RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>0562-7806-05</NDCCode>
    <PackageDescription>5 POUCH in 1 CARTON (0562-7806-05)  / 1 INJECTION, SOLUTION in 1 POUCH (0562-7806-00) </PackageDescription>
    <NDC11Code>00562-7806-05</NDC11Code>
    <ProductNDC>0562-7806</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Micrhogam Ultra-filtered Plus</ProprietaryName>
    <NonProprietaryName>Human Rho(d) Immune Globulin</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20070309</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103777</ApplicationNumber>
    <LabelerName>Kedrion Biopharma Inc</LabelerName>
    <SubstanceName>HUMAN RHO(D) IMMUNE GLOBULIN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070309</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>RhoGAM and MICRhoGAM are immune globulins indicated for use in preventing Rh immunization for: 1 Pregnancy and other obstetrical conditions in Rh-negative women unless the father or baby are conclusively Rh-negative, e.g. delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby, any antepartum fetal-maternal hemorrhage (suspected or proven), actual or threatened pregnancy loss at any stage of gestation and ectopic pregnancy. (1.1), 2 Prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive blood or blood products. (1.2), 3 Limitation of usePregnancy and other obstetrical conditions: In the case of postpartum use, RhoGAM and MICRhoGAM are intended for maternal administration. Do not inject the newborn infant. (1.3).</IndicationAndUsage>
    <Description>RhoGAM and MICRhoGAM Rho(D) Immune Globulin (Human) are sterile solutions containing immunoglobulin G (IgG) anti-D (anti-Rh) for use in preventing Rh immunization. They are manufactured from human plasma containing anti-D from Rh-negative donors immunized with Rh-positive red blood cells. A single dose of RhoGAM contains sufficient anti-D (300 μg or 1500 IU) to suppress the immune response to up to 15 mL of Rh-positive red blood cells.7 A single dose of MICRhoGAM contains sufficient anti-D (50 μg or 250 IU) to suppress the immune response to up to 2.5 mL of Rh-positive red blood cells. The anti-D dose is measured by comparison to the RhoGAM in-house reference standard, the potency of which is established relative to the U.S./World Health Organization/European Pharmacopoeia Standard Anti-D Immunoglobulin Rho(D) Immune Globulin (Human).8. Plasma for RhoGAM is typically sourced from a donor center owned and operated by KEDPlasma LLC., US Lic. No. 1876. All donors are carefully screened by history and laboratory testing to reduce the risk of transmitting blood-borne pathogens from infected donors. Each plasma donation is tested and found to be non-reactive for the presence of hepatitis B surface antigen (HBsAg) and antibodies to hepatitis C (HCV) and human immunodeficiency viruses (HIV) 1 and 2. Additionally, plasma is tested by FDA licensed Nucleic Acid Testing (NAT) for hepatitis B virus (HBV), HCV and HIV-1. Each plasma unit must be negative (non-reactive) in all tests. Plasma is tested by in-process NAT procedures for hepatitis A virus (HAV) and parvovirus B19 (B19) in a minipool format. Only plasma that has passed virus screening is used for production. The NAT procedure for B19 detects all three genotypes based upon sequence alignment of known virus isolates. The limit of B19 DNA in the manufacturing pool is set not to exceed 104 IU per mL. Fractionation of the plasma is performed by a modification of the cold alcohol procedure that has been shown to significantly lower viral titers.3 Following plasma fractionation, a viral clearance filtration step and a viral inactivation step are performed. The viral filtration step removes viruses via a size-exclusion mechanism utilizing a Viresolve 180 nanofiltration membrane (ultrafiltration mode) to remove enveloped and non-enveloped viruses. Following viral filtration, quality control tests (CorrTest and diffusion test) are performed on the Viresolve 180 nanofiltration membrane to ensure filter integrity.9 The viral inactivation step utilizes Triton X-100 and tri-n-butyl phosphate (TNBP) to inactivate enveloped viruses such as HCV, HIV and West Nile Virus (WNV).3,10. The donor selection process, the fractionation process, the viral filtration step and the viral inactivation process increase product safety by reducing the virus load and thus the risk of transmission of enveloped and non-enveloped viruses. Rho(D) Immune Globulin (Human) intended for intramuscular use and prepared by cold alcohol fractionation has not been shown to transmit hepatitis or other infectious diseases.11 There have been no documented cases of infectious disease transmission by RhoGAM or MICRhoGAM. Laboratory spiking studies3,12 have shown that the cumulative viral removal and inactivation capability of the RhoGAM / MICRhoGAM manufacturing process is as follows. The safety of Rho(D) Immune Globulin (Human) has been further shown in an empirical study of viral marker rates in female blood donors in the United States.13 This study revealed that Rh-negative donors, of whom an estimated 55-60% had received Rho(D) Immune Globulin (Human) for pregnancy-related indications, had prevalence and incidence viral marker rates similar to those of Rh-positive female donors who had not received Rho(D) Immune Globulin (Human). The final product contains 5 ± 1% IgG, 2.9 mg/mL sodium chloride, 0.01% Polysorbate 80 (non-animal derived) and 15 mg/mL glycine. Small amounts of IgA, typically less than 15 μg per dose, are present.3 The pH range is 6.20 - 7.00 and IgG purity is &gt; 98%. The product contains no added human serum albumin (HSA), no thimerosal or other preservatives and utilizes a latex-free delivery system. RhoGAM Ultra-Filtered PLUS and MICRhoGAM Ultra-Filtered PLUS are manufactured for Kedrion Biopharma Inc. either by Ortho-Clinical Diagnostics, Inc. or by Kedrion Biopharma Inc. up to the bulk products, and all are filled and packaged by Kedrion Biopharma Inc., 155 Duryea Road, Melville, NY 11747 USA.</Description>
  </NDC>
  <NDC>
    <NDCCode>0562-7806-01</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (0562-7806-01)  / 1 INJECTION, SOLUTION in 1 POUCH (0562-7806-00) </PackageDescription>
    <NDC11Code>00562-7806-01</NDC11Code>
    <ProductNDC>0562-7806</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Micrhogam Ultra-filtered Plus</ProprietaryName>
    <NonProprietaryName>Human Rho(d) Immune Globulin</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20070309</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103777</ApplicationNumber>
    <LabelerName>Kedrion Biopharma Inc</LabelerName>
    <SubstanceName>HUMAN RHO(D) IMMUNE GLOBULIN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070309</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>RhoGAM and MICRhoGAM are immune globulins indicated for use in preventing Rh immunization for: 1 Pregnancy and other obstetrical conditions in Rh-negative women unless the father or baby are conclusively Rh-negative, e.g. delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby, any antepartum fetal-maternal hemorrhage (suspected or proven), actual or threatened pregnancy loss at any stage of gestation and ectopic pregnancy. (1.1), 2 Prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive blood or blood products. (1.2), 3 Limitation of usePregnancy and other obstetrical conditions: In the case of postpartum use, RhoGAM and MICRhoGAM are intended for maternal administration. Do not inject the newborn infant. (1.3).</IndicationAndUsage>
    <Description>RhoGAM and MICRhoGAM Rho(D) Immune Globulin (Human) are sterile solutions containing immunoglobulin G (IgG) anti-D (anti-Rh) for use in preventing Rh immunization. They are manufactured from human plasma containing anti-D from Rh-negative donors immunized with Rh-positive red blood cells. A single dose of RhoGAM contains sufficient anti-D (300 μg or 1500 IU) to suppress the immune response to up to 15 mL of Rh-positive red blood cells.7 A single dose of MICRhoGAM contains sufficient anti-D (50 μg or 250 IU) to suppress the immune response to up to 2.5 mL of Rh-positive red blood cells. The anti-D dose is measured by comparison to the RhoGAM in-house reference standard, the potency of which is established relative to the U.S./World Health Organization/European Pharmacopoeia Standard Anti-D Immunoglobulin Rho(D) Immune Globulin (Human).8. Plasma for RhoGAM is typically sourced from a donor center owned and operated by KEDPlasma LLC., US Lic. No. 1876. All donors are carefully screened by history and laboratory testing to reduce the risk of transmitting blood-borne pathogens from infected donors. Each plasma donation is tested and found to be non-reactive for the presence of hepatitis B surface antigen (HBsAg) and antibodies to hepatitis C (HCV) and human immunodeficiency viruses (HIV) 1 and 2. Additionally, plasma is tested by FDA licensed Nucleic Acid Testing (NAT) for hepatitis B virus (HBV), HCV and HIV-1. Each plasma unit must be negative (non-reactive) in all tests. Plasma is tested by in-process NAT procedures for hepatitis A virus (HAV) and parvovirus B19 (B19) in a minipool format. Only plasma that has passed virus screening is used for production. The NAT procedure for B19 detects all three genotypes based upon sequence alignment of known virus isolates. The limit of B19 DNA in the manufacturing pool is set not to exceed 104 IU per mL. Fractionation of the plasma is performed by a modification of the cold alcohol procedure that has been shown to significantly lower viral titers.3 Following plasma fractionation, a viral clearance filtration step and a viral inactivation step are performed. The viral filtration step removes viruses via a size-exclusion mechanism utilizing a Viresolve 180 nanofiltration membrane (ultrafiltration mode) to remove enveloped and non-enveloped viruses. Following viral filtration, quality control tests (CorrTest and diffusion test) are performed on the Viresolve 180 nanofiltration membrane to ensure filter integrity.9 The viral inactivation step utilizes Triton X-100 and tri-n-butyl phosphate (TNBP) to inactivate enveloped viruses such as HCV, HIV and West Nile Virus (WNV).3,10. The donor selection process, the fractionation process, the viral filtration step and the viral inactivation process increase product safety by reducing the virus load and thus the risk of transmission of enveloped and non-enveloped viruses. Rho(D) Immune Globulin (Human) intended for intramuscular use and prepared by cold alcohol fractionation has not been shown to transmit hepatitis or other infectious diseases.11 There have been no documented cases of infectious disease transmission by RhoGAM or MICRhoGAM. Laboratory spiking studies3,12 have shown that the cumulative viral removal and inactivation capability of the RhoGAM / MICRhoGAM manufacturing process is as follows. The safety of Rho(D) Immune Globulin (Human) has been further shown in an empirical study of viral marker rates in female blood donors in the United States.13 This study revealed that Rh-negative donors, of whom an estimated 55-60% had received Rho(D) Immune Globulin (Human) for pregnancy-related indications, had prevalence and incidence viral marker rates similar to those of Rh-positive female donors who had not received Rho(D) Immune Globulin (Human). The final product contains 5 ± 1% IgG, 2.9 mg/mL sodium chloride, 0.01% Polysorbate 80 (non-animal derived) and 15 mg/mL glycine. Small amounts of IgA, typically less than 15 μg per dose, are present.3 The pH range is 6.20 - 7.00 and IgG purity is &gt; 98%. The product contains no added human serum albumin (HSA), no thimerosal or other preservatives and utilizes a latex-free delivery system. RhoGAM Ultra-Filtered PLUS and MICRhoGAM Ultra-Filtered PLUS are manufactured for Kedrion Biopharma Inc. either by Ortho-Clinical Diagnostics, Inc. or by Kedrion Biopharma Inc. up to the bulk products, and all are filled and packaged by Kedrion Biopharma Inc., 155 Duryea Road, Melville, NY 11747 USA.</Description>
  </NDC>
  <NDC>
    <NDCCode>0562-7806-25</NDCCode>
    <PackageDescription>25 POUCH in 1 CARTON (0562-7806-25)  / 1 INJECTION, SOLUTION in 1 POUCH (0562-7806-00) </PackageDescription>
    <NDC11Code>00562-7806-25</NDC11Code>
    <ProductNDC>0562-7806</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Micrhogam Ultra-filtered Plus</ProprietaryName>
    <NonProprietaryName>Human Rho(d) Immune Globulin</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20070309</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103777</ApplicationNumber>
    <LabelerName>Kedrion Biopharma Inc</LabelerName>
    <SubstanceName>HUMAN RHO(D) IMMUNE GLOBULIN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070309</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>RhoGAM and MICRhoGAM are immune globulins indicated for use in preventing Rh immunization for: 1 Pregnancy and other obstetrical conditions in Rh-negative women unless the father or baby are conclusively Rh-negative, e.g. delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby, any antepartum fetal-maternal hemorrhage (suspected or proven), actual or threatened pregnancy loss at any stage of gestation and ectopic pregnancy. (1.1), 2 Prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive blood or blood products. (1.2), 3 Limitation of usePregnancy and other obstetrical conditions: In the case of postpartum use, RhoGAM and MICRhoGAM are intended for maternal administration. Do not inject the newborn infant. (1.3).</IndicationAndUsage>
    <Description>RhoGAM and MICRhoGAM Rho(D) Immune Globulin (Human) are sterile solutions containing immunoglobulin G (IgG) anti-D (anti-Rh) for use in preventing Rh immunization. They are manufactured from human plasma containing anti-D from Rh-negative donors immunized with Rh-positive red blood cells. A single dose of RhoGAM contains sufficient anti-D (300 μg or 1500 IU) to suppress the immune response to up to 15 mL of Rh-positive red blood cells.7 A single dose of MICRhoGAM contains sufficient anti-D (50 μg or 250 IU) to suppress the immune response to up to 2.5 mL of Rh-positive red blood cells. The anti-D dose is measured by comparison to the RhoGAM in-house reference standard, the potency of which is established relative to the U.S./World Health Organization/European Pharmacopoeia Standard Anti-D Immunoglobulin Rho(D) Immune Globulin (Human).8. Plasma for RhoGAM is typically sourced from a donor center owned and operated by KEDPlasma LLC., US Lic. No. 1876. All donors are carefully screened by history and laboratory testing to reduce the risk of transmitting blood-borne pathogens from infected donors. Each plasma donation is tested and found to be non-reactive for the presence of hepatitis B surface antigen (HBsAg) and antibodies to hepatitis C (HCV) and human immunodeficiency viruses (HIV) 1 and 2. Additionally, plasma is tested by FDA licensed Nucleic Acid Testing (NAT) for hepatitis B virus (HBV), HCV and HIV-1. Each plasma unit must be negative (non-reactive) in all tests. Plasma is tested by in-process NAT procedures for hepatitis A virus (HAV) and parvovirus B19 (B19) in a minipool format. Only plasma that has passed virus screening is used for production. The NAT procedure for B19 detects all three genotypes based upon sequence alignment of known virus isolates. The limit of B19 DNA in the manufacturing pool is set not to exceed 104 IU per mL. Fractionation of the plasma is performed by a modification of the cold alcohol procedure that has been shown to significantly lower viral titers.3 Following plasma fractionation, a viral clearance filtration step and a viral inactivation step are performed. The viral filtration step removes viruses via a size-exclusion mechanism utilizing a Viresolve 180 nanofiltration membrane (ultrafiltration mode) to remove enveloped and non-enveloped viruses. Following viral filtration, quality control tests (CorrTest and diffusion test) are performed on the Viresolve 180 nanofiltration membrane to ensure filter integrity.9 The viral inactivation step utilizes Triton X-100 and tri-n-butyl phosphate (TNBP) to inactivate enveloped viruses such as HCV, HIV and West Nile Virus (WNV).3,10. The donor selection process, the fractionation process, the viral filtration step and the viral inactivation process increase product safety by reducing the virus load and thus the risk of transmission of enveloped and non-enveloped viruses. Rho(D) Immune Globulin (Human) intended for intramuscular use and prepared by cold alcohol fractionation has not been shown to transmit hepatitis or other infectious diseases.11 There have been no documented cases of infectious disease transmission by RhoGAM or MICRhoGAM. Laboratory spiking studies3,12 have shown that the cumulative viral removal and inactivation capability of the RhoGAM / MICRhoGAM manufacturing process is as follows. The safety of Rho(D) Immune Globulin (Human) has been further shown in an empirical study of viral marker rates in female blood donors in the United States.13 This study revealed that Rh-negative donors, of whom an estimated 55-60% had received Rho(D) Immune Globulin (Human) for pregnancy-related indications, had prevalence and incidence viral marker rates similar to those of Rh-positive female donors who had not received Rho(D) Immune Globulin (Human). The final product contains 5 ± 1% IgG, 2.9 mg/mL sodium chloride, 0.01% Polysorbate 80 (non-animal derived) and 15 mg/mL glycine. Small amounts of IgA, typically less than 15 μg per dose, are present.3 The pH range is 6.20 - 7.00 and IgG purity is &gt; 98%. The product contains no added human serum albumin (HSA), no thimerosal or other preservatives and utilizes a latex-free delivery system. RhoGAM Ultra-Filtered PLUS and MICRhoGAM Ultra-Filtered PLUS are manufactured for Kedrion Biopharma Inc. either by Ortho-Clinical Diagnostics, Inc. or by Kedrion Biopharma Inc. up to the bulk products, and all are filled and packaged by Kedrion Biopharma Inc., 155 Duryea Road, Melville, NY 11747 USA.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-7806-10</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-7806-10)  / 500 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-7806-10</NDC11Code>
    <ProductNDC>0264-7806</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19880309</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019635</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19880309</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes and water for hydration. 3% and 5% Sodium Chloride Injections USP are of particular value in severe salt depletion when rapid electrolyte restoration is of paramount importance. The low salt syndrome may occur in the presence of heart failure, renal impairment, during surgery, and postoperatively. In these conditions, chloride loss frequently exceeds sodium loss. These hypertonic sodium chloride solutions are also indicated for the following clinical conditions. : 1  Hyponatremia and hypochloremia due to electrolyte and fluid loss replaced with sodium-free fluids., 2  Drastic dilution of extracellular body fluid following excessive water intake sometimes resulting from multiple enemas or perfusion of irrigating fluids into open venous sinuses during transurethral prostatic resections., 3  Emergency treatment of severe salt depletion due to excess sweating, vomiting, diarrhea and other conditions.</IndicationAndUsage>
    <Description>Each 100 mL of 3% Sodium Chloride Injection USP contains. Sodium Chloride USP 3 g; Water for Injection USP qs. pH: 5.8 (4.5–7.0)     Calculated Osmolarity: 1030 mOsmol/literpH may be adjusted with Hydrochloric Acid NF. Concentration of Electrolytes (mEq/liter): Sodium 513     Chloride 513. Each 100 mL of 5% Sodium Chloride Injection USP contains. Sodium Chloride USP 5 g; Water for Injection USP qs. pH: 5.8 (4.5–7.0)     Calculated Osmolarity: 1710 mOsmol/literpH may be adjusted with Hydrochloric Acid NF. Concentration of Electrolytes (mEq/liter): Sodium 856     Chloride 856. 3% and 5% Sodium Chloride Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.</Description>
  </NDC>
  <NDC>
    <NDCCode>0562-7805-05</NDCCode>
    <PackageDescription>5 POUCH in 1 CARTON (0562-7805-05)  / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00) </PackageDescription>
    <NDC11Code>00562-7805-05</NDC11Code>
    <ProductNDC>0562-7805</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Rhogam Ultra-filtered Plus</ProprietaryName>
    <NonProprietaryName>Human Rho(d) Immune Globulin</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20070309</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103777</ApplicationNumber>
    <LabelerName>Kedrion Biopharma Inc</LabelerName>
    <SubstanceName>HUMAN RHO(D) IMMUNE GLOBULIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070309</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>RhoGAM is an immune globulin indicated for use in preventing Rh immunization for: 1 Pregnancy and other obstetrical conditions in Rh-negative women unless the father or baby are conclusively Rh-negative, e.g. delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby, any antepartum fetal-maternal hemorrhage (suspected or proven), actual or threatened pregnancy loss at any stage of gestation and ectopic pregnancy. (1.1), 2 Prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive blood or blood products. (1.2), 3 Limitation of usePregnancy and other obstetrical conditions: In the case of postpartum use, RhoGAM is intended for maternal administration. Do not inject the newborn infant. (1.3).</IndicationAndUsage>
    <Description>RhoGAM Rho(D) Immune Globulin (Human) is a sterile solution containing immunoglobulin G (IgG) anti-D (anti-Rh) for use in preventing Rh immunization. It is manufactured from human plasma containing anti-D from Rh-negative donors immunized with Rh-positive red blood cells. A single dose of RhoGAM contains sufficient anti-D (300 μg or 1500 IU) to suppress the immune response to up to 15 mL of Rh-positive red blood cells.7 The anti-D dose is measured by comparison to the RhoGAM in-house reference standard, the potency of which is established relative to the U.S./World Health Organization/European Pharmacopoeia Standard Anti-D Immunoglobulin Rho(D) Immune Globulin (Human).8. Plasma for RhoGAM is typically sourced from a donor center owned and operated by KEDPlasma LLC., US Lic. No. 1876. All donors are carefully screened by history and laboratory testing to reduce the risk of transmitting blood-borne pathogens from infected donors. Each plasma donation is tested and found to be non-reactive for the presence of hepatitis B surface antigen (HBsAg) and antibodies to hepatitis C (HCV) and human immunodeficiency viruses (HIV) 1 and 2. Additionally, plasma is tested by FDA licensed Nucleic Acid Testing (NAT) for hepatitis B virus (HBV), HCV and HIV-1. Each plasma unit must be negative (non-reactive) in all tests. Plasma is tested by in-process NAT procedures for hepatitis A virus (HAV) and parvovirus B19 (B19) in a minipool format. Only plasma that has passed virus screening is used for production. The NAT procedure for B19 detects all three genotypes based upon sequence alignment of known virus isolates. The limit of B19 DNA in the manufacturing pool is set not to exceed 104 IU per mL. Fractionation of the plasma is performed by a modification of the cold alcohol procedure that has been shown to significantly lower viral titers.3 Following plasma fractionation, a viral clearance filtration step and a viral inactivation step are performed. The viral filtration step removes both enveloped and non‐enveloped viruses as small as approximately 20 nm via a size-exclusion mechanism. Following viral filtration, quality control tests are performed on the 20 nm filtration membrane to ensure filter integrity. The viral inactivation step (Solvent/Detergent treatment) utilizes Triton X-100 and tri-n-butyl phosphate (TNBP) to inactivate enveloped viruses such as HCV, HIV, HBV and West Nile Virus (WNV).3,9, 10, 11. The donor selection process, the fractionation process, the viral filtration step, the viral inactivation process and other manufacturing process steps increase product safety by reducing the virus load potentially present in the starting material and thus reducing the risk of transmission of enveloped and non-enveloped viruses. Rho(D) Immune Globulin (Human) intended for intramuscular use and prepared by cold alcohol fractionation has not been shown to transmit hepatitis or other infectious diseases.12 There have been no documented cases of infectious disease transmission by RhoGAM. Laboratory spiking studies, performed in accordance with good laboratory practices 3 have shown that the cumulative viral removal and inactivation capability of the RhoGAM manufacturing process is as follows. The safety of Rho(D) Immune Globulin (Human) has been further shown in an empirical study of viral marker rates in female blood donors in the United States.13 This study revealed that Rh-negative donors, of whom an estimated 55-60% had received Rho(D) Immune Globulin (Human) for pregnancy-related indications, had prevalence and incidence viral marker rates similar to those of Rh-positive female donors who had not received Rho(D) Immune Globulin (Human). The final product contains 5 ± 1% IgG, 2.9 mg/mL sodium chloride, 0.01% Polysorbate 80 (non-animal derived) and 15 mg/mL glycine. Small amounts of IgA, typically less than 15 μg per dose, are present.3 The pH range is 6.20 - 7.00 and IgG purity is &gt; 98%. The product contains no added human serum albumin (HSA), no thimerosal or other preservatives and utilizes a latex-free delivery system. RhoGAM Ultra-Filtered PLUS is manufactured by Kedrion Biopharma Inc., 155 Duryea Road, Melville, NY 11747 USA.</Description>
  </NDC>
  <NDC>
    <NDCCode>15631-0562-5</NDCCode>
    <PackageDescription>500 TABLET in 1 CONTAINER (15631-0562-5)</PackageDescription>
    <NDC11Code>15631-0562-05</NDC11Code>
    <ProductNDC>15631-0562</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cimicifuga Racemosa</ProprietaryName>
    <NonProprietaryName>Cimicifuga Racemosa</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151227</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>BLACK COHOSH</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43598-562-05</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (43598-562-05)  &gt; 2 mL in 1 VIAL, SINGLE-DOSE (43598-562-23) </PackageDescription>
    <NDC11Code>43598-0562-05</NDC11Code>
    <ProductNDC>43598-562</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paricalcitol</ProprietaryName>
    <NonProprietaryName>Paricalcitol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20160906</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204910</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories, Inc.</LabelerName>
    <SubstanceName>PARICALCITOL</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160906</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paricalcitol injection is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis.</IndicationAndUsage>
    <Description>Paricalcitol, USP, is a synthetically manufactured active vitamin D analog. It is a white powder chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula. Molecular formula is C27H44O3. Molecular weight is 416.64. Paricalcitol injection, USP is a sterile, clear, colorless, aqueous solution for intravenous use. Each mL contains paricalcitol, 2 mcg or 5 mcg and the following inactive ingredients: dehydrated alcohol, 20% (v/v), propylene glycol, 30% (v/v) and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0562-5</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0562-5)</PackageDescription>
    <NDC11Code>49288-0562-05</NDC11Code>
    <ProductNDC>49288-0562</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trichoderma</ProprietaryName>
    <NonProprietaryName>Trichoderma</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19920413</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>TRICHODERMA VIRIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
  </NDC>
  <NDC>
    <NDCCode>49884-562-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (49884-562-05) </PackageDescription>
    <NDC11Code>49884-0562-05</NDC11Code>
    <ProductNDC>49884-562</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamotrigine Extended Release</ProprietaryName>
    <NonProprietaryName>Lamotrigine Extended Release</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201791</ApplicationNumber>
    <LabelerName>Par Health USA, LLC</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lamotrigine extended-release is indicated for: 1 adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. (1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). (1.2).</IndicationAndUsage>
    <Description>Lamotrigine Extended-Release, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine Extended-Release Tablets are supplied for oral administration as 25 mg (round beige biconvex film-coated), 50 mg (round white biconvex film-coated), 100 mg (round brown biconvex film-coated), 200 mg (round yellow biconvex film-coated), 250 mg (round white biconvex film coated) and 300 mg (round grey biconvex film-coated) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, colloidal anhydrous silica (25 mg, 50 mg, 200 mg, 250 mg and 300 mg tablets only), methacrylic acid copolymer, talc, titanium dioxide, triethyl citrate, sodium bicarbonate, sodium laurel sulfate, iron oxide yellow (25 mg and 100 mg tablets only), iron oxide red (25 mg and 100 mg tablets only), D&amp;C Yellow # 10 (200 mg tablet only), FD&amp;C Yellow # 6 (200 mg tablet only) and black iron oxide (300 mg tablet only). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with an enteric coat and have pore forming ingredient in the coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of the modified-release core and the enteric coat are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels.</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-562-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (59746-562-05) </PackageDescription>
    <NDC11Code>59746-0562-05</NDC11Code>
    <ProductNDC>59746-562</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Celecoxib</ProprietaryName>
    <NonProprietaryName>Celecoxib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170404</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207061</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CELECOXIB</SubstanceName>
    <StrengthNumber>100</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>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170404</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Celecoxib capsules are indicated.</IndicationAndUsage>
    <Description>Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzene sulfonamide and is a diaryl-substituted pyrazole. The molecular formula is C17H14F3N3O2S, and the molecular weight is 381.37; the chemical structure is as follows. Celecoxib USP is a white or almost white, crystalline or amorphous powder. It is soluble in ethanol, methylene chloride and is practically insoluble in water.   Celecoxib capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib USP, together with inactive ingredients including: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, and sodium lauryl sulfate.   The 50 mg, 100 mg, 200 mg and 400 mg capsule shell contains: gelatin and titanium dioxide.   The printing ink contains: shellac and propylene glycol, in addition 50 mg capsule printing ink contains ferric oxide red, 100 mg capsule printing ink contains FD&amp;C blue #2 aluminum lake, 200 mg capsule printing ink contains ferric oxide yellow, 400 mg capsule printing ink contains FD&amp;C blue #2 aluminum lake, ferric oxide yellow, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-562-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (63304-562-05) </PackageDescription>
    <NDC11Code>63304-0562-05</NDC11Code>
    <ProductNDC>63304-562</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
    <NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19781116</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA085868</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
    <StrengthNumber>300; 30</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19781116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Acetaminophen and Codeine Phosphate Tablets, USP are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Acetaminophen and Codeine Phosphate Tablets, USP for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: 1 Have not provided adequate analgesia, or are not expected to provide adequate analgesia,, 2 Have not been tolerated, or are not expected to be tolerated.</IndicationAndUsage>
    <Description>Each tablet contains. #3 Codeine Phosphate, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 mg. Acetaminophen, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ……300 mg. or. #4 Codeine Phosphate, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 mg. Acetaminophen, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ……. 300 mg. Inactive ingredients are magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate. Acetaminophen, USP, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Its structure is as follows. Codeine is an alkaloid, obtained from opium or prepared from morphine by methylation. Codeine phosphate, USP occurs as fine, white, needle-shaped crystals, or white, crystalline powder. It is affected by light. Its chemical name is: 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Its structure is as follows:C18H21NO3.H3PO4½H2O M.W. 406.37. C18H21NO3.H3PO4½H2O M.W. 406.37.</Description>
  </NDC>
  <NDC>
    <NDCCode>65585-562-05</NDCCode>
    <PackageDescription>3785 mL in 1 BOTTLE, PLASTIC (65585-562-05) </PackageDescription>
    <NDC11Code>65585-0562-05</NDC11Code>
    <ProductNDC>65585-562</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Whiskcare 362</ProprietaryName>
    <NonProprietaryName>Chloroxylenol</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20060123</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Whisk Products, Inc.</LabelerName>
    <SubstanceName>CHLOROXYLENOL</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-12-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces amount of bacteria on hands.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67877-562-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (67877-562-05)</PackageDescription>
    <NDC11Code>67877-0562-05</NDC11Code>
    <ProductNDC>67877-562</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hcl</ProprietaryName>
    <NonProprietaryName>Metformin Hcl</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090564</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>850</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2017-02-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin Hydrochloride Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin Hydrochloride Tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients povidone (K-30), povidone (K-90), pregelatinized starch,and magnesium stearate. In addition, the coating for the tablets contains artificial blackberry flavor, hypromellose and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-562-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (68382-562-05) </PackageDescription>
    <NDC11Code>68382-0562-05</NDC11Code>
    <ProductNDC>68382-562</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
    <NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260521</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219252</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
    <SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260521</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
    <Description>Verapamil hydrochloride extended-release tablets, USP (verapamil hydrochloride) is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). Verapamil hydrochloride extended-release tablets, USP are available for oral administration as beige colored, biconvex, modified capsule shaped, scored, film-coated tablets containing 240 mg of verapamil hydrochloride (equivalent to 222.16 mg verapamil free base); as beige colored, oval shaped, biconvex, scored, film-coated tablets containing 180 mg of verapamil hydrochloride (equivalent to 166.62 mg verapamil free base); and as light beige colored, oval shaped, biconvex, film-coated tablets containing 120 mg of verapamil hydrochloride (equivalent to 111.08 mg verapamil free base). The tablets are designed for extended-release of the drug in the gastrointestinal tract; extended-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil HCl, USP is. C27H39ClN2O4                 M.W = 491.06. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil HCl, USP is white or practically white crystalline powder. Is practically odourless and has a bitter taste. It is soluble in water, freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in ether. Verapamil HCl, USP is not chemically related to other cardioactive drugs. Inactive ingredients include hypromellose, isopropyl alcohol, magnesium stearate, macrogol, microcrystalline cellulose 102, povidone, sodium alginate, talc, titanium dioxide and coloring agents: - iron oxide yellow and iron oxide red. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>68428-562-05</NDCCode>
    <PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-562-05) </PackageDescription>
    <NDC11Code>68428-0562-05</NDC11Code>
    <ProductNDC>68428-562</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Physostigma Venenosum</ProprietaryName>
    <NonProprietaryName>Physostigma Venenosum Seed</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100316</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>PHYSOSTIGMA VENENOSUM SEED</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-04-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100316</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71335-0562-5</NDCCode>
    <PackageDescription>180 TABLET in 1 BOTTLE (71335-0562-5) </PackageDescription>
    <NDC11Code>71335-0562-05</NDC11Code>
    <ProductNDC>71335-0562</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202557</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-03-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220316</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>84522-562-05</NDCCode>
    <PackageDescription>100 g in 1 BOX (84522-562-05) </PackageDescription>
    <NDC11Code>84522-0562-05</NDC11Code>
    <ProductNDC>84522-562</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Trstay Pearl Cream</ProprietaryName>
    <NonProprietaryName>Trstay Pearl Cream</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241228</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Yucheng E Commerce Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84756-562-05</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (84756-562-05) </PackageDescription>
    <NDC11Code>84756-0562-05</NDC11Code>
    <ProductNDC>84756-562</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Anti-loss And Repair Hair Mask</ProprietaryName>
    <NonProprietaryName>Anti-loss And Repair Hair Mask</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241202</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M032</ApplicationNumber>
    <LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
    <SubstanceName>MINOXIDIL</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0135-0562-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0135-0562-01)  *  96 TABLET, CHEWABLE in 1 BOTTLE *  8 TABLET, CHEWABLE in 1 PACKAGE</PackageDescription>
    <NDC11Code>00135-0562-01</NDC11Code>
    <ProductNDC>0135-0562</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tums</ProprietaryName>
    <ProprietaryNameSuffix>Ex</ProprietaryNameSuffix>
    <NonProprietaryName>Calcium Carbonate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20130415</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part331</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Consumer Heathcare LP</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2014-09-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>11344-562-50</NDCCode>
    <PackageDescription>710 mL in 1 BOTTLE, DISPENSING (11344-562-50) </PackageDescription>
    <NDC11Code>11344-0562-50</NDC11Code>
    <ProductNDC>11344-562</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Chloroxylenol</ProprietaryName>
    <NonProprietaryName>Chloroxylenol 0.3%</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150429</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Vi-Jon, LLC</LabelerName>
    <SubstanceName>CHLOROXYLENOL</SubstanceName>
    <StrengthNumber>3.09</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>11344-562-68</NDCCode>
    <PackageDescription>1650 mL in 1 BOTTLE, DISPENSING (11344-562-68) </PackageDescription>
    <NDC11Code>11344-0562-68</NDC11Code>
    <ProductNDC>11344-562</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Chloroxylenol</ProprietaryName>
    <NonProprietaryName>Chloroxylenol 0.3%</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150429</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Vi-Jon, LLC</LabelerName>
    <SubstanceName>CHLOROXYLENOL</SubstanceName>
    <StrengthNumber>3.09</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>11673-562-58</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (11673-562-58)  / 14 g in 1 TUBE</PackageDescription>
    <NDC11Code>11673-0562-58</NDC11Code>
    <ProductNDC>11673-562</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Up And Up Multi Action Antibiotic</ProprietaryName>
    <NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, Polymyxin B, Pramoxine Hcl</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170511</StartMarketingDate>
    <EndMarketingDate>20250430</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M004</ApplicationNumber>
    <LabelerName>Target Corporation</LabelerName>
    <SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500; 3.5; 10000; 10</StrengthNumber>
    <StrengthUnit>[USP'U]/g; mg/g; [USP'U]/g; mg/g</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis &amp; Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170511</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>first aid to help prevent infection and for temporary relief of pain or discomfort in minor: 1 cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>47593-562-11</NDCCode>
    <PackageDescription>3780 mL in 1 BOTTLE, PLASTIC (47593-562-11)</PackageDescription>
    <NDC11Code>47593-0562-11</NDC11Code>
    <ProductNDC>47593-562</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Swisher</ProprietaryName>
    <NonProprietaryName>Triclosan</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160202</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Ecolab Inc.</LabelerName>
    <SubstanceName>TRICLOSAN</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-10-05</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>49884-562-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (49884-562-01) </PackageDescription>
    <NDC11Code>49884-0562-01</NDC11Code>
    <ProductNDC>49884-562</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamotrigine Extended Release</ProprietaryName>
    <NonProprietaryName>Lamotrigine Extended Release</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201791</ApplicationNumber>
    <LabelerName>Par Health USA, LLC</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lamotrigine extended-release is indicated for: 1 adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. (1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). (1.2).</IndicationAndUsage>
    <Description>Lamotrigine Extended-Release, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine Extended-Release Tablets are supplied for oral administration as 25 mg (round beige biconvex film-coated), 50 mg (round white biconvex film-coated), 100 mg (round brown biconvex film-coated), 200 mg (round yellow biconvex film-coated), 250 mg (round white biconvex film coated) and 300 mg (round grey biconvex film-coated) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, colloidal anhydrous silica (25 mg, 50 mg, 200 mg, 250 mg and 300 mg tablets only), methacrylic acid copolymer, talc, titanium dioxide, triethyl citrate, sodium bicarbonate, sodium laurel sulfate, iron oxide yellow (25 mg and 100 mg tablets only), iron oxide red (25 mg and 100 mg tablets only), D&amp;C Yellow # 10 (200 mg tablet only), FD&amp;C Yellow # 6 (200 mg tablet only) and black iron oxide (300 mg tablet only). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with an enteric coat and have pore forming ingredient in the coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of the modified-release core and the enteric coat are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-0562-0</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (50090-0562-0)  / 28 g in 1 TUBE</PackageDescription>
    <NDC11Code>50090-0562-00</NDC11Code>
    <ProductNDC>50090-0562</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Clotrimazole</ProprietaryName>
    <NonProprietaryName>Clotrimazole</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110603</StartMarketingDate>
    <EndMarketingDate>20270430</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>CLOTRIMAZOLE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20141128</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>cures most athlete’s foot, jock itch and ringworm. relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51079-562-03</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 CARTON (51079-562-03)  &gt; 1 TABLET in 1 BLISTER PACK (51079-562-01) </PackageDescription>
    <NDC11Code>51079-0562-03</NDC11Code>
    <ProductNDC>51079-562</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Modafinil</ProprietaryName>
    <NonProprietaryName>Modafinil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120906</StartMarketingDate>
    <EndMarketingDate>20200430</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076594</ApplicationNumber>
    <LabelerName>Mylan Institutional Inc.</LabelerName>
    <SubstanceName>MODAFINIL</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2020-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20120906</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>58281-562-01</NDCCode>
    <PackageDescription>1 AMPULE in 1 CARTON (58281-562-01)  &gt; 1 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>58281-0562-01</NDC11Code>
    <ProductNDC>58281-562</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lioresal</ProprietaryName>
    <NonProprietaryName>Baclofen</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRATHECAL</RouteName>
    <StartMarketingDate>19961107</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020075</ApplicationNumber>
    <LabelerName>Medtronic Neuromodulation</LabelerName>
    <SubstanceName>BACLOFEN</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <Description>LIORESAL® INTRATHECAL (baclofen injection) is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid, and its structural formula is:. Baclofen is a white to off-white, odorless or practically odorless crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. LIORESAL INTRATHECAL is a sterile, pyrogen-free, isotonic solution free of antioxidants, preservatives or other potentially neurotoxic additives indicated only for intrathecal administration. The drug is stable in solution at 37° C and compatible with CSF. Each milliliter of LIORESAL INTRATHECAL contains baclofen  U.S.P. 50 mcg, 500 mcg or 2000 mcg and sodium chloride 9 mg in Water for Injection; pH range is 5.0-7.0. Each ampule is intended for SINGLE USE ONLY. Discard any unused portion. DO NOT AUTOCLAVE.</Description>
  </NDC>
  <NDC>
    <NDCCode>59212-562-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (59212-562-10) </PackageDescription>
    <NDC11Code>59212-0562-10</NDC11Code>
    <ProductNDC>59212-562</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Plaquenil</ProprietaryName>
    <NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130628</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
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    <LabelerName>Advanz Pharma (US) Corp.</LabelerName>
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    <IndicationAndUsage>PLAQUENIL is an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1) Treatment of rheumatoid arthritis in adults.(1.2) Treatment of systemic lupus erythematosus in adults.(1.3) Treatment of chronic discoid lupus erythematosus in adults. (1.4) Limitations of Use (1.1):PLAQUENIL is not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.</IndicationAndUsage>
    <Description>PLAQUENIL (hydroxychloroquine sulfate) is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4- quinolyl) amino]pentyl] ethylamino]ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate is a white or off-white crystalline powder, freely soluble in water; practically soluble in alcohol, chloroform, and ether.  PLAQUENIL (hydroxychloroquine sulfate) tablets for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: black iron oxide, carnauba wax, corn starch, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide.</Description>
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    <IndicationAndUsage>PLAQUENIL is an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1) Treatment of rheumatoid arthritis in adults.(1.2) Treatment of systemic lupus erythematosus in adults.(1.3) Treatment of chronic discoid lupus erythematosus in adults. (1.4) Limitations of Use (1.1):PLAQUENIL is not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.</IndicationAndUsage>
    <Description>PLAQUENIL (hydroxychloroquine sulfate) is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4- quinolyl) amino]pentyl] ethylamino]ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate is a white or off-white crystalline powder, freely soluble in water; practically soluble in alcohol, chloroform, and ether.  PLAQUENIL (hydroxychloroquine sulfate) tablets for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: black iron oxide, carnauba wax, corn starch, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide.</Description>
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    <LabelerName>Advanz Pharma (US) Corp.</LabelerName>
    <SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
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    <IndicationAndUsage>PLAQUENIL is an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1) Treatment of rheumatoid arthritis in adults.(1.2) Treatment of systemic lupus erythematosus in adults.(1.3) Treatment of chronic discoid lupus erythematosus in adults. (1.4) Limitations of Use (1.1):PLAQUENIL is not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.</IndicationAndUsage>
    <Description>PLAQUENIL (hydroxychloroquine sulfate) is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4- quinolyl) amino]pentyl] ethylamino]ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate is a white or off-white crystalline powder, freely soluble in water; practically soluble in alcohol, chloroform, and ether.  PLAQUENIL (hydroxychloroquine sulfate) tablets for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: black iron oxide, carnauba wax, corn starch, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide.</Description>
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