RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>76125-256-20</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (76125-256-20)  *  5 mL in 1 VIAL, GLASS (76125-252-21)  *  5 mL in 1 VIAL, GLASS (13533-000-04) </PackageDescription>
    <NDC11Code>76125-0256-20</NDC11Code>
    <ProductNDC>76125-256</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Koate</ProprietaryName>
    <NonProprietaryName>Antihemophilic Factor (human)</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19990520</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101130</ApplicationNumber>
    <LabelerName>KEDRION BIOPHARMA, INC.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2023-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19990520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KOĀTE® is a human plasma-derived antihemophilic factor indicated for the control and prevention of bleeding episodes or in order to perform emergency and elective surgery in patients with hemophilia A (hereditary Factor VIII deficiency). Limitation of Use. KOĀTE is not indicated for the treatment of von Willebrand disease.</IndicationAndUsage>
    <Description>KOĀTE, Antihemophilic Factor (Human), is a sterile, stable, dried concentrate of human antihemophilic factor  in lyophilized powder form for reconstitution for intravenous injection.  The product is supplied in single-use vials containing nominally 250, 500, or 1,000 international units (IU or units). Each vial of KOĀTE is labeled with the actual amount of Factor VIII expressed in IU. One IU is defined by the current World Health Organization International Standard for Factor VIII concentrate, which can be traced to the level of Factor VIII found in 1 mL of fresh pooled human plasma. The final product when reconstituted as directed contains not more than (NMT) 1500 μg/mL polyethylene glycol (PEG), NMT 0.05 M glycine, NMT 25 μg/mL polysorbate 80, NMT 5 μg/g tri-n-butyl phosphate (TNBP), NMT 3 mM calcium, NMT 1 μg/mL aluminum, NMT 0.06 M histidine, and NMT 10 mg/mL human albumin. KOĀTE is purified from the cold insoluble fraction of pooled human plasma; the manufacturing process includes solvent/detergent (TNBP and polysorbate 80) treatment and heat treatment of the lyophilized final container. A gel permeation chromatography step serves the dual purpose of reducing the amount of TNBP and polysorbate 80 as well as increasing the purity of the Factor VIII in KOĀTE to 300 to 1,000 times over whole plasma. When reconstituted as directed, KOĀTE contains approximately 50 to 150 times as much Factor VIII as an equal volume of fresh plasma. The specific activity after addition of human albumin is in the range of 9 to 22 units/mg protein. KOĀTE also contains naturally occurring von Willebrand factor, which is co-purified as part of the manufacturing process. The KOĀTE manufacturing process includes two dedicated steps with virus inactivation capacity. The solvent/detergent treatment step has the capacity to inactivate enveloped viruses (such as HIV, HCV, HBV, and WNV). Heat treatment at 80ºC for 72 hours has the capacity to inactivate enveloped viruses (such as HIV and HCV) as well as non‑enveloped viruses (such as HAV and B19V). The polyethylene glycol (PEG) precipitation/depth filtration step has the capacity to remove both enveloped and non‑enveloped viruses. The accumulated virus reduction factors for KOĀTE manufacturing process are presented in Table 2. Additionally, the KOĀTE manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. The manufacturing process has been shown to decrease TSE infectivity of that experimental model agent (a total of 5.1 log10 reduction), providing reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>76125-250-20</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (76125-250-20)  *  5 mL in 1 VIAL, GLASS (76125-252-21)  *  5 mL in 1 VIAL, GLASS (13533-000-04) </PackageDescription>
    <NDC11Code>76125-0250-20</NDC11Code>
    <ProductNDC>76125-250</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Koate</ProprietaryName>
    <NonProprietaryName>Antihemophilic Factor (human)</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19990520</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101130</ApplicationNumber>
    <LabelerName>KEDRION BIOPHARMA, INC.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2023-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19990520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KOĀTE® is a human plasma-derived antihemophilic factor indicated for the control and prevention of bleeding episodes or in order to perform emergency and elective surgery in patients with hemophilia A (hereditary Factor VIII deficiency). Limitation of Use. KOĀTE is not indicated for the treatment of von Willebrand disease.</IndicationAndUsage>
    <Description>KOĀTE, Antihemophilic Factor (Human), is a sterile, stable, dried concentrate of human antihemophilic factor  in lyophilized powder form for reconstitution for intravenous injection.  The product is supplied in single-use vials containing nominally 250, 500, or 1,000 international units (IU or units). Each vial of KOĀTE is labeled with the actual amount of Factor VIII expressed in IU. One IU is defined by the current World Health Organization International Standard for Factor VIII concentrate, which can be traced to the level of Factor VIII found in 1 mL of fresh pooled human plasma. The final product when reconstituted as directed contains not more than (NMT) 1500 μg/mL polyethylene glycol (PEG), NMT 0.05 M glycine, NMT 25 μg/mL polysorbate 80, NMT 5 μg/g tri-n-butyl phosphate (TNBP), NMT 3 mM calcium, NMT 1 μg/mL aluminum, NMT 0.06 M histidine, and NMT 10 mg/mL human albumin. KOĀTE is purified from the cold insoluble fraction of pooled human plasma; the manufacturing process includes solvent/detergent (TNBP and polysorbate 80) treatment and heat treatment of the lyophilized final container. A gel permeation chromatography step serves the dual purpose of reducing the amount of TNBP and polysorbate 80 as well as increasing the purity of the Factor VIII in KOĀTE to 300 to 1,000 times over whole plasma. When reconstituted as directed, KOĀTE contains approximately 50 to 150 times as much Factor VIII as an equal volume of fresh plasma. The specific activity after addition of human albumin is in the range of 9 to 22 units/mg protein. KOĀTE also contains naturally occurring von Willebrand factor, which is co-purified as part of the manufacturing process. The KOĀTE manufacturing process includes two dedicated steps with virus inactivation capacity. The solvent/detergent treatment step has the capacity to inactivate enveloped viruses (such as HIV, HCV, HBV, and WNV). Heat treatment at 80ºC for 72 hours has the capacity to inactivate enveloped viruses (such as HIV and HCV) as well as non‑enveloped viruses (such as HAV and B19V). The polyethylene glycol (PEG) precipitation/depth filtration step has the capacity to remove both enveloped and non‑enveloped viruses. The accumulated virus reduction factors for KOĀTE manufacturing process are presented in Table 2. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. The manufacturing process has been shown to decrease TSE infectivity of that experimental model agent (a total of 5.1 log10 reduction), providing reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>76125-784-20</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (76125-784-20)  &gt; 20 mL in 1 VIAL (76125-784-21) </PackageDescription>
    <NDC11Code>76125-0784-20</NDC11Code>
    <ProductNDC>76125-784</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Albuked</ProprietaryName>
    <NonProprietaryName>Albumin (human)</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19421021</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101138</ApplicationNumber>
    <LabelerName>KEDRION BIOPHARMA, INC.</LabelerName>
    <SubstanceName>ALBUMIN HUMAN</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19421021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>76125-792-20</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (76125-792-20)  &gt; 20 mL in 1 VIAL (76125-792-21) </PackageDescription>
    <NDC11Code>76125-0792-20</NDC11Code>
    <ProductNDC>76125-792</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Albuked</ProprietaryName>
    <NonProprietaryName>Albumin (human)</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19421021</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101138</ApplicationNumber>
    <LabelerName>KEDRION BIOPHARMA, INC.</LabelerName>
    <SubstanceName>ALBUMIN HUMAN</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19421021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Emergency Treatment of Hypovolemic Shock. Albuked 25 is hyperoncotic and on intravenous infusion will expand the plasma volume by an additional amount, three to four times the volume actually administered, by withdrawing fluid from the interstitial spaces, provided the patient is normally hydrated interstitially or there is interstitial edema.(1) If the patient is dehydrated, additional crystalloids must be given,(4) or alternatively, Albumin (Human) 5%, USP (Albuked 5) should be used. The patient’s hemodynamic response should be monitored and the usual precautions against circulatory overload observed. The total dose should not exceed the level of albumin found in the normal individual, i.e., about 2 g per kg body weight in the absence of active bleeding. Although Albuked 5 is to be preferred for the usual volume deficits, Albuked 25 with appropriate crystalloids may offer therapeutic advantages in oncotic deficits or in long-standing shock where treatment has been delayed.(2). Removal of ascitic fluid from a patient with cirrhosis may cause changes in cardiovascular function and even result in hypovolemic shock. In such circumstances, the use of an albumin infusion may be required to support the blood volume.(2). Burn Therapy. An optimal therapeutic regimen with respect to the administration of colloids, crystalloids, and water following extensive burns has not been established. During the first 24 hours after sustaining thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours Albuked 25 can be used to maintain plasma colloid osmotic pressure. Hypoproteinemia With or Without Edema. During major surgery, patients can lose over half of their circulating albumin with the attendant complications of oncotic deficit.(2,4,5) A similar situation can occur in sepsis or intensive care patients. Treatment with Albuked 25 may be of value in such cases.(2). Adult Respiratory Distress Syndrome (ARDS)(2,5). This is characterized by deficient oxygenation caused by pulmonary interstitial edema complicating shock and postsurgical conditions. When clinical signs are those of hypoproteinemia with a fluid volume overload, Albuked 25 together with a diuretic may play a role in therapy. Cardiopulmonary Bypass(2,6). With the relatively small priming volume required with modern pumps, preoperative dilution of the blood using albumin and crystalloid has been shown to be safe and well-tolerated. Although the limit to which the hematocrit and plasma protein concentration can be safely lowered has not been defined, it is common practice to adjust the albumin and crystalloid pump prime to achieve a hematocrit of 20% and a plasma albumin concentration of 2.5 g per 100 mL in the patient. Acute Liver Failure (2). In the uncommon situation of rapid loss of liver function with or without coma, administration of albumin may serve the double purpose of supporting the colloid osmotic pressure of the plasma as well as binding excess plasma bilirubin. Neonatal Hemolytic Disease(2,3). The administration of Albuked 25 may be indicated prior to exchange transfusion, in order to bind free bilirubin, thus lessening the risk of kernicterus. A dosage of 1 g /kg body weight is given about 1 hour prior to exchange transfusion. Caution must be observed in hypervolemic infants. Sequestration of Protein Rich Fluids(7). This occurs in such conditions as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis. The magnitude of loss into the third space may require treatment of reduced volume or oncotic activity with an infusion of albumin. Erythrocyte Resuspension(2). Albumin may be required to avoid excessive hypoproteinemia, during certain types of exchange transfusion, or with the use of very large volumes of previously frozen or washed red cells. About 25 g of albumin per liter of erythrocytes is commonly used, although the requirements in preexistent hypoproteinemia or hepatic impairment can be greater. Albuked 25 is added to the isotonic suspension of washed red cells immediately prior to transfusion. Acute Nephrosis(2). Certain patients may not respond to cyclophosphamide or steroid therapy. The steroids may even aggravate the underlying edema. In this situation a loop diuretic and 100 mL Albuked 25 repeated daily for 7 to 10 days may be helpful in controlling the edema and the patient may then respond to steroid treatment. Renal Dialysis(2). Although not part of the regular regimen of renal dialysis, Albuked 25 may be of value in the treatment of shock or hypotension in these patients. The usual volume administered is about 100 mL, taking particular care to avoid fluid overload as these patients are often fluid overloaded and cannot tolerate substantial volumes of salt solution. Situations in Which Albumin Administration is Not Warranted(2). In chronic nephrosis, infused albumin is promptly excreted by the kidneys with no relief of the chronic edema or effect on the underlying renal lesion. It is of occasional use in the rapid “priming” diuresis of nephrosis. Similarly, in hypoproteinemic states associated with chronic cirrhosis, malabsorption, protein losing enteropathies, pancreatic insufficiency, and undernutrition, the infusion of albumin as a source of protein nutrition is not justified.</IndicationAndUsage>
    <Description>Albumin (Human) 25%, USP (Albuked 25) is made from large pools of human venous plasma by the Cohn cold ethanol fractionation process. Part of the fractionation may be performed by another licensed manufacturer. It is prepared in accordance with the applicable requirements established by the U.S. Food and Drug Administration. Albuked 25 is a 25% sterile solution of albumin in an aqueous diluent. The preparation is stabilized with 0.02 M sodium caprylate and 0.02 M acetyltryptophan. The aluminum content of the product is not more than 200 µg/L. The approximate sodium content of the product is 145 mEq/L. Albuked 25 is clear, slightly viscous, almost colorless to yellow, amber or green. It contains no preservative. Albuked 25 must be administered intravenously. Each vial of Albuked 25 is heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses. 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 variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents.(11-14) The production steps from Pooled Plasma to Effluent IV-1 in the Albuked 25 manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>76125-900-20</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (76125-900-20)  &gt; 200 mL in 1 VIAL, GLASS (76125-900-21) </PackageDescription>
    <NDC11Code>76125-0900-20</NDC11Code>
    <ProductNDC>76125-900</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Gammaked</ProprietaryName>
    <NonProprietaryName>Immune Globulin (human)</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20101013</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125046</ApplicationNumber>
    <LabelerName>KEDRION BIOPHARMA, INC.</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101013</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GAMMAKED is an immune globulin injection (human) 10% liquid that is indicated for the treatment of:.</IndicationAndUsage>
    <Description>GAMMAKED is a ready-to-use sterile, non-pyrogenic solution of human immune globulin protein for intravenous and subcutaneous (PI indication only) administration. GAMMAKED is clear to opalescent, and colorless to pale yellow. GAMMAKED 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 GAMMAKED 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. GAMMAKED contains trace levels of fragments, IgA (average 0.046 mg/mL), and IgM. GAMMAKED 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 GAMMAKED. In another study it was demonstrated that intravenous bolus doses of 0.44 g/kg glycine were not associated with serious adverse effects.(21) 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.(22) 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 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 GAMMAKED would be neutralized by the buffering capacity of whole blood alone, even if the dose was infused instantaneously. The pH of GAMMAKED is 4.0–4.5. GAMMAKED contains no preservative. GAMMAKED is not made with natural rubber latex. GAMMAKED 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. GAMMAKED is incubated in the final container (at the low pH of 4.0–4.3). The product is intended for intravenous administration and may be administered subcutaneously in treatment of PI. 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.(23). 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.(23). Several of the individual production steps in the GAMMAKED 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>13733-256-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (13733-256-02)  / 20 mL in 1 TUBE (13733-256-01) </PackageDescription>
    <NDC11Code>13733-0256-02</NDC11Code>
    <ProductNDC>13733-256</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Missha M Perfect Cover Bb No.31</ProprietaryName>
    <NonProprietaryName>Octinoxate, Zinc Oxide, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260115</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Able C&amp;C Co., Ltd.</LabelerName>
    <SubstanceName>ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>7; 7.5; 4.19</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. · Helps prevent sunburn. · If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43744-256-20</NDCCode>
    <PackageDescription>15 g in 1 DRUM (43744-256-20)</PackageDescription>
    <NDC11Code>43744-0256-20</NDC11Code>
    <ProductNDC>43744-256</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Deslorelin Acetate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20120202</StartMarketingDate>
    <EndMarketingDate>20130624</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CBSCHEM LIMITED</LabelerName>
    <SubstanceName>DESLORELIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>43744-256-22</NDCCode>
    <PackageDescription>20 g in 1 DRUM (43744-256-22)</PackageDescription>
    <NDC11Code>43744-0256-22</NDC11Code>
    <ProductNDC>43744-256</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Deslorelin Acetate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20120202</StartMarketingDate>
    <EndMarketingDate>20130624</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CBSCHEM LIMITED</LabelerName>
    <SubstanceName>DESLORELIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>47781-256-17</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (47781-256-17)  &gt; 5 mL in 1 VIAL, SINGLE-DOSE (47781-256-20) </PackageDescription>
    <NDC11Code>47781-0256-17</NDC11Code>
    <ProductNDC>47781-256</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxorubicin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Doxorubicin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20171231</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065515</ApplicationNumber>
    <LabelerName>Alvogen Inc.</LabelerName>
    <SubstanceName>DOXORUBICIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>55289-256-20</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (55289-256-20)</PackageDescription>
    <NDC11Code>55289-0256-20</NDC11Code>
    <ProductNDC>55289-256</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100323</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA060704</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2014-09-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>57687-256-20</NDCCode>
    <PackageDescription>20 mL in 1 BOTTLE, DROPPER (57687-256-20) </PackageDescription>
    <NDC11Code>57687-0256-20</NDC11Code>
    <ProductNDC>57687-256</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bach Original Flower Remedies</ProprietaryName>
    <NonProprietaryName>Aesculus Hippocastanum Whole</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Nelson Bach USA Limited</LabelerName>
    <SubstanceName>AESCULUS HIPPOCASTANUM WHOLE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>[hp_X]/.095mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2020-05-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020101</StartMarketingDatePackage>
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    <IndicationAndUsage>For relief of naturally occurring simple nervous tension.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63187-256-20</NDCCode>
    <PackageDescription>20 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-20) </PackageDescription>
    <NDC11Code>63187-0256-20</NDC11Code>
    <ProductNDC>63187-256</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ondansetron</ProprietaryName>
    <NonProprietaryName>Ondansetron</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070627</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078152</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>ONDANSETRON</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. . Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. . Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. . Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets USP and ondansetron orally disintegrating tablets USP are recommended even where the incidence of postoperative nausea and/or vomiting is low. .</IndicationAndUsage>
    <Description>The active ingredient in ondansetron tablets USP is ondansetron hydrochloride (HCl) USP as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula:. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.85. Ondansetron HCl USP dihydrate is a white to off-white powder that is sparingly soluble in water and in alcohol; soluble in methanol, slightly soluble in isopropyl alcohol, and in dichloromethane; very slightly soluble in acetone, in chloroform and in ethyl acetate. The active ingredient in ondansetron orally disintegrating tablets USP is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula:. The empirical formula is C18H19N3O representing a molecular weight of 293.4. Each 4-mg ondansetron tablet USP for oral administration contains ondansetron HCl USP dihydrate equivalent to 4 mg of ondansetron. Each 8-mg ondansetron tablet USP for oral administration contains ondansetron HCl USP dihydrate equivalent to 8 mg of ondansetron. Each 24-mg ondansetron tablet USP for oral administration contains ondansetron HCl USP dihydrate equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose, iron oxide yellow (8 mg tablet only), iron oxide red (24 mg tablet only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide and triacetin. Each 4-mg ondansetron orally disintegrating tablet USP for oral administration contains 4 mg ondansetron base. Each 8-mg ondansetron orally disintegrating tablet USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet USP also contains the inactive ingredients aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, sodium stearyl fumarate and strawberry flavor. Ondansetron orally disintegrating tablets USP are an orally administered formulation of ondansetron which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing. This product disintegrates in approximately 60 seconds.</Description>
  </NDC>
  <NDC>
    <NDCCode>65427-256-20</NDCCode>
    <PackageDescription>1 BAG in 1 DRUM (65427-256-20)  / 160 TABLET, FILM COATED in 1 BAG</PackageDescription>
    <NDC11Code>65427-0256-20</NDC11Code>
    <ProductNDC>65427-256</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20191121</StartMarketingDate>
    <MarketingCategoryName>EXPORT ONLY</MarketingCategoryName>
    <LabelerName>Pfizer Pharmaceuticals LLC</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-07-15</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>21-NOV-19</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>82804-256-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (82804-256-20) </PackageDescription>
    <NDC11Code>82804-0256-20</NDC11Code>
    <ProductNDC>82804-256</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciprofloxacin</ProprietaryName>
    <NonProprietaryName>Ciprofolxacin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208921</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10), 11 Acute Exacerbation of Chronic Bronchitis, 12 Urinary Tract Infections (1.11), 13 Urinary Tract Infections (UTI), 14 Acute Uncomplicated Cystitis, 15 Complicated UTI and Pyelonephritis in Pediatric Patients, 16 Acute Sinusitis (1.12).</IndicationAndUsage>
    <Description>Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl- 6-fluoro- 1,4-dihydro- 4-oxo- 7-(1-piperazinyl)- 3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl- 6-fluoro- 1,4-dihydro- 4-oxo- 7-(1-piperazinyl)- 3-quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG.</Description>
  </NDC>
  <NDC>
    <NDCCode>76125-791-10</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (76125-791-10)  &gt; 100 mL in 1 VIAL (76125-791-11) </PackageDescription>
    <NDC11Code>76125-0791-10</NDC11Code>
    <ProductNDC>76125-791</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Albuked</ProprietaryName>
    <NonProprietaryName>Albumin (human)</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19810728</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101138</ApplicationNumber>
    <LabelerName>KEDRION BIOPHARMA, INC.</LabelerName>
    <SubstanceName>ALBUMIN HUMAN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19810728</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Emergency Treatment of Hypovolemic Shock. Albuked 20 is hyperoncotic and on intravenous infusion will expand the plasma volume by an additional amount, three to four times the volume actually administered, by withdrawing fluid from the interstitial spaces, provided the patient is normally hydrated interstitially or there is interstitial edema.(1) If the patient is dehydrated, additional crystalloids must be given,(4) or alternatively, Albumin (Human) 5%, USP (Albuked 5) should be used. The patient’s hemodynamic response should be monitored and the usual precautions against circulatory overload observed. The total dose should not exceed the level of albumin found in the normal individual; i.e., about 2 g per kg body weight in the absence of active bleeding. Although Albuked 5 is to be preferred for the usual volume deficits, Albuked 20 with appropriate crystalloids may offer therapeutic advantages in oncotic deficits or in long-standing shock where treatment has been delayed.(2). Removal of ascitic fluid from a patient with cirrhosis may cause changes in cardiovascular function and even result in hypovolemic shock. In such circumstances, the use of an albumin infusion may be required to support the blood volume.(2). Burn Therapy. An optimal therapeutic regimen with respect to the administration of colloids, crystalloids, and water following extensive burns has not been established. During the first 24 hours after sustaining thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours Albuked 20 can be used to maintain plasma colloid osmotic pressure. Hypoproteinemia With or Without Edema. During major surgery, patients can lose over half of their circulating albumin with the attendant complications of oncotic deficit.(2,4,5) A similar situation can occur in sepsis or intensive care patients. Treatment with Albuked 20 may be of value in such cases.(2). Adult Respiratory Distress Syndrome (ARDS)(2,5). This is characterized by deficient oxygenation caused by pulmonary interstitial edema complicating shock and postsurgical conditions. When clinical signs are those of hypoproteinemia with a fluid volume overload, Albuked 20 together with a diuretic may play a role in therapy. Cardiopulmonary Bypass(2,6). With the relatively small priming volume required with modern pumps, preoperative dilution of the blood using albumin and crystalloid has been shown to be safe and well-tolerated. Although the limit to which the hematocrit and plasma protein concentration can be safely lowered has not been defined, it is common practice to adjust the albumin and crystalloid pump prime to achieve a hematocrit of 20% and a plasma albumin concentration of 2.5 g per 100 mL in the patient. Acute Liver Failure(2). In the uncommon situation of rapid loss of liver function with or without coma, administration of albumin may serve the double purpose of supporting the colloid osmotic pressure of the plasma as well as binding excess plasma bilirubin. Neonatal Hemolytic Disease(2,3). The administration of Albuked 20 may be indicated prior to exchange transfusion, in order to bind free bilirubin, thus lessening the risk of kernicterus. A dosage of 1 g/kg body weight is given about 1 hour prior to exchange transfusion. Caution must be observed in hypervolemic infants. Sequestration of Protein Rich Fluids(7). This occurs in such conditions as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis. The magnitude of loss into the third space may require treatment of reduced volume or oncotic activity with an infusion of albumin. Erythrocyte Resuspension(2). Albumin may be required to avoid excessive hypoproteinemia during certain types of exchange transfusion, or with the use of very large volumes of previously frozen or washed red cells. About 25 g of albumin per liter of erythrocytes is commonly used, although the requirements in preexistent hypoproteinemia or hepatic impairment can be greater. Albuked 20 is added to the isotonic suspension of washed red cells immediately prior to transfusion. Acute Nephrosis(2). Certain patients may not respond to cyclophosphamide or steroid therapy. The steroids may even aggravate the underlying edema. In this situation a loop diuretic and 100 mL Albuked 20 repeated daily for 7 to 10 days may be helpful in controlling the edema and the patient may then respond to steroid treatment. Renal Dialysis(2). Although not part of the regular regimen of renal dialysis, Albuked 20 may be of value in the treatment of shock or hypotension in these patients. The usual volume administered is about 100 mL, taking particular care to avoid fluid overload as these patients are often fluid overloaded and cannot tolerate substantial volumes of salt solution. Situations in Which Albumin Administration is Not Warranted(2). In chronic nephrosis, infused albumin is promptly excreted by the kidneys with no relief of the chronic edema or effect on the underlying renal lesion. It is of occasional use in the rapid “priming” diuresis of nephrosis. Similarly, in hypoproteinemic states associated with chronic cirrhosis, malabsorption, protein-losing enteropathies, pancreatic insufficiency, and undernutrition, the infusion of albumin as a source of protein nutrition is not justified.</IndicationAndUsage>
    <Description>Albumin (Human) 20%, USP (Albuked 20) is made from large pools of human venous plasma by the Cohn cold ethanol fractionation process. Part of the fractionation may be performed by another licensed manufacturer. It is prepared in accordance with the applicable requirements established by the U.S. Food and Drug Administration. Albuked 20 is a 20% sterile solution of albumin in an aqueous diluent. The preparation is stabilized with 0.016 M sodium caprylate and 0.016 M acetyltryptophan. The aluminum content of the product is not more than 200 µg/L. The approximate sodium content of the product is 145 mEq/L. Albuked 20 is clear, slightly viscous, almost colorless to yellow, amber or green. It contains no preservative. Albuked 20 must be administered intravenously. Each vial of Albuked 20 is heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses. 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 variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents.(11-14) The production steps from Pooled Plasma to Effluent IV-1 in the Albuked 20 manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>76125-791-50</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (76125-791-50)  &gt; 50 mL in 1 VIAL (76125-791-51) </PackageDescription>
    <NDC11Code>76125-0791-50</NDC11Code>
    <ProductNDC>76125-791</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Albuked</ProprietaryName>
    <NonProprietaryName>Albumin (human)</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19810728</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101138</ApplicationNumber>
    <LabelerName>KEDRION BIOPHARMA, INC.</LabelerName>
    <SubstanceName>ALBUMIN HUMAN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19810728</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Emergency Treatment of Hypovolemic Shock. Albuked 20 is hyperoncotic and on intravenous infusion will expand the plasma volume by an additional amount, three to four times the volume actually administered, by withdrawing fluid from the interstitial spaces, provided the patient is normally hydrated interstitially or there is interstitial edema.(1) If the patient is dehydrated, additional crystalloids must be given,(4) or alternatively, Albumin (Human) 5%, USP (Albuked 5) should be used. The patient’s hemodynamic response should be monitored and the usual precautions against circulatory overload observed. The total dose should not exceed the level of albumin found in the normal individual; i.e., about 2 g per kg body weight in the absence of active bleeding. Although Albuked 5 is to be preferred for the usual volume deficits, Albuked 20 with appropriate crystalloids may offer therapeutic advantages in oncotic deficits or in long-standing shock where treatment has been delayed.(2). Removal of ascitic fluid from a patient with cirrhosis may cause changes in cardiovascular function and even result in hypovolemic shock. In such circumstances, the use of an albumin infusion may be required to support the blood volume.(2). Burn Therapy. An optimal therapeutic regimen with respect to the administration of colloids, crystalloids, and water following extensive burns has not been established. During the first 24 hours after sustaining thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours Albuked 20 can be used to maintain plasma colloid osmotic pressure. Hypoproteinemia With or Without Edema. During major surgery, patients can lose over half of their circulating albumin with the attendant complications of oncotic deficit.(2,4,5) A similar situation can occur in sepsis or intensive care patients. Treatment with Albuked 20 may be of value in such cases.(2). Adult Respiratory Distress Syndrome (ARDS)(2,5). This is characterized by deficient oxygenation caused by pulmonary interstitial edema complicating shock and postsurgical conditions. When clinical signs are those of hypoproteinemia with a fluid volume overload, Albuked 20 together with a diuretic may play a role in therapy. Cardiopulmonary Bypass(2,6). With the relatively small priming volume required with modern pumps, preoperative dilution of the blood using albumin and crystalloid has been shown to be safe and well-tolerated. Although the limit to which the hematocrit and plasma protein concentration can be safely lowered has not been defined, it is common practice to adjust the albumin and crystalloid pump prime to achieve a hematocrit of 20% and a plasma albumin concentration of 2.5 g per 100 mL in the patient. Acute Liver Failure(2). In the uncommon situation of rapid loss of liver function with or without coma, administration of albumin may serve the double purpose of supporting the colloid osmotic pressure of the plasma as well as binding excess plasma bilirubin. Neonatal Hemolytic Disease(2,3). The administration of Albuked 20 may be indicated prior to exchange transfusion, in order to bind free bilirubin, thus lessening the risk of kernicterus. A dosage of 1 g/kg body weight is given about 1 hour prior to exchange transfusion. Caution must be observed in hypervolemic infants. Sequestration of Protein Rich Fluids(7). This occurs in such conditions as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis. The magnitude of loss into the third space may require treatment of reduced volume or oncotic activity with an infusion of albumin. Erythrocyte Resuspension(2). Albumin may be required to avoid excessive hypoproteinemia during certain types of exchange transfusion, or with the use of very large volumes of previously frozen or washed red cells. About 25 g of albumin per liter of erythrocytes is commonly used, although the requirements in preexistent hypoproteinemia or hepatic impairment can be greater. Albuked 20 is added to the isotonic suspension of washed red cells immediately prior to transfusion. Acute Nephrosis(2). Certain patients may not respond to cyclophosphamide or steroid therapy. The steroids may even aggravate the underlying edema. In this situation a loop diuretic and 100 mL Albuked 20 repeated daily for 7 to 10 days may be helpful in controlling the edema and the patient may then respond to steroid treatment. Renal Dialysis(2). Although not part of the regular regimen of renal dialysis, Albuked 20 may be of value in the treatment of shock or hypotension in these patients. The usual volume administered is about 100 mL, taking particular care to avoid fluid overload as these patients are often fluid overloaded and cannot tolerate substantial volumes of salt solution. Situations in Which Albumin Administration is Not Warranted(2). In chronic nephrosis, infused albumin is promptly excreted by the kidneys with no relief of the chronic edema or effect on the underlying renal lesion. It is of occasional use in the rapid “priming” diuresis of nephrosis. Similarly, in hypoproteinemic states associated with chronic cirrhosis, malabsorption, protein-losing enteropathies, pancreatic insufficiency, and undernutrition, the infusion of albumin as a source of protein nutrition is not justified.</IndicationAndUsage>
    <Description>Albumin (Human) 20%, USP (Albuked 20) is made from large pools of human venous plasma by the Cohn cold ethanol fractionation process. Part of the fractionation may be performed by another licensed manufacturer. It is prepared in accordance with the applicable requirements established by the U.S. Food and Drug Administration. Albuked 20 is a 20% sterile solution of albumin in an aqueous diluent. The preparation is stabilized with 0.016 M sodium caprylate and 0.016 M acetyltryptophan. The aluminum content of the product is not more than 200 µg/L. The approximate sodium content of the product is 145 mEq/L. Albuked 20 is clear, slightly viscous, almost colorless to yellow, amber or green. It contains no preservative. Albuked 20 must be administered intravenously. Each vial of Albuked 20 is heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses. 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 variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents.(11-14) The production steps from Pooled Plasma to Effluent IV-1 in the Albuked 20 manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>76125-918-04</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (76125-918-04)  &gt; 50 mL in 1 VIAL, GLASS (76125-918-05)</PackageDescription>
    <NDC11Code>76125-0918-04</NDC11Code>
    <ProductNDC>76125-918</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Bivigam</ProprietaryName>
    <NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20130204</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125389</ApplicationNumber>
    <LabelerName>KEDRION BIOPHARMA, INC.</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/10mL</StrengthUnit>
    <Pharm_Classes>Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of primary humoral immunodeficiency (PI). [1].</IndicationAndUsage>
    <Description>BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human immunoglobulin G (IgG) antibodies. The distribution of IgG subclasses is similar to that of normal plasma. 19,20 The active ingredient is human immunoglobulin purified from source human plasma and processed using a modified classical Cohn Method 6 / Oncley Method 9 fractionation procedure. BIVIGAM contains 100 10 mg/mL protein, of which not less than 96% is human immunoglobulin obtained from source human plasma. It is formulated in water for injection containing 0.100-0.140 M sodium chloride, 0.20-0.29 M glycine, 0.15 0.25% polysorbate 80, and pH 4.0 4.6. BIVIGAM contains ≤ 200 µg/mL of IgA. Each plasma donation used for the manufacture of BIVIGAM is collected from FDA licensed facilities and undergoes rigorous testing. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immuno assay (EIA). In addition, each plasma unit must test negative and/or non-reactive for HIV RNA, HCV RNA, HBV DNA, Hepatitis A Virus (HAV) RNA, and Parvovirus B19 (B19 virus) DNA as determined by Nucleic Acid Amplification Testing (NAT) of plasma minipools. NAT for B19 virus DNA is also performed on a sample of the manufacturing pool and the limit for B19 virus DNA in a manufacturing pool is set not to exceed 104 IU/mL. The manufacturing process of BIVIGAM employs three steps to remove/inactivate adventitious viruses to minimize the risk of virus transmission. The steps are "Precipitation and removal of fraction III" during cold ethanol fractionation, classical "Solvent/detergent treatment" and "35 nm virus filtration". In compliance with current guidelines, the steps have been separately validated in a series of. in vitro experiments for their capacity to inactivate or remove both enveloped and non-enveloped viruses. Precipitation and removal of fraction III removes both enveloped and non-enveloped viruses, solvent/detergent treatment represents a virus inactivation step for enveloped viruses, and 35 nm virus filtration removes both enveloped and non-enveloped viruses by size exclusion. In addition to the steps above, low pH during several steps of the production process contributes to virus inactivation. The results of virus validation studies for BIVIGAM are shown in Table 3, expressed as log10 reduction factors. HIV, human immunodeficiency virus; BVDV, Bovine viral diarrhea virus, model virus for HCV; SinV, Sindbis virus, model virus for HCV; WNV, West Nile virus; PRV, Pseudorabies virus, model virus for herpes viruses and Hepatitis B virus; MEV, Murine encephalomyelitis virus, model virus for hepatitis A virus; BPV, Bovine parvovirus, model virus for human B19 virus; PPV, Porcine parvo virus, model virus for human B19 virus; SV40, Simian virus 40, model virus for highly resistant non- enveloped viruses.</Description>
  </NDC>
  <NDC>
    <NDCCode>76125-918-09</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (76125-918-09)  &gt; 100 mL in 1 VIAL, GLASS (76125-918-10)</PackageDescription>
    <NDC11Code>76125-0918-09</NDC11Code>
    <ProductNDC>76125-918</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Bivigam</ProprietaryName>
    <NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20130204</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125389</ApplicationNumber>
    <LabelerName>KEDRION BIOPHARMA, INC.</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/10mL</StrengthUnit>
    <Pharm_Classes>Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of primary humoral immunodeficiency (PI). [1].</IndicationAndUsage>
    <Description>BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human immunoglobulin G (IgG) antibodies. The distribution of IgG subclasses is similar to that of normal plasma. 19,20 The active ingredient is human immunoglobulin purified from source human plasma and processed using a modified classical Cohn Method 6 / Oncley Method 9 fractionation procedure. BIVIGAM contains 100 10 mg/mL protein, of which not less than 96% is human immunoglobulin obtained from source human plasma. It is formulated in water for injection containing 0.100-0.140 M sodium chloride, 0.20-0.29 M glycine, 0.15 0.25% polysorbate 80, and pH 4.0 4.6. BIVIGAM contains ≤ 200 µg/mL of IgA. Each plasma donation used for the manufacture of BIVIGAM is collected from FDA licensed facilities and undergoes rigorous testing. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immuno assay (EIA). In addition, each plasma unit must test negative and/or non-reactive for HIV RNA, HCV RNA, HBV DNA, Hepatitis A Virus (HAV) RNA, and Parvovirus B19 (B19 virus) DNA as determined by Nucleic Acid Amplification Testing (NAT) of plasma minipools. NAT for B19 virus DNA is also performed on a sample of the manufacturing pool and the limit for B19 virus DNA in a manufacturing pool is set not to exceed 104 IU/mL. The manufacturing process of BIVIGAM employs three steps to remove/inactivate adventitious viruses to minimize the risk of virus transmission. The steps are "Precipitation and removal of fraction III" during cold ethanol fractionation, classical "Solvent/detergent treatment" and "35 nm virus filtration". In compliance with current guidelines, the steps have been separately validated in a series of. in vitro experiments for their capacity to inactivate or remove both enveloped and non-enveloped viruses. Precipitation and removal of fraction III removes both enveloped and non-enveloped viruses, solvent/detergent treatment represents a virus inactivation step for enveloped viruses, and 35 nm virus filtration removes both enveloped and non-enveloped viruses by size exclusion. In addition to the steps above, low pH during several steps of the production process contributes to virus inactivation. The results of virus validation studies for BIVIGAM are shown in Table 3, expressed as log10 reduction factors. HIV, human immunodeficiency virus; BVDV, Bovine viral diarrhea virus, model virus for HCV; SinV, Sindbis virus, model virus for HCV; WNV, West Nile virus; PRV, Pseudorabies virus, model virus for herpes viruses and Hepatitis B virus; MEV, Murine encephalomyelitis virus, model virus for hepatitis A virus; BPV, Bovine parvovirus, model virus for human B19 virus; PPV, Porcine parvo virus, model virus for human B19 virus; SV40, Simian virus 40, model virus for highly resistant non- enveloped viruses.</Description>
  </NDC>
  <NDC>
    <NDCCode>0121-0867-20</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (0121-0867-20)  / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00121-0867-20</NDC11Code>
    <ProductNDC>0121-0867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190725</StartMarketingDate>
    <EndMarketingDate>20250731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210729</ApplicationNumber>
    <LabelerName>PAI Holdings, LLC dba PAI Pharma</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190725</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin Hydrochloride Capsules are indicated for the treatment of C. difficile-associated diarrhea. Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use.  Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections.  Orally administered Vancomycin Hydrochloride Capsules is not effective for other types of infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride Capsules and other antibacterial drugs, Vancomycin Hydrochloride Capsules 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.</IndicationAndUsage>
    <Description>Vancomycin Hydrochloride Capsules USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. The capsules contain 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride). These capsules also contain polyethylene glycol 6000, FD&amp;C Yellow No. 5, titanium dioxide, FD&amp;C Blue No. 1, sodium lauryl sulfate and gelatin. The capsules contain 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). These capsules also contain polyethylene glycol 6000, yellow iron oxide, titanium dioxide, FD&amp;C Blue No. 1, sodium lauryl sulfate, gelatin. Both 125 mg and 250 mg capsules are imprinted with ink which may contain titanium dioxide, carnauba wax, white shellac, glyceryl monooleate. Vancomycin hydrochloride has the structural formula:.</Description>
  </NDC>
  <NDC>
    <NDCCode>0573-0133-20</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0573-0133-20)  / 20 TABLET, COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>00573-0133-20</NDC11Code>
    <ProductNDC>0573-0133</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Advil</ProprietaryName>
    <NonProprietaryName>Ibuprofen Sodium</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130708</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA201803</ApplicationNumber>
    <LabelerName>Haleon US Holdings LLC</LabelerName>
    <SubstanceName>IBUPROFEN SODIUM</SubstanceName>
    <StrengthNumber>256</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130708</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to: headachetoothachebackachemenstrual crampsthe common coldmuscular achesminor pain of arthritis, 2 temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0573-0134-20</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0573-0134-20)  / 20 TABLET, COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>00573-0134-20</NDC11Code>
    <ProductNDC>0573-0134</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Advil</ProprietaryName>
    <NonProprietaryName>Ibuprofen Sodium</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130708</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA201803</ApplicationNumber>
    <LabelerName>Haleon US Holdings LLC</LabelerName>
    <SubstanceName>IBUPROFEN SODIUM</SubstanceName>
    <StrengthNumber>256</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130708</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to: headachetoothachebackachemenstrual crampsthe common coldmuscular achesminor pain of arthritis, 2 temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0573-0230-20</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0573-0230-20)  / 20 TABLET, COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>00573-0230-20</NDC11Code>
    <ProductNDC>0573-0230</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Advil Menstrual Pain</ProprietaryName>
    <NonProprietaryName>Ibuprofen Sodium</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160630</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA201803</ApplicationNumber>
    <LabelerName>Haleon US Holdings LLC</LabelerName>
    <SubstanceName>IBUPROFEN SODIUM</SubstanceName>
    <StrengthNumber>256</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to: menstrual crampsbackacheheadachemuscular achesthe common coldtoothacheminor pain of arthritis. temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>11673-835-60</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (11673-835-60)  &gt; 20 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>11673-0835-60</NDC11Code>
    <ProductNDC>11673-835</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Up And Up Ibuprofen Sodium</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170302</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206581</ApplicationNumber>
    <LabelerName>Target Corporation</LabelerName>
    <SubstanceName>IBUPROFEN SODIUM</SubstanceName>
    <StrengthNumber>256</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-12-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170302</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>21695-300-20</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE (21695-300-20)</PackageDescription>
    <NDC11Code>21695-0300-20</NDC11Code>
    <ProductNDC>21695-300</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrofurantoin (monohydrate/macrocrystals)</ProprietaryName>
    <NonProprietaryName>Nitrofurantoin (monohydrate/macrocrystals)</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19701125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA080043</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN</SubstanceName>
    <StrengthNumber>75; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Nitrofurantoin monohydrate/macrocrystals capsules are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin monohydrate/macrocrystals  and other antibacterial drugs, nitrofurantoin monohydrate/macrocrystals  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. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin monohydrate/macrocrystals  are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES .) Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin monohydrate/macrocrystals, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin monohydrate/macrocrystals, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
    <Description>Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin monohydrate/macrocrystals is a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione. The chemical structure is the following. Molecular Weight: 238.16. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following. Molecular Weight: 256.17. Inactive Ingredients. Each capsule contains carbomer 934P, colloidal silicon dioxide, corn starch, compressible sugar, D&amp;C Yellow #10, edible white ink, FD&amp;C Blue #1, FD&amp;C Red #40, gelatin, lactose monohydrate, magnesium stearate, povidone, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>25021-258-61</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (25021-258-61)  *  10 mL in 1 VIAL (25021-256-10)  *  10 mL in 1 VIAL (25021-257-10) </PackageDescription>
    <NDC11Code>25021-0258-61</NDC11Code>
    <ProductNDC>25021-258</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Melphalan Hydrochloride</ProprietaryName>
    <NonProprietaryName>Melphalan Hydrochloride</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209826</ApplicationNumber>
    <LabelerName>Sagent Pharmaceuticals</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2024-04-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.</IndicationAndUsage>
    <Description>Melphalan, also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or L-sarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent that is active against selected human neoplastic diseases. It is known chemically as 4-[bis(2-chloroethyl)amino]-L-phenylalanine. The molecular formula is C13H18Cl2N2O2 and the molecular weight is 305.20. The structural formula is:. Melphalan is the active L-isomer of the compound and was first synthesized in 1953 by Bergel and Stock; the D-isomer, known as medphalan, is less active against certain animal tumors, and the dose needed to produce effects on chromosomes is larger than that required with the L-isomer. The racemic (DL-) form is known as merphalan or sarcolysin. Melphalan is practically insoluble in water and has a pKa1 of ∼2.5. Melphalan Hydrochloride for Injection is supplied as a sterile, nonpyrogenic, white to off white lyophilized cake or powder. Each single-use vial contains melphalan hydrochloride equivalent to 50 mg melphalan and 20 mg povidone. Melphalan Hydrochloride for Injection is reconstituted using the sterile diluent provided. Each vial of sterile diluent contains sodium citrate 0.2 grams, propylene glycol 6 mL, ethanol (96%) 0.52 mL, and Water for Injection to a total of 10 mL. Melphalan Hydrochloride for Injection is administered intravenously.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-256-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (29300-256-01) </PackageDescription>
    <NDC11Code>29300-0256-01</NDC11Code>
    <ProductNDC>29300-256</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Piroxicam</ProprietaryName>
    <NonProprietaryName>Piroxicam</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208340</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>PIROXICAM</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Piroxicam capsule is a nonsteroidal anti-inflammatory drug indicated for: 1 Relief of the signs and symptoms of osteoarthritis (OA) (1), 2 Relief of the signs and symptoms of rheumatoid arthritis (RA) (1).</IndicationAndUsage>
    <Description>Piroxicam USP is a nonsteroidal anti-inflammatory drug, available as maroon and blue 10 mg capsules and maroon 20 mg capsules for oral administration. The chemical name is 4-hydroxyl-2-methyl-N-2-pyridinyl-2H-1,2,-benzothiazine-3-carboxamide 1,1-dioxide. The molecular weight is 331.35. Its molecular formula is C15H13N3O4S, and it has the following chemical structure. Piroxicam occurs as a white crystalline solid, insoluble in water and anhydrous ethanol. It is slightly soluble in 0.1N sodium hydroxide and soluble in methylene chloride. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8). The inactive ingredients in piroxicam capsules USP include: lactose monohydrate, corn starch, sodium lauryl sulfate, magnesium stearate, gelatin, FD&amp;C Blue 1, D&amp;C Red 33, FD&amp;C Red 40, D&amp;C Red 28, titanium dioxide and trace amount of white edible ink.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-256-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (29300-256-05) </PackageDescription>
    <NDC11Code>29300-0256-05</NDC11Code>
    <ProductNDC>29300-256</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Piroxicam</ProprietaryName>
    <NonProprietaryName>Piroxicam</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208340</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>PIROXICAM</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Piroxicam capsule is a nonsteroidal anti-inflammatory drug indicated for: 1 Relief of the signs and symptoms of osteoarthritis (OA) (1), 2 Relief of the signs and symptoms of rheumatoid arthritis (RA) (1).</IndicationAndUsage>
    <Description>Piroxicam USP is a nonsteroidal anti-inflammatory drug, available as maroon and blue 10 mg capsules and maroon 20 mg capsules for oral administration. The chemical name is 4-hydroxyl-2-methyl-N-2-pyridinyl-2H-1,2,-benzothiazine-3-carboxamide 1,1-dioxide. The molecular weight is 331.35. Its molecular formula is C15H13N3O4S, and it has the following chemical structure. Piroxicam occurs as a white crystalline solid, insoluble in water and anhydrous ethanol. It is slightly soluble in 0.1N sodium hydroxide and soluble in methylene chloride. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8). The inactive ingredients in piroxicam capsules USP include: lactose monohydrate, corn starch, sodium lauryl sulfate, magnesium stearate, gelatin, FD&amp;C Blue 1, D&amp;C Red 33, FD&amp;C Red 40, D&amp;C Red 28, titanium dioxide and trace amount of white edible ink.</Description>
  </NDC>
  <NDC>
    <NDCCode>29300-256-13</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (29300-256-13) </PackageDescription>
    <NDC11Code>29300-0256-13</NDC11Code>
    <ProductNDC>29300-256</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Piroxicam</ProprietaryName>
    <NonProprietaryName>Piroxicam</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208340</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>PIROXICAM</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Piroxicam capsule is a nonsteroidal anti-inflammatory drug indicated for: 1 Relief of the signs and symptoms of osteoarthritis (OA) (1), 2 Relief of the signs and symptoms of rheumatoid arthritis (RA) (1).</IndicationAndUsage>
    <Description>Piroxicam USP is a nonsteroidal anti-inflammatory drug, available as maroon and blue 10 mg capsules and maroon 20 mg capsules for oral administration. The chemical name is 4-hydroxyl-2-methyl-N-2-pyridinyl-2H-1,2,-benzothiazine-3-carboxamide 1,1-dioxide. The molecular weight is 331.35. Its molecular formula is C15H13N3O4S, and it has the following chemical structure. Piroxicam occurs as a white crystalline solid, insoluble in water and anhydrous ethanol. It is slightly soluble in 0.1N sodium hydroxide and soluble in methylene chloride. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8). The inactive ingredients in piroxicam capsules USP include: lactose monohydrate, corn starch, sodium lauryl sulfate, magnesium stearate, gelatin, FD&amp;C Blue 1, D&amp;C Red 33, FD&amp;C Red 40, D&amp;C Red 28, titanium dioxide and trace amount of white edible ink.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-160-20</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (33261-160-20)</PackageDescription>
    <NDC11Code>33261-0160-20</NDC11Code>
    <ProductNDC>33261-160</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrofurantoin Monohydrate/ Macrocrystalline</ProprietaryName>
    <NonProprietaryName>Nitrofurantoin Monohydrate/macrocrystalline</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110525</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020064</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE</SubstanceName>
    <StrengthNumber>25; 75</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Nitrofurantoin monohydrate/macrocrystals capsules is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin monohydrate/macrocrystals capsules and other antibacterial drugs, nitrofurantoin monohydrate/macrocrystals capsules 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. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin monohydrate/macrocrystals capsules are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin monohydrate/macrocrystals Capsules, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin monohydrate/macrocrystals capsules, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
    <Description>Nitrofurantoin is an antibacterial agent specific for urinary tract infections. The nitrofurantoin monohydrate/macrocrystals capsules brand of nitrofurantoin is a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione. The chemical structure is the following. Molecular Weight: 238.16. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following. Molecular Weight: 256.17. Inactive Ingredients: Each capsule contains carbomer 934P, corn starch, compressible sugar, D&amp;C Yellow No. 10, edible gray ink, FD&amp;C Blue No. 1, FD&amp;C Red No. 40, gelatin, lactose, magnesium stearate, povidone, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>35356-256-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35356-256-30)</PackageDescription>
    <NDC11Code>35356-0256-30</NDC11Code>
    <ProductNDC>35356-256</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benicar Hct</ProprietaryName>
    <NonProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120222</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021532</ApplicationNumber>
    <LabelerName>Lake Erie Medical &amp; Surgical Supply DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>20; 12.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-09-26</LastUpdate>
  </NDC>
</NDCList>