. The pH is adjusted, when necessary, with acetic acid/sodium hydroxide to achieve a value of 5.5. Each mL of the 1 mg/mL strength contains neostigmine methylsulfate 1 mg, phenol 4.5 mg (used as preservative), and sodium acetate trihydrate 0.2 mg, in water for injection. The pH is adjusted, when necessary, with acetic acid/sodium hydroxide to achieve a value of 5.5."
},
{
"NDCCode": "70954-805-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (70954-805-10) ",
"NDC11Code": "70954-0805-10",
"ProductNDC": "70954-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sovuna",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214581",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230915",
"SamplePackage": "N",
"IndicationAndUsage": "SOVUNA is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1), 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1), 3 Treatment of rheumatoid arthritis in adults. (1.2), 4 Treatment of systemic lupus erythematosus in adults. (1.3), 5 Treatment of chronic discoid lupus erythematosus in adults. (1.4).",
"Description": "SOVUNA contains hydroxychloroquine sulfate, an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4- quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate is a white or off-white crystalline powder, freely soluble in water; practically soluble in alcohol, chloroform, and ether. Each SOVUNA (hydroxychloroquine sulfate) Tablet, 200 mg for oral administration contains 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base. Each SOVUNA (hydroxychloroquine sulfate) Tablet, 300 mg for oral administration contains 300 mg hydroxychloroquine sulfate, equivalent to 232 mg base. Inactive Ingredients: Corn starch, croscarmellose sodium,hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sucralose, talc, titanium dioxide, triacetin and water. FDA approved dissolution test and acceptance criterion differ from USP."
},
{
"NDCCode": "71200-805-10",
"PackageDescription": "100 mL in 1 TUBE (71200-805-10)",
"NDC11Code": "71200-0805-10",
"ProductNDC": "71200-805",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunburn Soothing",
"NonProprietaryName": "Glycerin, Dimethicone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170102",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Supadelixir Co Ltd",
"SubstanceName": "GLYCERIN; DIMETHICONE",
"StrengthNumber": "60; 5",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-04-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "76420-805-10",
"PackageDescription": "10 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-805-10) ",
"NDC11Code": "76420-0805-10",
"ProductNDC": "76420-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202038",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240501",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets, USP a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C 16H 14F 2N 3NaO 4S x 1.5 H 2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.56 mg of pantoprazole sodium USP) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP). Pantoprazole sodium delayed-release tablets, USP contains the following inactive ingredients: calcium stearate, crospovidone, ferric oxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, sodium carbonate, and triethyl citrate. The tablets are imprinted with brown ink containing ammonium hydroxide, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac glaze in ethanol. Pantoprazole sodium delayed-release tablets (40 mg and 20 mg) complies USP dissolution test 3."
},
{
"NDCCode": "0944-2841-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2841-10) * 10 mL in 1 VIAL, GLASS (0944-2831-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) ",
"NDC11Code": "00944-2841-10",
"ProductNDC": "0944-2841",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Recombinate",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20090410",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103375",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090410",
"SamplePackage": "N",
"IndicationAndUsage": "The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.",
"Description": "RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate."
},
{
"NDCCode": "0944-2842-10",
"PackageDescription": "1 KIT in 1 CARTON (0944-2842-10) * 10 mL in 1 VIAL, GLASS (0944-2832-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) ",
"NDC11Code": "00944-2842-10",
"ProductNDC": "0944-2842",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Recombinate",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20090410",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103375",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090410",
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"IndicationAndUsage": "The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.",
"Description": "RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate."
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"Description": "RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate."
},
{
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"IndicationAndUsage": "The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.",
"Description": "RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate."
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{
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"IndicationAndUsage": "The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.",
"Description": "RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate."
},
{
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"ProductNDC": "0944-3045",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Advate",
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"ApplicationNumber": "BLA125063",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
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"IndicationAndUsage": "ADVATE® [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: 1 Control and prevention of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.",
"Description": "ADVATE [Antihemophilic Factor (Recombinant)] is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line but does not contain plasma or albumin. The CHO cell line employed in the production of ADVATE is derived from that used in the biosynthesis of RECOMBINATE® [Antihemophilic Factor (Recombinant)]. ADVATE has been shown to be comparable to RECOMBINATE with respect to its biochemical and physicochemical properties, as well as its nonclinical in vivo pharmacology. In culture, the CHO cell line expresses the recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the rAHF from the medium. The cell culture and purification processes used in the manufacture of ADVATE employ no additives of human or animal origin. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The rAHF synthesized by the CHO cells has the same biological effects on clotting as human antihemophilic factor (hAHF). Structurally, the recombinant protein has a similar combination of heterogeneous heavy and light chains as found in AHF (Human). ADVATE is formulated as a sterile, nonpyrogenic, white to off-white powder for intravenous injection. ADVATE in a single-dose vial contains nominally 250, 500, 1000, 1500, 2000, 3000, or 4000 International Units (IU). The product contains the following stabilizers and excipients: mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and glutathione. Von Willebrand factor (VWF) is co-expressed with factor VIII and helps to stabilize it in culture. The final product contains no more than 2 ng VWF/IU rAHF, which will not have any clinically relevant effect in patients with von Willebrand disease. The product contains no preservative. When reconstituted with the provided Sterile Water for Injection, USP, the final solution contains the following stabilizers and excipients in targeted amounts:. Each ADVATE housing is labeled with the rAHF activity expressed in international units. Biological potency is determined by an in vitro assay, which employs a factor VIII concentrate standard that is referenced to a WHO international standard for factor VIII concentrates. One international unit, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. The specific activity of ADVATE is 4000 to 10000 International Units per milligram of protein."
}
]
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GAMUNEX-C FlexBag is an immune globulin injection (human) 10% liquid that is indicated for the treatment of.</IndicationAndUsage>
<Description>GAMUNEX-C FlexBag is a ready-to-use sterile, non-pyrogenic solution of human immune globulin protein for intravenous administration. GAMUNEX-C FlexBag is clear to opalescent, and colorless to pale yellow. GAMUNEX-C FlexBag consists of 9%–11% protein in 0.16–0.24 M glycine. Not less than 98% of the protein has the electrophoretic mobility of gamma globulin. The main component of GAMUNEX-C FlexBag is IgG (≥ 98%) with a sub-class distribution of IgG1, IgG2, IgG3 and IgG4 of approximately 62.8%, 29.7%, 4.8% and 2.7% respectively. The distribution of IgG subclasses is similar to that found in normal serum. GAMUNEX-C FlexBag contains trace levels of fragments, IgA (average 0.046 mg/mL), and IgM. GAMUNEX-C FlexBag doses of 1 g/kg correspond to a glycine dose of 0.15 g/kg. While toxic effects of glycine administration have been reported, the doses and rates of administration were 3–4 fold greater than those for GAMUNEX-C FlexBag. In another study it was demonstrated that intravenous bolus doses of 0.44 g/kg glycine were not associated with serious adverse effects. Caprylate is a saturated medium-chain (C8) fatty acid of plant origin. Medium chain fatty acids are considered to be essentially non-toxic. Human subjects receiving medium chain fatty acids parenterally have tolerated doses of 3.0 to 9.0 g/kg/day for periods of several months without adverse effects. Residual caprylate concentrations in the final container are no more than 0.216 g/L (1.3 mmol/L). The measured buffer capacity is 35 mEq/L (0.35 mEq/g protein) and the osmolality is approximately 258 mOsmol/kg solvent, which is close to physiological osmolality (285-295 mOsmol/kg). A dose of 1 g/kg body weight therefore represents an acid load of 0.35 mEq/kg body weight. The total buffering capacity of whole blood in a normal individual is 45–50 mEq/L of blood, or 3.6 mEq/kg body weight. Thus, the acid load delivered with a dose of 1 g/kg of GAMUNEX-C FlexBag would be neutralized by the buffering capacity of whole blood alone, even if the dose was infused instantaneously. The pH of GAMUNEX-C FlexBag is 4.0–4.5. GAMUNEX-C FlexBag contains no preservative. GAMUNEX-C FlexBag is not made with natural rubber latex. GAMUNEX-C FlexBag is made from large pools of human plasma by a combination of cold ethanol fractionation, caprylate precipitation and filtration, and anion-exchange chromatography. Isotonicity is achieved by the addition of glycine. GAMUNEX-C FlexBag is incubated in the final container (at the low pH of 4.0–4.3). The product is intended for intravenous administration. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model, using the following enveloped and non-enveloped viruses: human immunodeficiency virus, type I (HIV-1) as the relevant virus for HIV-1 and HIV–2; bovine viral diarrhea virus (BVDV) as a model for hepatitis C virus; pseudorabies virus (PRV) as a model for large enveloped DNA viruses (e.g., herpes viruses); Reovirus type 3 (Reo) as a model for non-enveloped viruses and for its resistance to physical and chemical inactivation; hepatitis A virus (HAV) as relevant non-enveloped virus, and porcine parvovirus (PPV) as a model for human parvovirus B19. Overall virus reduction was calculated only from steps that were mechanistically independent from each other and truly additive. In addition, each step was verified to provide robust virus reduction across the production range for key operating parameters. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. Several of the individual production steps in the GAMUNEX-C FlexBag manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include two depth filtrations (in sequence, a total of ≥ 6.6 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
</NDC>
<NDC>
<NDCCode>16571-805-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (16571-805-10) </PackageDescription>
<NDC11Code>16571-0805-10</NDC11Code>
<ProductNDC>16571-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyproheptadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyproheptadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207555</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CYPROHEPTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Cold urticaria. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.</IndicationAndUsage>
<Description>Cyproheptadine HCl USP, is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride USP is a white to slightly yellowish crystalline solid, with a molecular weight of 350.89, which is soluble in water, freely soluble in methanol, sparingly soluble in ethanol, soluble in chloroform, and practically insoluble in ether. It is the sesquihydrate of 4-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C21H21NHCl and the structural formula of the anhydrous salt is. C21H21N HCl M.W. 350.89. Cyproheptadine hydrochloride USP is available for oral administration in 4 mg tablets. Inactive ingredients include: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>25010-805-08</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (25010-805-08) > 1 PELLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>25010-0805-08</NDC11Code>
<ProductNDC>25010-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacrisert</ProprietaryName>
<NonProprietaryName>Hydroxypropyl Cellulose</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19810601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018771</ApplicationNumber>
<LabelerName>Aton Pharma, Inc.</LabelerName>
<SubstanceName>HYDROXYPROPYL CELLULOSE (TYPE H)</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Demulcent [EPC],Demulcent Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>31722-805-01</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (31722-805-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-805-31) </PackageDescription>
<NDC11Code>31722-0805-01</NDC11Code>
<ProductNDC>31722-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolterodine Tartrate</ProprietaryName>
<NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210802</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204397</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.</IndicationAndUsage>
<Description>Tolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is 2-[(1R)-3-[Bis (1-methylethyl) amino]-1-phenylpropyl] - 4- Methyl phenol tartrate. The empirical formula of tolterodine tartrate is C 22H 31NO.C 4H 6O 6, and its molecular weight is 475.57. The structural formula of tolterodine tartrate is represented below:. Tolterodine tartrate USP is a white or almost white crystalline powder. The pKa value is 9.87. Sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate USP. The inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, purified stearic acid, sodium starch glycolate and titanium dioxide. Additionally 1 mg tablet contains iron oxide yellow and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>31722-805-02</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (31722-805-02) > 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-805-32) </PackageDescription>
<NDC11Code>31722-0805-02</NDC11Code>
<ProductNDC>31722-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolterodine Tartrate</ProprietaryName>
<NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210802</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204397</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.</IndicationAndUsage>
<Description>Tolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is 2-[(1R)-3-[Bis (1-methylethyl) amino]-1-phenylpropyl] - 4- Methyl phenol tartrate. The empirical formula of tolterodine tartrate is C 22H 31NO.C 4H 6O 6, and its molecular weight is 475.57. The structural formula of tolterodine tartrate is represented below:. Tolterodine tartrate USP is a white or almost white crystalline powder. The pKa value is 9.87. Sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate USP. The inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, purified stearic acid, sodium starch glycolate and titanium dioxide. Additionally 1 mg tablet contains iron oxide yellow and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>35356-805-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (35356-805-10)</PackageDescription>
<NDC11Code>35356-0805-10</NDC11Code>
<ProductNDC>35356-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carisoprodol</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040755</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43538-805-10</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (43538-805-10) / 10 mL in 1 VIAL, GLASS (43538-805-01) </PackageDescription>
<NDC11Code>43538-0805-10</NDC11Code>
<ProductNDC>43538-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065401</ApplicationNumber>
<LabelerName>Eurofarma, Inc.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride for Injection is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection and other antibacterial drugs, Vancomycin Hydrochloride, for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientals). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5- m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24∙ HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>51991-805-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (51991-805-10) </PackageDescription>
<NDC11Code>51991-0805-10</NDC11Code>
<ProductNDC>51991-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180119</StartMarketingDate>
<EndMarketingDate>20201130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076033</ApplicationNumber>
<LabelerName>Breckenridge Pharmaceutical, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180119</StartMarketingDatePackage>
<EndMarketingDatePackage>20200930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54348-805-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (54348-805-10) > 10 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>54348-0805-10</NDC11Code>
<ProductNDC>54348-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Medroxyprogesterone</ProprietaryName>
<NonProprietaryName>Medroxyprogesterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040159</ApplicationNumber>
<LabelerName>PharmPak, Inc.</LabelerName>
<SubstanceName>MEDROXYPROGESTERONE ACETATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Medroxyprogesterone Acetate Tablets USP are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.</IndicationAndUsage>
<Description>Medroxyprogesterone Acetate Tablets USP contain medroxyprogesterone acetate, USP which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is. Each tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate, USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, methylcellulose, pregelatinized corn starch, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>55390-805-10</NDCCode>
<PackageDescription>10 VIAL in 1 BOX (55390-805-10) > 4 mL in 1 VIAL</PackageDescription>
<NDC11Code>55390-0805-10</NDC11Code>
<ProductNDC>55390-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Daunorubicin Hydrochloride</ProprietaryName>
<NonProprietaryName>Daunorubicin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19960628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064103</ApplicationNumber>
<LabelerName>Bedford Laboratories</LabelerName>
<SubstanceName>DAUNORUBICIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-02-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>59262-805-11</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (59262-805-11) / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>59262-0805-11</NDC11Code>
<ProductNDC>59262-805</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Complete Eye Relief</ProprietaryName>
<ProprietaryNameSuffix>Sterile Lubricant Eye Drops</ProprietaryNameSuffix>
<NonProprietaryName>Hydroxyethyl Cellulose</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20260101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Similasan Corporation</LabelerName>
<SubstanceName>HYDROXYETHYLCELLULOSE</SubstanceName>
<StrengthNumber>3.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of burning and irritation due to dryness of the eye. For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind and sun. For use as a protectant against further irritation or to relieve dryness of the eye. For use as a lubricant to prevent further irritation or to relieve dryness of the eye.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59898-805-10</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (59898-805-10) </PackageDescription>
<NDC11Code>59898-0805-10</NDC11Code>
<ProductNDC>59898-805</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Muscle</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100419</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>WATER-JEL TECHNOLOGIES</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>3.5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60592-805-10</NDCCode>
<PackageDescription>1000 g in 1 BOTTLE (60592-805-10)</PackageDescription>
<NDC11Code>60592-0805-10</NDC11Code>
<ProductNDC>60592-805</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Xylazine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20161024</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Kalchem International Inc.</LabelerName>
<SubstanceName>XYLAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65841-805-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (65841-805-10) </PackageDescription>
<NDC11Code>65841-0805-10</NDC11Code>
<ProductNDC>65841-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan</ProprietaryName>
<NonProprietaryName>Telmisartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140827</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203325</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>TELMISARTAN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68094-805-10</NDCCode>
<PackageDescription>112 TABLET in 1 BOTTLE, PLASTIC (68094-805-10) </PackageDescription>
<NDC11Code>68094-0805-10</NDC11Code>
<ProductNDC>68094-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetrabenazine</ProprietaryName>
<NonProprietaryName>Tetrabenazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207682</ApplicationNumber>
<LabelerName>Precision Dose Inc.</LabelerName>
<SubstanceName>TETRABENAZINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington’s disease.</IndicationAndUsage>
<Description>Tetrabenazine tablets are a monoamine depletor for oral administration. The molecular weight of tetrabenazine is 317.43; the pKa is 6.51. Tetrabenazine is a hexahydro-dimethoxy-benzoquinolizine derivative and has the following chemical name: cis rac –1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a] quinolizin-2-one. The empirical formula C19H27NO3 is represented by the following structural formula. Tetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol. Each tetrabenazine tablet contains either 12.5 or 25 mg of tetrabenazine as the active ingredient. Tetrabenazine tablets contain tetrabenazine as the active ingredient and the following inactive ingredients: lactose, magnesium stearate, maize starch, and talc. The 25 mg strength tablets also contain yellow iron oxide as an inactive ingredient. Tetrabenazine tablets are supplied as a yellowish-buff, scored tablet containing 25 mg of tetrabenazine or as a white, non-scored tablet containing 12.5 mg of tetrabenazine.</Description>
</NDC>
<NDC>
<NDCCode>68382-805-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (68382-805-10) </PackageDescription>
<NDC11Code>68382-0805-10</NDC11Code>
<ProductNDC>68382-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171211</StartMarketingDate>
<EndMarketingDate>20281231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205253</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171211</StartMarketingDatePackage>
<EndMarketingDatePackage>20281231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trazodone is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) (1).</IndicationAndUsage>
<Description>Trazodone hydrochloride is a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride, USP is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]- 1,2,4-triazolo[4, 3-a]pyridin-3(2H)-one hydrochloride. It is a white to off-white, crystalline powder which is sparingly soluble in chloroform and in water. The structural formula is represented as follows. Molecular Formula: C19H22ClN5OHCl. Molecular Weight: 408.32. Each trazodone hydrochloride tablet, USP for oral administration contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate. The Product meets USP Dissolution Test #2.</Description>
</NDC>
<NDC>
<NDCCode>68382-805-77</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68382-805-77) / 10 TABLET in 1 BLISTER PACK (68382-805-30) </PackageDescription>
<NDC11Code>68382-0805-77</NDC11Code>
<ProductNDC>68382-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171211</StartMarketingDate>
<EndMarketingDate>20281231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205253</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171211</StartMarketingDatePackage>
<EndMarketingDatePackage>20281231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trazodone is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) (1).</IndicationAndUsage>
<Description>Trazodone hydrochloride is a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride, USP is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]- 1,2,4-triazolo[4, 3-a]pyridin-3(2H)-one hydrochloride. It is a white to off-white, crystalline powder which is sparingly soluble in chloroform and in water. The structural formula is represented as follows. Molecular Formula: C19H22ClN5OHCl. Molecular Weight: 408.32. Each trazodone hydrochloride tablet, USP for oral administration contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate. The Product meets USP Dissolution Test #2.</Description>
</NDC>
<NDC>
<NDCCode>70069-805-10</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (70069-805-10) > 10 mL in 1 VIAL, MULTI-DOSE (70069-805-01) </PackageDescription>
<NDC11Code>70069-0805-10</NDC11Code>
<ProductNDC>70069-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neostigmine Methylsulfate</ProprietaryName>
<NonProprietaryName>Neostigmine Methylsulfate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213074</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>NEOSTIGMINE METHYLSULFATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.</IndicationAndUsage>
<Description>Neostigmine methylsulfate, a cholinesterase inhibitor, is (m-hydroxyphenyl) trimethylammonium methylsulfate dimethylcarbamate. The structural formula is. Neostigmine methylsulfate is a white crystalline powder and is very soluble in water and soluble in alcohol. Neostigmine methylsulfate injection is a sterile, nonpyrogenic solution intended for intravenous use. Each mL of the 0.5 mg/mL strength contains neostigmine methylsulfate 0.5 mg, phenol 4.5 mg (used as preservative) and sodium acetate trihydrate 0.2 mg, in water for injection. The pH is adjusted, when necessary, with acetic acid/sodium hydroxide to achieve a value of 5.5. Each mL of the 1 mg/mL strength contains neostigmine methylsulfate 1 mg, phenol 4.5 mg (used as preservative), and sodium acetate trihydrate 0.2 mg, in water for injection. The pH is adjusted, when necessary, with acetic acid/sodium hydroxide to achieve a value of 5.5.</Description>
</NDC>
<NDC>
<NDCCode>70954-805-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (70954-805-10) </PackageDescription>
<NDC11Code>70954-0805-10</NDC11Code>
<ProductNDC>70954-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sovuna</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214581</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOVUNA is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1), 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1), 3 Treatment of rheumatoid arthritis in adults. (1.2), 4 Treatment of systemic lupus erythematosus in adults. (1.3), 5 Treatment of chronic discoid lupus erythematosus in adults. (1.4).</IndicationAndUsage>
<Description>SOVUNA contains hydroxychloroquine sulfate, an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4- quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate is a white or off-white crystalline powder, freely soluble in water; practically soluble in alcohol, chloroform, and ether. Each SOVUNA (hydroxychloroquine sulfate) Tablet, 200 mg for oral administration contains 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base. Each SOVUNA (hydroxychloroquine sulfate) Tablet, 300 mg for oral administration contains 300 mg hydroxychloroquine sulfate, equivalent to 232 mg base. Inactive Ingredients: Corn starch, croscarmellose sodium,hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sucralose, talc, titanium dioxide, triacetin and water. FDA approved dissolution test and acceptance criterion differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>71200-805-10</NDCCode>
<PackageDescription>100 mL in 1 TUBE (71200-805-10)</PackageDescription>
<NDC11Code>71200-0805-10</NDC11Code>
<ProductNDC>71200-805</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunburn Soothing</ProprietaryName>
<NonProprietaryName>Glycerin, Dimethicone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Supadelixir Co Ltd</LabelerName>
<SubstanceName>GLYCERIN; DIMETHICONE</SubstanceName>
<StrengthNumber>60; 5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-04-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>76420-805-10</NDCCode>
<PackageDescription>10 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-805-10) </PackageDescription>
<NDC11Code>76420-0805-10</NDC11Code>
<ProductNDC>76420-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202038</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets, USP a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C 16H 14F 2N 3NaO 4S x 1.5 H 2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.56 mg of pantoprazole sodium USP) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP). Pantoprazole sodium delayed-release tablets, USP contains the following inactive ingredients: calcium stearate, crospovidone, ferric oxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, sodium carbonate, and triethyl citrate. The tablets are imprinted with brown ink containing ammonium hydroxide, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac glaze in ethanol. Pantoprazole sodium delayed-release tablets (40 mg and 20 mg) complies USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>0944-2841-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2841-10) * 10 mL in 1 VIAL, GLASS (0944-2831-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
<NDC11Code>00944-2841-10</NDC11Code>
<ProductNDC>0944-2841</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Recombinate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20090410</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.</Description>
</NDC>
<NDC>
<NDCCode>0944-2842-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2842-10) * 10 mL in 1 VIAL, GLASS (0944-2832-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
<NDC11Code>00944-2842-10</NDC11Code>
<ProductNDC>0944-2842</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Recombinate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20090410</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.</Description>
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<IndicationAndUsage>The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.</Description>
</NDC>
<NDC>
<NDCCode>0944-2845-10</NDCCode>
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<ApplicationNumber>BLA103375</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand's disease.</IndicationAndUsage>
<Description>RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII. RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.</Description>
</NDC>
<NDC>
<NDCCode>0944-3045-10</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CONTAINER (0944-3045-10) / 1 CONTAINER in 1 BLISTER PACK (0944-3045-12) / 1 KIT in 1 CONTAINER (0944-3045-11) * 5 mL in 1 VIAL, GLASS (0944-2945-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
<NDC11Code>00944-3045-10</NDC11Code>
<ProductNDC>0944-3045</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Advate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20060412</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125063</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADVATE® [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: 1 Control and prevention of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ADVATE [Antihemophilic Factor (Recombinant)] is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line but does not contain plasma or albumin. The CHO cell line employed in the production of ADVATE is derived from that used in the biosynthesis of RECOMBINATE® [Antihemophilic Factor (Recombinant)]. ADVATE has been shown to be comparable to RECOMBINATE with respect to its biochemical and physicochemical properties, as well as its nonclinical in vivo pharmacology. In culture, the CHO cell line expresses the recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the rAHF from the medium. The cell culture and purification processes used in the manufacture of ADVATE employ no additives of human or animal origin. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The rAHF synthesized by the CHO cells has the same biological effects on clotting as human antihemophilic factor (hAHF). Structurally, the recombinant protein has a similar combination of heterogeneous heavy and light chains as found in AHF (Human). ADVATE is formulated as a sterile, nonpyrogenic, white to off-white powder for intravenous injection. ADVATE in a single-dose vial contains nominally 250, 500, 1000, 1500, 2000, 3000, or 4000 International Units (IU). The product contains the following stabilizers and excipients: mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and glutathione. Von Willebrand factor (VWF) is co-expressed with factor VIII and helps to stabilize it in culture. The final product contains no more than 2 ng VWF/IU rAHF, which will not have any clinically relevant effect in patients with von Willebrand disease. The product contains no preservative. When reconstituted with the provided Sterile Water for Injection, USP, the final solution contains the following stabilizers and excipients in targeted amounts:. Each ADVATE housing is labeled with the rAHF activity expressed in international units. Biological potency is determined by an in vitro assay, which employs a factor VIII concentrate standard that is referenced to a WHO international standard for factor VIII concentrates. One international unit, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. The specific activity of ADVATE is 4000 to 10000 International Units per milligram of protein.</Description>
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