RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>81665-104-96</NDCCode>
    <PackageDescription>12 POUCH in 1 CARTON (81665-104-96)  / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>81665-0104-96</NDC11Code>
    <ProductNDC>81665-104</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cromolyn Sodium</ProprietaryName>
    <NonProprietaryName>Cromolyn Sodium</NonProprietaryName>
    <DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240831</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209264</ApplicationNumber>
    <LabelerName>Omnivium Pharmaceuticals LLC</LabelerName>
    <SubstanceName>CROMOLYN SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240831</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cromolyn Sodium Oral Solution (Concentrate) is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.</IndicationAndUsage>
    <Description>Each 5 mL ampule of Cromolyn Sodium Oral Solution (Concentrate) contains 100 mg cromolyn sodium, USP, in purified water. Cromolyn sodium is a hygroscopic, white powder having little odor. It may leave a slightly bitter aftertaste. Cromolyn Sodium Oral Solution (Concentrate) is clear, colorless, and sterile. It is intended for oral use. Chemically, cromolyn sodium is disodium 5,5’-[(2-hydroxy-trimethylene) dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]. The empirical formula is C23H14Na2O11; the molecular weight is 512.34. Its chemical structure is. Pharmacologic Category: Mast cell stabilizer. Therapeutic Category: Antiallergic.</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-100-12</NDCCode>
    <PackageDescription>120 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-100-12) </PackageDescription>
    <NDC11Code>81665-0100-12</NDC11Code>
    <ProductNDC>81665-100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200611</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212688</ApplicationNumber>
    <LabelerName>Omnivium Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221024</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older.</IndicationAndUsage>
    <Description>Levetiracetam extended-release tablets are an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: hypromellose, magnesium stearate, colloidal silicon dioxide, titanium dioxide, and triacetin. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-100-60</NDCCode>
    <PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-100-60) </PackageDescription>
    <NDC11Code>81665-0100-60</NDC11Code>
    <ProductNDC>81665-100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200611</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212688</ApplicationNumber>
    <LabelerName>Omnivium Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200611</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older.</IndicationAndUsage>
    <Description>Levetiracetam extended-release tablets are an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: hypromellose, magnesium stearate, colloidal silicon dioxide, titanium dioxide, and triacetin. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-101-12</NDCCode>
    <PackageDescription>120 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-101-12) </PackageDescription>
    <NDC11Code>81665-0101-12</NDC11Code>
    <ProductNDC>81665-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230505</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212688</ApplicationNumber>
    <LabelerName>Omnivium Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230505</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older.</IndicationAndUsage>
    <Description>Levetiracetam extended-release tablets are an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: hypromellose, magnesium stearate, colloidal silicon dioxide, titanium dioxide, and triacetin. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-101-60</NDCCode>
    <PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-101-60) </PackageDescription>
    <NDC11Code>81665-0101-60</NDC11Code>
    <ProductNDC>81665-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230505</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212688</ApplicationNumber>
    <LabelerName>Omnivium Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230505</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older.</IndicationAndUsage>
    <Description>Levetiracetam extended-release tablets are an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: hypromellose, magnesium stearate, colloidal silicon dioxide, titanium dioxide, and triacetin. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>44206-458-24</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (44206-458-24)  / 20 mL in 1 SYRINGE (44206-458-96) </PackageDescription>
    <NDC11Code>44206-0458-24</NDC11Code>
    <ProductNDC>44206-458</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Hizentra</ProprietaryName>
    <NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20200101</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125350</ApplicationNumber>
    <LabelerName>CSL Behring AG</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-05-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions.</IndicationAndUsage>
    <Description>HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid, is a ready-to-use, sterile 20% (0.2 g/mL) protein liquid preparation of polyvalent human immunoglobulin G (IgG) for subcutaneous administration. HIZENTRA is manufactured from large pools of human plasma by a combination of cold alcohol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). The IgG subclass distribution is similar to that of normal human plasma. HIZENTRA has a purity of ≥98% IgG and a pH of 4.6 to 5.2. This product contains approximately 250 mmol/L (range: 210 to 290 mmol/L) L-proline (a nonessential amino acid) as a stabilizer, 8 to 30 mg/L polysorbate 80, and trace amounts of sodium. HIZENTRA contains ≤50 mcg/mL IgA, no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. Plasma units used in the manufacture of HIZENTRA are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus (HIV)-1/2 and hepatitis C virus (HCV) as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1. All plasma units have been found to be nonreactive (negative) in these tests. In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passes virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for HIZENTRA includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses, and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.12. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for HIZENTRA, expressed as the mean log10 reduction factor (LRF).</Description>
  </NDC>
  <NDC>
    <NDCCode>68002-104-04</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 CARTON (68002-104-04)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (68002-104-02) </PackageDescription>
    <NDC11Code>68002-0104-04</NDC11Code>
    <ProductNDC>68002-104</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clarithromycin</ProprietaryName>
    <NonProprietaryName>Clarithromycin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260304</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065489</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>CLARITHROMYCIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260304</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: 1 Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1), 2 Acute Maxillary Sinusitis (1.2), 3 Community-Acquired Pneumonia (1.3), 4 Pharyngitis/Tonsillitis (1.4), 5 Uncomplicated Skin and Skin Structure Infections (1.5), 6 Acute Otitis Media in Pediatric Patients (1.6), 7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7), 8 Helicobacter pyloriInfection and Duodenal Ulcer Disease in Adults (1.8).</IndicationAndUsage>
    <Description>Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0-methylerythromycin. The molecular formula is C 38H 69NO 13, and the molecular weight is 747.96. The structural formula is:. Figure 1: Structure of Clarithromycin. Clarithromycin USP is a white or almost white, crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each film-coated tablet contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, hypromellose, titanium dioxide, hydroxypropyl cellulose, iron oxide yellow, propylene glycol, vanillin, and sorbic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>69152-0104-1</NDCCode>
    <PackageDescription>96 PELLET in 1 BOTTLE (69152-0104-1)</PackageDescription>
    <NDC11Code>69152-0104-01</NDC11Code>
    <ProductNDC>69152-0104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sloth 40 (number 104)</ProprietaryName>
    <NonProprietaryName>Argentum Metallicum, Rhus Toxicodendron</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141113</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Paramesh Banerji Life Sciences LLC</LabelerName>
    <SubstanceName>SILVER NITRATE; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
    <StrengthNumber>200; 200</StrengthNumber>
    <StrengthUnit>[hp_C]/1; [hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Treats lethargy, lack of energy, sleepiness during the day.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70278-104-02</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (70278-104-02)  &gt; 30 mL in 1 VIAL (70278-104-01) </PackageDescription>
    <NDC11Code>70278-0104-02</NDC11Code>
    <ProductNDC>70278-104</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meropenem</ProprietaryName>
    <NonProprietaryName>Meropenem</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20161008</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204854</ApplicationNumber>
    <LabelerName>Daewoong America Inc.</LabelerName>
    <SubstanceName>MEROPENEM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/30mL</StrengthUnit>
    <Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161008</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Meropenem for injection is a penem antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). ( 1.1) , 2 Complicated intra-abdominal infections (adult and pediatric patients). ( 1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older only). (  1.3)  .</IndicationAndUsage>
    <Description>Meropenem for Injection, USP is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl] thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its molecular formula is C 17H 25N 3O 5S3H 2O with a molecular weight of 437.52. Its structural formula is:. Meropenem for Injection, USP is a white to light yellowish crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 1 gram Meropenem for Injection, USP vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq). Each 500 mg Meropenem for Injection, USP vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq) [see Dosage and Administration ( 2.4)] .</Description>
  </NDC>
  <NDC>
    <NDCCode>72526-104-11</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (72526-104-11)  *  2 mL in 1 VIAL, SINGLE-DOSE (72526-204-01)  *  2 mL in 1 SYRINGE, GLASS (72526-801-01) </PackageDescription>
    <NDC11Code>72526-0104-11</NDC11Code>
    <ProductNDC>72526-104</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rykindo</ProprietaryName>
    <ProprietaryNameSuffix>Extended-release Microspheres</ProprietaryNameSuffix>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20230620</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA212849</ApplicationNumber>
    <LabelerName>Shandong Luye Pharmaceutical Co., Ltd.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230620</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>RYKINDO is indicated: 1 for the treatment of schizophrenia in adults, 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.</IndicationAndUsage>
    <Description>RYKINDO contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl] ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. RYKINDO is provided as a single-dose kit consisting of: a vial containing a white to almost white powder, a pre-filled syringe containing 2 mL of a colorless, clear diluent, a vial adapter, and a needle (a 20 gauge 2-inch needle with needle protection device). The vial contains a white to almost white sterile powder containing risperidone. The powder consists of risperidone, mannitol (5.38 mg/100 mg risperidone), polylactide-co-glycolide (PLGA) 5050 (24.2 mg/100 mg risperidone) and polylactide-co-glycolide (PLGA) 7525 (96.7 mg/100 mg risperidone). The diluent is a sterile, clear, colorless, 2 mL solution. The diluent contains: 1.10 mg/mL citric acid monohydrate, 1.02 mg/mL dibasic sodium phosphate anhydrous, 1 mg/mL polysorbate 80, 9 mg/mL sodium carboxymethyl cellulose, 7.5 mg/mL sodium chloride, 0.54 mg/mL sodium hydroxide, and water. RYKINDO (risperidone) for extended-release injectable suspension, for intramuscular use is, when fully mixed, a white suspension, available in strengths of 25 mg, 37.5 mg, or 50 mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>82804-104-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (82804-104-30) </PackageDescription>
    <NDC11Code>82804-0104-30</NDC11Code>
    <ProductNDC>82804-104</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210907</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
    <Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is N-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-1,1-cyclopentanediacetamide monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 10 mg of buspirone hydrochloride, USP (equivalent to 9.1 mg of buspirone free base, respectively). The 10 mg tablets are scored so they can be bisected. Thus, the 10 mg tablet can provide a 5 mg dose. Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>82804-104-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (82804-104-60) </PackageDescription>
    <NDC11Code>82804-0104-60</NDC11Code>
    <ProductNDC>82804-104</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210907</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250814</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
    <Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is N-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-1,1-cyclopentanediacetamide monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 10 mg of buspirone hydrochloride, USP (equivalent to 9.1 mg of buspirone free base, respectively). The 10 mg tablets are scored so they can be bisected. Thus, the 10 mg tablet can provide a 5 mg dose. Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>82804-104-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (82804-104-90) </PackageDescription>
    <NDC11Code>82804-0104-90</NDC11Code>
    <ProductNDC>82804-104</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210907</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260812</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
    <Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is N-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-1,1-cyclopentanediacetamide monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 10 mg of buspirone hydrochloride, USP (equivalent to 9.1 mg of buspirone free base, respectively). The 10 mg tablets are scored so they can be bisected. Thus, the 10 mg tablet can provide a 5 mg dose. Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-102-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (81665-102-10) </PackageDescription>
    <NDC11Code>81665-0102-10</NDC11Code>
    <ProductNDC>81665-102</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
    <NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240502</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020215</ApplicationNumber>
    <LabelerName>OMNIVIUM PHARMACEUTICALS LLC.</LabelerName>
    <SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240502</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Isosorbide Mononitrate Tablets are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
    <Description>Isosorbide mononitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The empirical formula is C6H9NO6 and the molecular weight is 191.14. The chemical name for isosorbide mononitrate is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate and the compound has the following structural formula. Isosorbide Mononitrate Tablets, USP are available as 10 mg and 20 mg tablets. Each tablet also contains as inactive ingredients: lactose, talc, colloidal silicon dioxide, starch, microcrystalline cellulose and aluminum stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-103-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (81665-103-10) </PackageDescription>
    <NDC11Code>81665-0103-10</NDC11Code>
    <ProductNDC>81665-103</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
    <NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240502</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020215</ApplicationNumber>
    <LabelerName>OMNIVIUM PHARMACEUTICALS LLC.</LabelerName>
    <SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240502</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Isosorbide Mononitrate Tablets are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
    <Description>Isosorbide mononitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The empirical formula is C6H9NO6 and the molecular weight is 191.14. The chemical name for isosorbide mononitrate is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate and the compound has the following structural formula. Isosorbide Mononitrate Tablets, USP are available as 10 mg and 20 mg tablets. Each tablet also contains as inactive ingredients: lactose, talc, colloidal silicon dioxide, starch, microcrystalline cellulose and aluminum stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-107-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (81665-107-10) </PackageDescription>
    <NDC11Code>81665-0107-10</NDC11Code>
    <ProductNDC>81665-107</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isoniazid</ProprietaryName>
    <NonProprietaryName>Isoniazid</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241015</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040090</ApplicationNumber>
    <LabelerName>OMNIVIUM PHARMACEUTICALS LLC.</LabelerName>
    <SubstanceName>ISONIAZID</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimycobacterial [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241015</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Isoniazid is recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid, or any other medication is inadequate therapy. Isoniazid is recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parentheses). 1. Persons with human immunodeficiency virus (HIV) infection (≥ 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. Candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy. 2. Close contacts of persons with newly diagnosed infectious tuberculosis (≥ 5 mm). In addition, tuberculin-negative (&lt; 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (&gt; 5 mm), therapy should be continued. 3. Recent converters, as indicated by a tuberculin skin test (≥ 10 mm increase within a 2-year period for those &lt; 35 years old; ≥ 15 mm increase for those ≥ 35 years of age). All infants and children younger than 4 years of age with a &gt; 10 mm skin test are included in this category. 4. Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (≥ 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. 5. Intravenous drug users known to be HIV-seronegative (&gt; 10 mm). 6. Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (≥ 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin's disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state (with or without weight loss), chronic peptic ulcer disease, chronic malabsorption syndromes, and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. Additionally, in the absence of any of the above risk factors, persons under the age of 35 with a tuberculin skin test reaction of 10 mm or more are also appropriate candidates for preventive therapy if they are a member of any of the following high-incidence groups. 1. Foreign-born persons from high-prevalence countries who never received BCG vaccine. 2. Medically underserved low-income populations, including high-risk racial or ethnic minority populations, especially blacks, Hispanics, and Native Americans. 3. Residents of facilities for long-term care (e.g., correctional institutions, nursing homes, and mental institutions). Children who are less than 4 years old are candidates for isoniazid preventive therapy if they have &gt; 10 mm induration from a PPD Mantoux tuberculin skin test. Finally, persons under the age of 35 who a) have none of the above risk factors (1-6); b) belong to none of the high-incidence groups; and c) have a tuberculin skin test reaction of 15 mm or more, are appropriate candidates for preventive therapy. The risk of hepatitis must be weighed against the risk of tuberculosis in positive tuberculin reactions over the age of 35. However, the use of isoniazid is recommended for those with the additional risk factors listed above (1-6) and on an individual basis in situations where there is likelihood of serious consequences to contacts who may become infected.</IndicationAndUsage>
    <Description>Isoniazid is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose and stearic acid. Isoniazid is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has an empirical formula of C 6H 7N 3O and a molecular weight of 137.14. It has the following structure:. Isoniazid is odorless and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol, and slightly soluble in chloroform and in ether. Isoniazid is slowly affected by exposure to air and light.</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-108-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (81665-108-10) </PackageDescription>
    <NDC11Code>81665-0108-10</NDC11Code>
    <ProductNDC>81665-108</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isoniazid</ProprietaryName>
    <NonProprietaryName>Isoniazid</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241015</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040090</ApplicationNumber>
    <LabelerName>OMNIVIUM PHARMACEUTICALS LLC.</LabelerName>
    <SubstanceName>ISONIAZID</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimycobacterial [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241015</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Isoniazid is recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid, or any other medication is inadequate therapy. Isoniazid is recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parentheses). 1. Persons with human immunodeficiency virus (HIV) infection (≥ 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. Candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy. 2. Close contacts of persons with newly diagnosed infectious tuberculosis (≥ 5 mm). In addition, tuberculin-negative (&lt; 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (&gt; 5 mm), therapy should be continued. 3. Recent converters, as indicated by a tuberculin skin test (≥ 10 mm increase within a 2-year period for those &lt; 35 years old; ≥ 15 mm increase for those ≥ 35 years of age). All infants and children younger than 4 years of age with a &gt; 10 mm skin test are included in this category. 4. Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (≥ 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. 5. Intravenous drug users known to be HIV-seronegative (&gt; 10 mm). 6. Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (≥ 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin's disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state (with or without weight loss), chronic peptic ulcer disease, chronic malabsorption syndromes, and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. Additionally, in the absence of any of the above risk factors, persons under the age of 35 with a tuberculin skin test reaction of 10 mm or more are also appropriate candidates for preventive therapy if they are a member of any of the following high-incidence groups. 1. Foreign-born persons from high-prevalence countries who never received BCG vaccine. 2. Medically underserved low-income populations, including high-risk racial or ethnic minority populations, especially blacks, Hispanics, and Native Americans. 3. Residents of facilities for long-term care (e.g., correctional institutions, nursing homes, and mental institutions). Children who are less than 4 years old are candidates for isoniazid preventive therapy if they have &gt; 10 mm induration from a PPD Mantoux tuberculin skin test. Finally, persons under the age of 35 who a) have none of the above risk factors (1-6); b) belong to none of the high-incidence groups; and c) have a tuberculin skin test reaction of 15 mm or more, are appropriate candidates for preventive therapy. The risk of hepatitis must be weighed against the risk of tuberculosis in positive tuberculin reactions over the age of 35. However, the use of isoniazid is recommended for those with the additional risk factors listed above (1-6) and on an individual basis in situations where there is likelihood of serious consequences to contacts who may become infected.</IndicationAndUsage>
    <Description>Isoniazid is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose and stearic acid. Isoniazid is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has an empirical formula of C 6H 7N 3O and a molecular weight of 137.14. It has the following structure:. Isoniazid is odorless and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol, and slightly soluble in chloroform and in ether. Isoniazid is slowly affected by exposure to air and light.</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-108-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (81665-108-30) </PackageDescription>
    <NDC11Code>81665-0108-30</NDC11Code>
    <ProductNDC>81665-108</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isoniazid</ProprietaryName>
    <NonProprietaryName>Isoniazid</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241015</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040090</ApplicationNumber>
    <LabelerName>OMNIVIUM PHARMACEUTICALS LLC.</LabelerName>
    <SubstanceName>ISONIAZID</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimycobacterial [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241015</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Isoniazid is recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid, or any other medication is inadequate therapy. Isoniazid is recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parentheses). 1. Persons with human immunodeficiency virus (HIV) infection (≥ 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. Candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy. 2. Close contacts of persons with newly diagnosed infectious tuberculosis (≥ 5 mm). In addition, tuberculin-negative (&lt; 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (&gt; 5 mm), therapy should be continued. 3. Recent converters, as indicated by a tuberculin skin test (≥ 10 mm increase within a 2-year period for those &lt; 35 years old; ≥ 15 mm increase for those ≥ 35 years of age). All infants and children younger than 4 years of age with a &gt; 10 mm skin test are included in this category. 4. Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (≥ 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. 5. Intravenous drug users known to be HIV-seronegative (&gt; 10 mm). 6. Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (≥ 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin's disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state (with or without weight loss), chronic peptic ulcer disease, chronic malabsorption syndromes, and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. Additionally, in the absence of any of the above risk factors, persons under the age of 35 with a tuberculin skin test reaction of 10 mm or more are also appropriate candidates for preventive therapy if they are a member of any of the following high-incidence groups. 1. Foreign-born persons from high-prevalence countries who never received BCG vaccine. 2. Medically underserved low-income populations, including high-risk racial or ethnic minority populations, especially blacks, Hispanics, and Native Americans. 3. Residents of facilities for long-term care (e.g., correctional institutions, nursing homes, and mental institutions). Children who are less than 4 years old are candidates for isoniazid preventive therapy if they have &gt; 10 mm induration from a PPD Mantoux tuberculin skin test. Finally, persons under the age of 35 who a) have none of the above risk factors (1-6); b) belong to none of the high-incidence groups; and c) have a tuberculin skin test reaction of 15 mm or more, are appropriate candidates for preventive therapy. The risk of hepatitis must be weighed against the risk of tuberculosis in positive tuberculin reactions over the age of 35. However, the use of isoniazid is recommended for those with the additional risk factors listed above (1-6) and on an individual basis in situations where there is likelihood of serious consequences to contacts who may become infected.</IndicationAndUsage>
    <Description>Isoniazid is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose and stearic acid. Isoniazid is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has an empirical formula of C 6H 7N 3O and a molecular weight of 137.14. It has the following structure:. Isoniazid is odorless and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol, and slightly soluble in chloroform and in ether. Isoniazid is slowly affected by exposure to air and light.</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-108-51</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (81665-108-51) </PackageDescription>
    <NDC11Code>81665-0108-51</NDC11Code>
    <ProductNDC>81665-108</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isoniazid</ProprietaryName>
    <NonProprietaryName>Isoniazid</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241015</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040090</ApplicationNumber>
    <LabelerName>OMNIVIUM PHARMACEUTICALS LLC.</LabelerName>
    <SubstanceName>ISONIAZID</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimycobacterial [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241015</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Isoniazid is recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid, or any other medication is inadequate therapy. Isoniazid is recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parentheses). 1. Persons with human immunodeficiency virus (HIV) infection (≥ 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. Candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy. 2. Close contacts of persons with newly diagnosed infectious tuberculosis (≥ 5 mm). In addition, tuberculin-negative (&lt; 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (&gt; 5 mm), therapy should be continued. 3. Recent converters, as indicated by a tuberculin skin test (≥ 10 mm increase within a 2-year period for those &lt; 35 years old; ≥ 15 mm increase for those ≥ 35 years of age). All infants and children younger than 4 years of age with a &gt; 10 mm skin test are included in this category. 4. Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (≥ 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. 5. Intravenous drug users known to be HIV-seronegative (&gt; 10 mm). 6. Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (≥ 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin's disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state (with or without weight loss), chronic peptic ulcer disease, chronic malabsorption syndromes, and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. Additionally, in the absence of any of the above risk factors, persons under the age of 35 with a tuberculin skin test reaction of 10 mm or more are also appropriate candidates for preventive therapy if they are a member of any of the following high-incidence groups. 1. Foreign-born persons from high-prevalence countries who never received BCG vaccine. 2. Medically underserved low-income populations, including high-risk racial or ethnic minority populations, especially blacks, Hispanics, and Native Americans. 3. Residents of facilities for long-term care (e.g., correctional institutions, nursing homes, and mental institutions). Children who are less than 4 years old are candidates for isoniazid preventive therapy if they have &gt; 10 mm induration from a PPD Mantoux tuberculin skin test. Finally, persons under the age of 35 who a) have none of the above risk factors (1-6); b) belong to none of the high-incidence groups; and c) have a tuberculin skin test reaction of 15 mm or more, are appropriate candidates for preventive therapy. The risk of hepatitis must be weighed against the risk of tuberculosis in positive tuberculin reactions over the age of 35. However, the use of isoniazid is recommended for those with the additional risk factors listed above (1-6) and on an individual basis in situations where there is likelihood of serious consequences to contacts who may become infected.</IndicationAndUsage>
    <Description>Isoniazid is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose and stearic acid. Isoniazid is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has an empirical formula of C 6H 7N 3O and a molecular weight of 137.14. It has the following structure:. Isoniazid is odorless and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol, and slightly soluble in chloroform and in ether. Isoniazid is slowly affected by exposure to air and light.</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-109-10</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-109-10) </PackageDescription>
    <NDC11Code>81665-0109-10</NDC11Code>
    <ProductNDC>81665-109</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diethylpropion Hydrochloride</ProprietaryName>
    <ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
    <NonProprietaryName>Diethylpropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250919</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091680</ApplicationNumber>
    <LabelerName>OMNIVIUM PHARMACEUTICALS LLC.</LabelerName>
    <SubstanceName>DIETHYLPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-09-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250919</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diethylpropion hydrochloride extended release tablets, 75 mg are indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of BMI based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds divided by 2.2 = kg; inches x 0.0254 = meters. The usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below. Diethylpropion hydrochloride extended release tablets, 75 mg are indicated for use as monotherapy only.</IndicationAndUsage>
    <Description>Diethylpropion Hydrochloride Extended Release Tablets, 75 mg are available for oral administration as extended release tablets containing 75 mg diethylpropion hydrochloride, USP. The inactive ingredients in each extended release tablet are: mannitol, carbomer homopolymer, tartaric acid, hydroxypropyl methylcellulose, povidone, and magnesium stearate. Diethylpropion hydrochloride is a sympathomimetic agent. The chemical name for diethylpropion hydrochloride is 1-phenyl-2-diethyl-amino-1-propanone hydrochloride. Its chemical structure is. In diethylpropion hydrochloride extended release tablets, 75 mg, diethylpropion hydrochloride is dispersed in a hydrophilic matrix. On exposure to water, the diethylpropion hydrochloride is released at a relatively uniform rate as a result of slow hydration of the matrix. The result is controlled release of the anorectic agent.</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-109-25</NDCCode>
    <PackageDescription>250 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-109-25) </PackageDescription>
    <NDC11Code>81665-0109-25</NDC11Code>
    <ProductNDC>81665-109</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diethylpropion Hydrochloride</ProprietaryName>
    <ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
    <NonProprietaryName>Diethylpropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250919</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091680</ApplicationNumber>
    <LabelerName>OMNIVIUM PHARMACEUTICALS LLC.</LabelerName>
    <SubstanceName>DIETHYLPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-09-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250919</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diethylpropion hydrochloride extended release tablets, 75 mg are indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of BMI based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds divided by 2.2 = kg; inches x 0.0254 = meters. The usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below. Diethylpropion hydrochloride extended release tablets, 75 mg are indicated for use as monotherapy only.</IndicationAndUsage>
    <Description>Diethylpropion Hydrochloride Extended Release Tablets, 75 mg are available for oral administration as extended release tablets containing 75 mg diethylpropion hydrochloride, USP. The inactive ingredients in each extended release tablet are: mannitol, carbomer homopolymer, tartaric acid, hydroxypropyl methylcellulose, povidone, and magnesium stearate. Diethylpropion hydrochloride is a sympathomimetic agent. The chemical name for diethylpropion hydrochloride is 1-phenyl-2-diethyl-amino-1-propanone hydrochloride. Its chemical structure is. In diethylpropion hydrochloride extended release tablets, 75 mg, diethylpropion hydrochloride is dispersed in a hydrophilic matrix. On exposure to water, the diethylpropion hydrochloride is released at a relatively uniform rate as a result of slow hydration of the matrix. The result is controlled release of the anorectic agent.</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-200-05</NDCCode>
    <PackageDescription>20 VIAL in 1 CARTON (81665-200-05)  / 50 mL in 1 VIAL (81665-200-01) </PackageDescription>
    <NDC11Code>81665-0200-05</NDC11Code>
    <ProductNDC>81665-200</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Bicarbonate</ProprietaryName>
    <NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230616</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216364</ApplicationNumber>
    <LabelerName>OMNIVIUM PHARMACEUTICALS LLC.</LabelerName>
    <SubstanceName>SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>84</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Alkalinizing Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-08-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230616</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis - e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial - e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.</IndicationAndUsage>
    <Description>Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solution is offered in concentration of 8.4%. See table in HOW SUPPLIED section for contents and characteristics. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection, the approximate pH of the solution is 8. When smaller doses are required, the unused portion should be discarded. Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na+ and HCO3- . Sodium Bicarbonate, USP is chemically designated NaHCO3, a white crystalline powder soluble in water. Water for Injection, USP is chemically designated H2O.</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-200-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (81665-200-25)  / 50 mL in 1 VIAL (81665-200-01) </PackageDescription>
    <NDC11Code>81665-0200-25</NDC11Code>
    <ProductNDC>81665-200</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Bicarbonate</ProprietaryName>
    <NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230616</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216364</ApplicationNumber>
    <LabelerName>OMNIVIUM PHARMACEUTICALS LLC.</LabelerName>
    <SubstanceName>SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>84</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Alkalinizing Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-08-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230616</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis - e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial - e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.</IndicationAndUsage>
    <Description>Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solution is offered in concentration of 8.4%. See table in HOW SUPPLIED section for contents and characteristics. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection, the approximate pH of the solution is 8. When smaller doses are required, the unused portion should be discarded. Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na+ and HCO3- . Sodium Bicarbonate, USP is chemically designated NaHCO3, a white crystalline powder soluble in water. Water for Injection, USP is chemically designated H2O.</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-202-01</NDCCode>
    <PackageDescription>1 mL in 1 AMPULE (81665-202-01) </PackageDescription>
    <NDC11Code>81665-0202-01</NDC11Code>
    <ProductNDC>81665-202</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carboprost Tromethamine</ProprietaryName>
    <NonProprietaryName>Carboprost Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20250515</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213118</ApplicationNumber>
    <LabelerName>Omnivium Pharmaceuticals LLC</LabelerName>
    <SubstanceName>CARBOPROST TROMETHAMINE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carboprost tromethamine, USP is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: 1 Failure of expulsion of the fetus during the course of treatment by another method;, 2 Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity;, 3 Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus;, 4 Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion.</IndicationAndUsage>
    <Description>Carboprost Tromethamine Injection, USP an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine is the established name for the active ingredient in Carboprost Tromethamine Injection, USP. Four other chemical names are: 1 (15S)-15-methyl prostaglandin F2α tromethamine salt, 2 7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl- trans-1-octenyl]-1α-cyclopentyl]- cis-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol , 3 (15S)-9α,11α,15-trihydroxy-15-methylprosta- cis-5, trans-13-dienoic acid tromethamine salt , 4 (15S)-15-methyl PGF2α-THAM.</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-202-10</NDCCode>
    <PackageDescription>10 AMPULE in 1 CARTON (81665-202-10)  / 1 mL in 1 AMPULE (81665-202-01) </PackageDescription>
    <NDC11Code>81665-0202-10</NDC11Code>
    <ProductNDC>81665-202</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carboprost Tromethamine</ProprietaryName>
    <NonProprietaryName>Carboprost Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20250515</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213118</ApplicationNumber>
    <LabelerName>Omnivium Pharmaceuticals LLC</LabelerName>
    <SubstanceName>CARBOPROST TROMETHAMINE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carboprost tromethamine, USP is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: 1 Failure of expulsion of the fetus during the course of treatment by another method;, 2 Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity;, 3 Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus;, 4 Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion.</IndicationAndUsage>
    <Description>Carboprost Tromethamine Injection, USP an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine is the established name for the active ingredient in Carboprost Tromethamine Injection, USP. Four other chemical names are: 1 (15S)-15-methyl prostaglandin F2α tromethamine salt, 2 7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl- trans-1-octenyl]-1α-cyclopentyl]- cis-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol , 3 (15S)-9α,11α,15-trihydroxy-15-methylprosta- cis-5, trans-13-dienoic acid tromethamine salt , 4 (15S)-15-methyl PGF2α-THAM.</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-203-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (81665-203-01)  / 50 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>81665-0203-01</NDC11Code>
    <ProductNDC>81665-203</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Phenylacetate And Sodium Benzoate</ProprietaryName>
    <NonProprietaryName>Sodium Phenylacetate And Sodium Benzoate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250225</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207096</ApplicationNumber>
    <LabelerName>Omnivium Pharmaceuticals LLC</LabelerName>
    <SubstanceName>SODIUM PHENYLACETATE; SODIUM BENZOATE</SubstanceName>
    <StrengthNumber>100; 100</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Ammonium Ion Binding Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Nitrogen Binding Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250225</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. During acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [see Warnings and Precautions (5)].</IndicationAndUsage>
    <Description>Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% (a nitrogen binding agent), is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate. The pH of the solution is between 6 and 8. Sodium phenylacetate is a crystalline, white to off-white powder with a strong, offensive odor. It is soluble in water. Sodium benzoate is a white and odorless, crystalline powder that is readily soluble in water. Figure 1. Sodium phenylacetate has a molecular weight of 158.13 and the molecular formula C8H7NaO2. Sodium benzoate has a molecular weight of 144.11 and the molecular formula C7H5NaO2. Each mL of Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% contains 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, and Water for Injection. Sodium hydroxide and/or hydrochloric acid may have been used for pH adjustment. Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% injection is a sterile, concentrated solution intended for intravenous administration via a central line only after dilution [see Dosage and Administration (2)].</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-204-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (81665-204-01)  / 50 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>81665-0204-01</NDC11Code>
    <ProductNDC>81665-204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Phenylacetate And Sodium Benzoate</ProprietaryName>
    <NonProprietaryName>Sodium Phenylacetate And Sodium Benzoate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250515</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207096</ApplicationNumber>
    <LabelerName>Omnivium Pharmaceuticals LLC</LabelerName>
    <SubstanceName>SODIUM PHENYLACETATE; SODIUM BENZOATE</SubstanceName>
    <StrengthNumber>100; 100</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Ammonium Ion Binding Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Nitrogen Binding Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. During acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [see Warnings and Precautions (5)].</IndicationAndUsage>
    <Description>Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% (a nitrogen binding agent), is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate. The pH of the solution is between 6 and 8. Sodium phenylacetate is a crystalline, white to off-white powder with a strong, offensive odor. It is soluble in water. Sodium benzoate is a white and odorless, crystalline powder that is readily soluble in water. Figure 1. Sodium phenylacetate has a molecular weight of 158.13 and the molecular formula C8H7NaO2. Sodium benzoate has a molecular weight of 144.11 and the molecular formula C7H5NaO2. Each mL of Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% contains 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, and Water for Injection. Sodium hydroxide and/or hydrochloric acid may have been used for pH adjustment. Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% injection is a sterile, concentrated solution intended for intravenous administration via a central line only after dilution [see Dosage and Administration (2)].</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-300-02</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (81665-300-02)  / 4 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>81665-0300-02</NDC11Code>
    <ProductNDC>81665-300</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Numbrino</ProprietaryName>
    <NonProprietaryName>Cocaine Hydrochloride Nasal</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240619</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209575</ApplicationNumber>
    <LabelerName>OMNIVIUM PHARMACEUTICALS LLC.</LabelerName>
    <SubstanceName>COCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240619</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NUMBRINO (cocaine hydrochloride) nasal solution is indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults.</IndicationAndUsage>
    <Description>NUMBRINOTM (cocaine hydrochloride) nasal solution is a clear, blue-green, aqueous solution, available in 4% strength. Each 1 mL contains cocaine hydrochloride 40 mg, equivalent to 35.7 mg of cocaine free base; 4% as 160 mg/4 mL or 400 mg/10 mL. Cocaine, (1R,2R,3S,5S) methyl 3-(benzoyloxy)-8-methyl-8-azabicyclo[3.2.1]octane-2-carboxylate hydrochloride, is a synthetic tropane alkaloid ester, local anesthetic, which occurs as colorless to white crystals or white crystalline powder. The structural formula for cocaine hydrochloride is as follows. Formula C17H21NO4 HCl     Molecular weight 339.81. NUMBRINO also contains the following inactive ingredients: purified water, citric acid (anhydrous), sodium benzoate, D&amp;C Yellow No. 10, and FD&amp;C Green No. 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>81665-301-02</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (81665-301-02)  / 4 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>81665-0301-02</NDC11Code>
    <ProductNDC>81665-301</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cocaine Hydrochloride Nasal</ProprietaryName>
    <NonProprietaryName>Cocaine Hydrochloride Nasal</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20231015</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA209575</ApplicationNumber>
    <LabelerName>OMNIVIUM PHARMACEUTICALS LLC.</LabelerName>
    <SubstanceName>COCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2023-10-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231015</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cocaine Hydrochloride nasal solution is indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults.</IndicationAndUsage>
    <Description>Cocaine Hydrochloride nasal solution is a clear, blue-green, aqueous solution, available in 4% strength. Each 1 mL contains cocaine hydrochloride 40 mg, equivalent to 35.7 mg of cocaine free base; 4% as 160 mg/4 mL or 400 mg/10 mL. Cocaine, (1R,2R,3S,5S) methyl 3-(benzoyloxy)-8-methyl-8-azabicyclo[3.2.1]octane-2-carboxylate hydrochloride, is a synthetic tropane alkaloid ester, local anesthetic, which occurs as colorless to white crystals or white crystalline powder. The structural formula for cocaine hydrochloride is as follows. Formula C17H21NO4 HCl     Molecular weight 339.81. Cocaine hydrochloride also contains the following inactive ingredients: purified water, citric acid (anhydrous), sodium benzoate, D&amp;C Yellow No. 10, and FD&amp;C Green No. 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>0009-4709-13</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (0009-4709-13)  / .65 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00009-4709-13</NDC11Code>
    <ProductNDC>0009-4709</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Depo-subq Provera</ProprietaryName>
    <NonProprietaryName>Medroxyprogesterone Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20050502</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021583</ApplicationNumber>
    <LabelerName>Pharmacia &amp; Upjohn Company LLC</LabelerName>
    <SubstanceName>MEDROXYPROGESTERONE ACETATE</SubstanceName>
    <StrengthNumber>104</StrengthNumber>
    <StrengthUnit>mg/.65mL</StrengthUnit>
    <Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20050502</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Depo-subQ provera 104 is indicated in females of reproductive age for: 1 Prevention of pregnancy and, 2 Management of endometriosis-associated pain.</IndicationAndUsage>
    <Description>Depo-subQ provera 104 contains medroxyprogesterone acetate (MPA), a derivative of progesterone, as its active ingredient. MPA is a white to off-white, odorless crystalline powder that is stable in air and that melts between 205°C and 209°C. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water. The chemical name for MPA is 17-hydroxy-6α-methylpregn-4-ene-3,20-dione 17-acetate. The structural formula is as follows. Depo-subQ provera 104 for subcutaneous use is available in pre-filled syringes, each containing 0.65 mL (104 mg) of sterile medroxyprogesterone acetate injectable suspension. Each 0.65 mL contains the following inactive ingredients. When necessary, the pH is adjusted with sodium hydroxide or hydrochloric acid, or both.</Description>
  </NDC>
</NDCList>