RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>63548-0264-7</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (63548-0264-7)  / 27 LOZENGE in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>63548-0264-07</NDC11Code>
    <ProductNDC>63548-0264</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nicotine</ProprietaryName>
    <ProprietaryNameSuffix>Mini</ProprietaryNameSuffix>
    <NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207868</ApplicationNumber>
    <LabelerName>PLD Acquisitions LLC DBA Av�ma Pharma Solutions</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63548-0262-7</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (63548-0262-7)  / 27 LOZENGE in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>63548-0262-07</NDC11Code>
    <ProductNDC>63548-0262</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nicotine</ProprietaryName>
    <ProprietaryNameSuffix>Mini</ProprietaryNameSuffix>
    <NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207868</ApplicationNumber>
    <LabelerName>PLD Acquisitions LLC DBA Av�ma Pharma Solutions</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63548-0264-0</NDCCode>
    <PackageDescription>4 BOTTLE, PLASTIC in 1 BOX (63548-0264-0)  / 27 LOZENGE in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>63548-0264-00</NDC11Code>
    <ProductNDC>63548-0264</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nicotine</ProprietaryName>
    <ProprietaryNameSuffix>Mini</ProprietaryNameSuffix>
    <NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207868</ApplicationNumber>
    <LabelerName>PLD Acquisitions LLC DBA Av�ma Pharma Solutions</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63548-0264-1</NDCCode>
    <PackageDescription>3 BOTTLE, PLASTIC in 1 BOX (63548-0264-1)  / 27 LOZENGE in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>63548-0264-01</NDC11Code>
    <ProductNDC>63548-0264</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nicotine</ProprietaryName>
    <ProprietaryNameSuffix>Mini</ProprietaryNameSuffix>
    <NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207868</ApplicationNumber>
    <LabelerName>PLD Acquisitions LLC DBA Av�ma Pharma Solutions</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>56152-0264-1</NDCCode>
    <PackageDescription>7.1 g in 1 TUBE (56152-0264-1) </PackageDescription>
    <NDC11Code>56152-0264-01</NDC11Code>
    <ProductNDC>56152-0264</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Impeccable Skin Sunscreen Foundation Broad Spectrum Spf 30 Mocha</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241024</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Cosmetic Enterprises Ltd</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241024</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>56152-0264-2</NDCCode>
    <PackageDescription>56.7 g in 1 TUBE (56152-0264-2) </PackageDescription>
    <NDC11Code>56152-0264-02</NDC11Code>
    <ProductNDC>56152-0264</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Impeccable Skin Sunscreen Foundation Broad Spectrum Spf 30 Mocha</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241024</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Cosmetic Enterprises Ltd</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241024</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0264-1009-90</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-1009-90)  / 100 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-1009-90</NDC11Code>
    <ProductNDC>0264-1009</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240513</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209705</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (greater than or equal to 16 years of age) with the following seizure types when oral administration is temporarily not feasible: 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures (1.3).</IndicationAndUsage>
    <Description>Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous 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 in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port container. This container closure is not made with natural rubber latex, PVC or DEHP. 500 mg/100 mL: One 100 mL fill container contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL fill container contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL fill container contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition. Each is covered by a tamperproof barrier. Refer to the DIRECTIONS FOR USE of the container to properly identify the ports. No vapor barrier is necessary.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-1509-90</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-1509-90)  / 100 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-1509-90</NDC11Code>
    <ProductNDC>0264-1509</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240513</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209705</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (greater than or equal to 16 years of age) with the following seizure types when oral administration is temporarily not feasible: 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures (1.3).</IndicationAndUsage>
    <Description>Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous 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 in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port container. This container closure is not made with natural rubber latex, PVC or DEHP. 500 mg/100 mL: One 100 mL fill container contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL fill container contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL fill container contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition. Each is covered by a tamperproof barrier. Refer to the DIRECTIONS FOR USE of the container to properly identify the ports. No vapor barrier is necessary.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-1800-31</NDCCode>
    <PackageDescription>84 CONTAINER in 1 CASE (0264-1800-31)  &gt; 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-1800-31</NDC11Code>
    <ProductNDC>0264-1800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19780208</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017464</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19780208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. Consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner.</IndicationAndUsage>
    <Description>Each mL of 0.9% Sodium Chloride Injection USP contains. Sodium Chloride USP 9 mg; Water for Injection USP qspH adjusted with Hydrochloric Acid NFpH: 5.5 (4.5–7.0)Calculated Osmolarity: 310 mOsmol/literConcentration of Electrolytes (mEq/100 mL): Sodium 15.4 Chloride 15.4. This solution is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition site. Each is covered by a tamperproof barrier. Refer to the Directions for Use  of the container to properly identify the ports. No vapor barrier is necessary.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-1800-32</NDCCode>
    <PackageDescription>64 CONTAINER in 1 CASE (0264-1800-32)  &gt; 100 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-1800-32</NDC11Code>
    <ProductNDC>0264-1800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19780208</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017464</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19780208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. Consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner.</IndicationAndUsage>
    <Description>Each mL of 0.9% Sodium Chloride Injection USP contains. Sodium Chloride USP 9 mg; Water for Injection USP qspH adjusted with Hydrochloric Acid NFpH: 5.5 (4.5–7.0)Calculated Osmolarity: 310 mOsmol/literConcentration of Electrolytes (mEq/100 mL): Sodium 15.4 Chloride 15.4. This solution is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition site. Each is covered by a tamperproof barrier. Refer to the Directions for Use  of the container to properly identify the ports. No vapor barrier is necessary.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-1800-36</NDCCode>
    <PackageDescription>116 CONTAINER in 1 CASE (0264-1800-36)  &gt; 25 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-1800-36</NDC11Code>
    <ProductNDC>0264-1800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19780208</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017464</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19780208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. Consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner.</IndicationAndUsage>
    <Description>Each mL of 0.9% Sodium Chloride Injection USP contains. Sodium Chloride USP 9 mg; Water for Injection USP qspH adjusted with Hydrochloric Acid NFpH: 5.5 (4.5–7.0)Calculated Osmolarity: 310 mOsmol/literConcentration of Electrolytes (mEq/100 mL): Sodium 15.4 Chloride 15.4. This solution is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition site. Each is covered by a tamperproof barrier. Refer to the Directions for Use  of the container to properly identify the ports. No vapor barrier is necessary.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-1945-10</NDCCode>
    <PackageDescription>500 mL in 1 BAG (0264-1945-10) </PackageDescription>
    <NDC11Code>00264-1945-10</NDC11Code>
    <ProductNDC>0264-1945</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Balanced Salt</ProprietaryName>
    <NonProprietaryName>Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, And Sodium Citrate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>20220128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091387</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE</SubstanceName>
    <StrengthNumber>6.4; .75; .48; .3; 3.9; 1.7</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.</IndicationAndUsage>
    <Description>Balanced Salt Solution Sterile Irrigating Solution is a sterile balanced salt solution in 500 mL single-dose EXCEL® flexible containers. Each mL contains sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl2·2H2O) 0.048%, magnesium chloride hexahydrate (MgCl2·6H2O) 0.03%, sodium acetate trihydrate (C2H3NaO2·3H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O7·2H2O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.0. The osmolality is approximately 300 mOsm/Kg. The EXCEL® plastic container is made from a multilayered film. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-2101-00</NDCCode>
    <PackageDescription>16 CONTAINER in 1 CASE (0264-2101-00)  / 1000 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-2101-00</NDC11Code>
    <ProductNDC>0264-2101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sterile Water</ProprietaryName>
    <NonProprietaryName>Water</NonProprietaryName>
    <DosageFormName>IRRIGANT</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>19700910</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA016734</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>WATER</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19700910</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sterile Water for Irrigation USP is indicated for use as an irrigating fluid or pharmaceutic aid. Sterile Water may also be used as an adjunct in the preparation of non-intravenously administered nutrient mixtures (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
    <Description>Sterile Water for Irrigation USP is a sterile, hypotonic, nonpyrogenic irrigating fluid or pharmaceutic aid (solvent) entirely composed of Sterile Water for Injection USP. It is prepared by distillation and contains no antimicrobial or bacteriostatic agents or added buffers. The pH is 5.7 (5.0–7.0). The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. Not made with natural rubber Latex, PVC or DEHP. Bottle may exhibit some discoloration upon storage which does not impact product quality.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-2101-10</NDCCode>
    <PackageDescription>16 CONTAINER in 1 CASE (0264-2101-10)  / 500 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-2101-10</NDC11Code>
    <ProductNDC>0264-2101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sterile Water</ProprietaryName>
    <NonProprietaryName>Water</NonProprietaryName>
    <DosageFormName>IRRIGANT</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>19700910</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA016734</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>WATER</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19700910</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sterile Water for Irrigation USP is indicated for use as an irrigating fluid or pharmaceutic aid. Sterile Water may also be used as an adjunct in the preparation of non-intravenously administered nutrient mixtures (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
    <Description>Sterile Water for Irrigation USP is a sterile, hypotonic, nonpyrogenic irrigating fluid or pharmaceutic aid (solvent) entirely composed of Sterile Water for Injection USP. It is prepared by distillation and contains no antimicrobial or bacteriostatic agents or added buffers. The pH is 5.7 (5.0–7.0). The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. Not made with natural rubber Latex, PVC or DEHP. Bottle may exhibit some discoloration upon storage which does not impact product quality.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-2201-00</NDCCode>
    <PackageDescription>16 CONTAINER in 1 CASE (0264-2201-00)  / 1000 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-2201-00</NDC11Code>
    <ProductNDC>0264-2201</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>IRRIGANT</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>20090914</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA016733</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.9</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090914</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.</IndicationAndUsage>
    <Description>Each 100 mL contains: Sodium Chloride USP 0.9 g; Water for Injection USP qs. pH adjusted with Hydrochloric Acid NF pH: 5.0 (4.5–7.0)      Calculated Osmolarity: 310 mOsmol/liter. Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154. 0.9% Sodium Chloride Irrigation USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. Not made with natural rubber latex, PVC or DEHP. Bottle may exhibit some discoloration upon storage which does not impact product quality.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-2201-10</NDCCode>
    <PackageDescription>16 CONTAINER in 1 CASE (0264-2201-10)  / 500 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-2201-10</NDC11Code>
    <ProductNDC>0264-2201</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>IRRIGANT</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>20090914</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA016733</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.9</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090914</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.</IndicationAndUsage>
    <Description>Each 100 mL contains: Sodium Chloride USP 0.9 g; Water for Injection USP qs. pH adjusted with Hydrochloric Acid NF pH: 5.0 (4.5–7.0)      Calculated Osmolarity: 310 mOsmol/liter. Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154. 0.9% Sodium Chloride Irrigation USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. Not made with natural rubber latex, PVC or DEHP. Bottle may exhibit some discoloration upon storage which does not impact product quality.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-2202-00</NDCCode>
    <PackageDescription>16 CONTAINER in 1 CASE (0264-2202-00)  / 1000 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-2202-00</NDC11Code>
    <ProductNDC>0264-2202</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ringers</ProprietaryName>
    <NonProprietaryName>Sodium Chloride, Potassium Chloride, And Calcium Chloride</NonProprietaryName>
    <DosageFormName>IRRIGANT</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>19790806</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018156</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.86; .03; .033</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19790806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ringer’s Irrigation USP is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.</IndicationAndUsage>
    <Description>Ringer’s Irrigation USP is a sterile, nonpyrogenic, solution of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes. Each 100 mL contains. Sodium Chloride USP 0.86 g; Potassium Chloride USP 0.03 g Calcium Chloride Dihydrate USP 0.033 g; Water for Injection USP qs. pH: 5.8 (5.0-7.5). The solution is isotonic (310 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Na+ 147; K+ 4 Ca++ 4.5; Cl− 156. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Ringer’s Irrigation USP may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. The formulas of the active ingredients are. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. Not made with natural rubber latex, PVC or DEHP.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-2203-00</NDCCode>
    <PackageDescription>16 CONTAINER in 1 CASE (0264-2203-00)  / 1000 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-2203-00</NDC11Code>
    <ProductNDC>0264-2203</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lactated Ringers</ProprietaryName>
    <NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride</NonProprietaryName>
    <DosageFormName>IRRIGANT</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>19821227</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018681</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.6; .31; .03; .02</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19821227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lactated Ringer's Irrigation is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.</IndicationAndUsage>
    <Description>Lactated Ringer's Irrigation is a sterile, nonpyrogenic, solution of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes. The composition is based on a modification of the injectable formula originally known as Hartmann's Solution. Each 100 mL contains: Sodium Chloride USP 0.6 g, Sodium Lactate 0.31 g, Potassium Chloride USP 0.03 g, Calcium Chloride Dihydrate USP 0.02 g, Water for Injection USP qs. pH adjusted with Hydrochloric Acid NF pH: 6.75 (6.0–7.5)           Calculated Osmolarity: 275 mOsmol/liter. Concentration of Electrolytes (mEq/liter): Sodium 130, Potassium 4, Calcium 3, Chloride 110, Lactate (CH3CH(OH)COO−) 28. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required the unused portions should be discarded. Lactated Ringer's Irrigation may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. The formulas of the active ingredients are. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. Not made with natural rubber latex, PVC or DEHP.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-2205-00</NDCCode>
    <PackageDescription>16 CONTAINER in 1 CASE (0264-2205-00)  / 1000 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-2205-00</NDC11Code>
    <ProductNDC>0264-2205</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Physiolyte</ProprietaryName>
    <NonProprietaryName>Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, And Magnesium Chloride</NonProprietaryName>
    <DosageFormName>IRRIGANT</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>19840608</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019024</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.53; .5; .37; .037; .03</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19840608</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Physiolyte (A Physiological Irrigating Solution) is indicated for all general irrigation, washing, and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.</IndicationAndUsage>
    <Description>Physiolyte is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing, and rinsing purposes. Each 100 mL contains:Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 gSodium Acetate Trihydrate USP 0.37 g; Potassium ChlorideUSP 0.037 g; Magnesium Chloride Hexahydrate USP 0.03 gWater for Injection USP qsGlacial Acetic Acid USP has been added to adjust the pH. pH: 6.8 (6.3–7.3)Calculated Osmolarity: The solution is isotonic (295 mOsmol/liter). Concentration of Electrolytes (mEq/liter): Sodium 140Potassium 5; Magnesium 3; Chloride 98; Acetate (CH3COO−) 27Gluconate (HOCH2(CHOH)4COO−) 23. It contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Physiolyte may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. The formulas of the active ingredients are. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. Not made with natural rubber latex, PVC or DEHP.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-2514-10</NDCCode>
    <PackageDescription>500 mL in 1 BOTTLE, GLASS (0264-2514-10) </PackageDescription>
    <NDC11Code>00264-2514-10</NDC11Code>
    <ProductNDC>0264-2514</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Balanced Salt</ProprietaryName>
    <NonProprietaryName>Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, And Sodium Citrate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>20100203</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091387</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE</SubstanceName>
    <StrengthNumber>.48; .3; .75; 3.9; 6.4; 1.7</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.</IndicationAndUsage>
    <Description>Balanced Salt Solution Sterile Irrigating Solution is a sterile balanced salt solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl2·2H2O) 0.048%, magnesium chloride hexahydrate (MgCl2·6H2O) 0.03%, sodium acetate trihydrate (C2H3NaO2·3H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O7·2H2O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.0. The osmolality is approximately 300 mOsm/Kg.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-3103-11</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-3103-11)  / 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-3103-11</NDC11Code>
    <ProductNDC>0264-3103</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefazolin Sodium</ProprietaryName>
    <NonProprietaryName>Cefazolin Sodium</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20000727</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050779</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>CEFAZOLIN SODIUM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20000727</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefazolin for Injection and Dextrose Injection is a cephalosporin antibacterial indicated for: : 1 Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: (1).</IndicationAndUsage>
    <Description>Cefazolin for Injection USP and Dextrose Injection USP is a sterile, nonpyrogenic, single-dose, packaged combination of Cefazolin Sodium USP (lyophilized) and sterile iso-osmotic diluent in the DUPLEX® sterile container. The DUPLEX® Container is a flexible dual chamber container. After reconstitution the approximate osmolality for Cefazolin for Injection USP and Dextrose Injection USP is 290 mOsmol/kg. The drug chamber is filled with sterile lyophilized Cefazolin Sodium USP, a semi-synthetic cephalosporin and has the following IUPAC nomenclature: Sodium (6R,7R)-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[2-(1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate. Its empirical formula is C14H13N8NaO4S3 and its molecular weight is 476.48. Cefazolin Sodium USP has the following structural formula. The sodium content is 48 mg/g of cefazolin sodium. The diluent chamber contains Dextrose Injection USP, an iso-osmotic diluent using Hydrous Dextrose USP in Water for Injection USP. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents.  Its empirical formula is C6H12O6H2O and its molecular weight is 198.17. Hydrous Dextrose USP has the following structural (molecular) formula. Cefazolin Sodium USP is supplied as a lyophilized form equivalent to either 1 gram, 2 grams or 3 grams of cefazolin. The 1 gram / container Cefazolin Sodium USP contains 1 gram of cefazolin (equivalent to 1.048 grams of cefazolin sodium). The 2 grams / container Cefazolin Sodium USP contains 2 grams of cefazolin (equivalent to 2.096 grams of cefazolin sodium). The 3 grams / container Cefazolin Sodium USP contains 3 grams of cefazolin (equivalent to 3.145 grams of cefazolin sodium). Dextrose Hydrous USP has been added to the diluent (Water for Injection USP) to adjust osmolality (approximately 2 grams [4% w/v], 1.5 grams [3% w/v] and 1 gram [2% w/v] for the 1 gram, 2 gram or 3 gram dosages, respectively). After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. The pH of reconstituted solutions of Cefazolin for Injection and Dextrose Injection is 3.5 to 7.0. Reconstituted solutions of Cefazolin for Injection and Dextrose Injection range in color from pale yellow to amber. Not made with natural rubber latex, PVC or DEHP. The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-3105-11</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-3105-11)  / 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-3105-11</NDC11Code>
    <ProductNDC>0264-3105</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefazolin Sodium</ProprietaryName>
    <NonProprietaryName>Cefazolin Sodium</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20120113</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050779</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>CEFAZOLIN SODIUM</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefazolin for Injection and Dextrose Injection is a cephalosporin antibacterial indicated for: : 1 Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: (1).</IndicationAndUsage>
    <Description>Cefazolin for Injection USP and Dextrose Injection USP is a sterile, nonpyrogenic, single-dose, packaged combination of Cefazolin Sodium USP (lyophilized) and sterile iso-osmotic diluent in the DUPLEX® sterile container. The DUPLEX® Container is a flexible dual chamber container. After reconstitution the approximate osmolality for Cefazolin for Injection USP and Dextrose Injection USP is 290 mOsmol/kg. The drug chamber is filled with sterile lyophilized Cefazolin Sodium USP, a semi-synthetic cephalosporin and has the following IUPAC nomenclature: Sodium (6R,7R)-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[2-(1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate. Its empirical formula is C14H13N8NaO4S3 and its molecular weight is 476.48. Cefazolin Sodium USP has the following structural formula. The sodium content is 48 mg/g of cefazolin sodium. The diluent chamber contains Dextrose Injection USP, an iso-osmotic diluent using Hydrous Dextrose USP in Water for Injection USP. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents.  Its empirical formula is C6H12O6H2O and its molecular weight is 198.17. Hydrous Dextrose USP has the following structural (molecular) formula. Cefazolin Sodium USP is supplied as a lyophilized form equivalent to either 1 gram, 2 grams or 3 grams of cefazolin. The 1 gram / container Cefazolin Sodium USP contains 1 gram of cefazolin (equivalent to 1.048 grams of cefazolin sodium). The 2 grams / container Cefazolin Sodium USP contains 2 grams of cefazolin (equivalent to 2.096 grams of cefazolin sodium). The 3 grams / container Cefazolin Sodium USP contains 3 grams of cefazolin (equivalent to 3.145 grams of cefazolin sodium). Dextrose Hydrous USP has been added to the diluent (Water for Injection USP) to adjust osmolality (approximately 2 grams [4% w/v], 1.5 grams [3% w/v] and 1 gram [2% w/v] for the 1 gram, 2 gram or 3 gram dosages, respectively). After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. The pH of reconstituted solutions of Cefazolin for Injection and Dextrose Injection is 3.5 to 7.0. Reconstituted solutions of Cefazolin for Injection and Dextrose Injection range in color from pale yellow to amber. Not made with natural rubber latex, PVC or DEHP. The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-3107-11</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-3107-11)  / 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-3107-11</NDC11Code>
    <ProductNDC>0264-3107</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefazolin Sodium</ProprietaryName>
    <NonProprietaryName>Cefazolin Sodium</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250310</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050779</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>CEFAZOLIN SODIUM</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250310</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefazolin for Injection and Dextrose Injection is a cephalosporin antibacterial indicated for: : 1 Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: (1).</IndicationAndUsage>
    <Description>Cefazolin for Injection USP and Dextrose Injection USP is a sterile, nonpyrogenic, single-dose, packaged combination of Cefazolin Sodium USP (lyophilized) and sterile iso-osmotic diluent in the DUPLEX® sterile container. The DUPLEX® Container is a flexible dual chamber container. After reconstitution the approximate osmolality for Cefazolin for Injection USP and Dextrose Injection USP is 290 mOsmol/kg. The drug chamber is filled with sterile lyophilized Cefazolin Sodium USP, a semi-synthetic cephalosporin and has the following IUPAC nomenclature: Sodium (6R,7R)-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[2-(1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate. Its empirical formula is C14H13N8NaO4S3 and its molecular weight is 476.48. Cefazolin Sodium USP has the following structural formula. The sodium content is 48 mg/g of cefazolin sodium. The diluent chamber contains Dextrose Injection USP, an iso-osmotic diluent using Hydrous Dextrose USP in Water for Injection USP. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents.  Its empirical formula is C6H12O6H2O and its molecular weight is 198.17. Hydrous Dextrose USP has the following structural (molecular) formula. Cefazolin Sodium USP is supplied as a lyophilized form equivalent to either 1 gram, 2 grams or 3 grams of cefazolin. The 1 gram / container Cefazolin Sodium USP contains 1 gram of cefazolin (equivalent to 1.048 grams of cefazolin sodium). The 2 grams / container Cefazolin Sodium USP contains 2 grams of cefazolin (equivalent to 2.096 grams of cefazolin sodium). The 3 grams / container Cefazolin Sodium USP contains 3 grams of cefazolin (equivalent to 3.145 grams of cefazolin sodium). Dextrose Hydrous USP has been added to the diluent (Water for Injection USP) to adjust osmolality (approximately 2 grams [4% w/v], 1.5 grams [3% w/v] and 1 gram [2% w/v] for the 1 gram, 2 gram or 3 gram dosages, respectively). After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. The pH of reconstituted solutions of Cefazolin for Injection and Dextrose Injection is 3.5 to 7.0. Reconstituted solutions of Cefazolin for Injection and Dextrose Injection range in color from pale yellow to amber. Not made with natural rubber latex, PVC or DEHP. The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-3112-11</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-3112-11)  &gt; 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-3112-11</NDC11Code>
    <ProductNDC>0264-3112</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefuroxime And Dextrose</ProprietaryName>
    <NonProprietaryName>Cefuroxime And Dextrose</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20010221</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050780</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>CEFUROXIME SODIUM</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/50mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-12-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20010221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefuroxime for Injection USP and Dextrose Injection USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: 1 Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, and Escherichia coli. , 2 Urinary Tract Infections caused by Escherichia coli and Klebsiella spp. , 3 Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp. , 4 Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp. , 5 Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains). , 6 Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females. , 7 Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase producing strains).</IndicationAndUsage>
    <Description>Cefuroxime for Injection USP and Dextrose Injection USP is a sterile, nonpyrogenic, single use, packaged combination of Cefuroxime Sodium USP (crystalline) and Dextrose Injection USP (diluent) in the DUPLEX® sterile container. The DUPLEX® Container is a flexible dual chamber container. The drug chamber is filled with sterile crystalline Cefuroxime for Injection USP, a semi-synthetic, broad-spectrum, cephalosporin antibacterial for parenteral administration. It is the sodium salt of (6R,7R)-7-[2-(2-furyl)glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate, 72-(Z)-(O-methyloxime), carbamate (ester). Cefuroxime Sodium USP has the following structural formula. The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4. Cefuroxime contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. The diluent chamber contains Dextrose Injection USP. The concentration of Hydrous Dextrose USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Hydrous Dextrose USP has the following structural (molecular) formula. The molecular weight of Hydrous Dextrose USP is 198.17. Dextrose hydrous USP has been added to the diluent to adjust osmolality (approximately 2.05 g and 1.45 g to 750 mg and 1.5 g dosages, respectively). After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted, the approximate osmolality of the reconstituted solution for Cefuroxime for Injection USP and Dextrose Injection USP is 290 mOsmol/kg. Not made with natural rubber latex, PVC or Di (2-ethylhexyl) phthalate (DEHP). The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-3114-11</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-3114-11)  &gt; 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-3114-11</NDC11Code>
    <ProductNDC>0264-3114</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefuroxime And Dextrose</ProprietaryName>
    <NonProprietaryName>Cefuroxime And Dextrose</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20010221</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050780</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>CEFUROXIME SODIUM</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-12-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20010221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefuroxime for Injection USP and Dextrose Injection USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: 1 Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, and Escherichia coli. , 2 Urinary Tract Infections caused by Escherichia coli and Klebsiella spp. , 3 Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp. , 4 Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp. , 5 Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains). , 6 Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females. , 7 Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase producing strains).</IndicationAndUsage>
    <Description>Cefuroxime for Injection USP and Dextrose Injection USP is a sterile, nonpyrogenic, single use, packaged combination of Cefuroxime Sodium USP (crystalline) and Dextrose Injection USP (diluent) in the DUPLEX® sterile container. The DUPLEX® Container is a flexible dual chamber container. The drug chamber is filled with sterile crystalline Cefuroxime for Injection USP, a semi-synthetic, broad-spectrum, cephalosporin antibacterial for parenteral administration. It is the sodium salt of (6R,7R)-7-[2-(2-furyl)glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate, 72-(Z)-(O-methyloxime), carbamate (ester). Cefuroxime Sodium USP has the following structural formula. The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4. Cefuroxime contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. The diluent chamber contains Dextrose Injection USP. The concentration of Hydrous Dextrose USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Hydrous Dextrose USP has the following structural (molecular) formula. The molecular weight of Hydrous Dextrose USP is 198.17. Dextrose hydrous USP has been added to the diluent to adjust osmolality (approximately 2.05 g and 1.45 g to 750 mg and 1.5 g dosages, respectively). After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted, the approximate osmolality of the reconstituted solution for Cefuroxime for Injection USP and Dextrose Injection USP is 290 mOsmol/kg. Not made with natural rubber latex, PVC or Di (2-ethylhexyl) phthalate (DEHP). The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-3123-11</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-3123-11)  &gt; 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-3123-11</NDC11Code>
    <ProductNDC>0264-3123</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefoxitin And Dextrose</ProprietaryName>
    <NonProprietaryName>Cefoxitin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20060310</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA065214</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>CEFOXITIN SODIUM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-10-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060310</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefoxitin for Injection and Dextrose Injection is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible isolates of the designated bacteria (1): 1 Lower respiratory tract infections (1.1);, 2 Urinary tract infections (1.2);, 3 Intra-abdominal infections (1.3);, 4 Gynecological infections (1.4);, 5 Septicemia (1.5);, 6 Bone and joint infections (1.6);, 7 Skin and skin structure infections (1.7);, 8 Prophylaxis (1.8).</IndicationAndUsage>
    <Description>Cefoxitin for Injection and Dextrose Injection is a sterile, nonpyrogenic, single-dose packaged combination of cefoxitin sodium USP and Dextrose Injection (diluent) in the DUPLEX® sterile container. The DUPLEX® Container is a flexible dual chamber container. The drug chamber is filled with cefoxitin sodium USP, a semi-synthetic, broad-spectrum cephalosporin antibacterial sealed under nitrogen for intravenous administration. Cefoxitin sodium USP is derived from cephamycin C, which is produced by Streptomyces lactamdurans. Its chemical name is sodium (6R,7S)-3-(hydroxymethyl)-7-methoxy-8-oxo-7-[2-(2-thienyl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate carbamate (ester). The empirical formula is C16H16N3NaO7S2, and the molecular weight is 449.44. The structural formula is. Cefoxitin sodium contains approximately 53.8 mg (2.3 mEq) of sodium per gram of cefoxitin activity. The diluent chamber contains Dextrose Injection. The concentration of  Dextrose Hydrous USP in Water for Injection USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose Hydrous USP has been added to adjust the osmolality to approximately 290 mOsmol/kg (approximately 2 g (4% w/v) and 1.1 g (2.2% w/v) to the 1 g and 2 g doses, respectively). Dextrose Injection is sterile, nonpyrogenic, and contains no bacteriostatic and antimicrobial agents. Dextrose Hydrous USP has the following structural (molecular) formula. The molecular weight of Dextrose Hydrous USP is 198.17. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted according to instructions in the product labeling, the approximate osmolality of the reconstituted solution of Cefoxitin for Injection and Dextrose Injection is approximately 290 mOsmol/kg. After reconstitution, each 50 mL contains 1 gram of cefoxitin (equivalent to 1.05 gram of cefoxitin sodium) or 2 grams of cefoxitin (equivalent to 2.10 grams of cefoxitin sodium), with a pH of approximately 6.5. Solutions of Cefoxitin for Injection and Dextrose Injection range from  colorless to light amber. The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-3125-11</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-3125-11)  &gt; 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-3125-11</NDC11Code>
    <ProductNDC>0264-3125</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefoxitin And Dextrose</ProprietaryName>
    <NonProprietaryName>Cefoxitin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20060310</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA065214</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>CEFOXITIN SODIUM</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-10-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060310</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefoxitin for Injection and Dextrose Injection is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible isolates of the designated bacteria (1): 1 Lower respiratory tract infections (1.1);, 2 Urinary tract infections (1.2);, 3 Intra-abdominal infections (1.3);, 4 Gynecological infections (1.4);, 5 Septicemia (1.5);, 6 Bone and joint infections (1.6);, 7 Skin and skin structure infections (1.7);, 8 Prophylaxis (1.8).</IndicationAndUsage>
    <Description>Cefoxitin for Injection and Dextrose Injection is a sterile, nonpyrogenic, single-dose packaged combination of cefoxitin sodium USP and Dextrose Injection (diluent) in the DUPLEX® sterile container. The DUPLEX® Container is a flexible dual chamber container. The drug chamber is filled with cefoxitin sodium USP, a semi-synthetic, broad-spectrum cephalosporin antibacterial sealed under nitrogen for intravenous administration. Cefoxitin sodium USP is derived from cephamycin C, which is produced by Streptomyces lactamdurans. Its chemical name is sodium (6R,7S)-3-(hydroxymethyl)-7-methoxy-8-oxo-7-[2-(2-thienyl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate carbamate (ester). The empirical formula is C16H16N3NaO7S2, and the molecular weight is 449.44. The structural formula is. Cefoxitin sodium contains approximately 53.8 mg (2.3 mEq) of sodium per gram of cefoxitin activity. The diluent chamber contains Dextrose Injection. The concentration of  Dextrose Hydrous USP in Water for Injection USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose Hydrous USP has been added to adjust the osmolality to approximately 290 mOsmol/kg (approximately 2 g (4% w/v) and 1.1 g (2.2% w/v) to the 1 g and 2 g doses, respectively). Dextrose Injection is sterile, nonpyrogenic, and contains no bacteriostatic and antimicrobial agents. Dextrose Hydrous USP has the following structural (molecular) formula. The molecular weight of Dextrose Hydrous USP is 198.17. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted according to instructions in the product labeling, the approximate osmolality of the reconstituted solution of Cefoxitin for Injection and Dextrose Injection is approximately 290 mOsmol/kg. After reconstitution, each 50 mL contains 1 gram of cefoxitin (equivalent to 1.05 gram of cefoxitin sodium) or 2 grams of cefoxitin (equivalent to 2.10 grams of cefoxitin sodium), with a pH of approximately 6.5. Solutions of Cefoxitin for Injection and Dextrose Injection range from  colorless to light amber. The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-3153-11</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-3153-11)  &gt; 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-3153-11</NDC11Code>
    <ProductNDC>0264-3153</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ceftriaxone And Dextrose</ProprietaryName>
    <NonProprietaryName>Ceftriaxone</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20050420</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050796</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>CEFTRIAXONE SODIUM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-01-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20050420</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ceftriaxone for Injection and Dextrose Injection is indicated for the treatment of the following infections when caused by susceptible bacteria.</IndicationAndUsage>
    <Description>Ceftriaxone for Injection and Dextrose Injection is a sterile, nonpyrogenic, single-dose, packaged combination of Ceftriaxone Sodium and Dextrose Injection (diluent) in the DUPLEX® sterile container. The DUPLEX® Container is a flexible dual chamber container. The drug chamber is filled with ceftriaxone sodium, a sterile, semisynthetic, broad-spectrum cephalosporin antibacterial for intravenous administration. Ceftriaxone sodium is (6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 72-(Z)-(O-methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is C18H16N8Na2O7S33.5H2O. It has a calculated molecular weight of 661.60 and the following structural formula. Ceftriaxone sodium is supplied as a dry powder form equivalent to either 1 g or 2 g of ceftriaxone. Ceftriaxone sodium is a white to yellowish-orange crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of ceftriaxone sodium solutions ranges from light yellow to amber, depending on the length of storage and concentration. Ceftriaxone sodium contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity. The diluent chamber contains Dextrose Injection. The concentration of Hydrous Dextrose in Water for Injection USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose USP has been added to adjust osmolality (approximately 1.87 g and 1.11 g to 1 g and 2 g dosages, respectively). Dextrose Injection is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Hydrous Dextrose USP has the following structural (molecular) formula. The molecular weight of Hydrous Dextrose USP is 198.17. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted, the approximate osmolality for the reconstituted solution for Ceftriaxone for Injection and Dextrose Injection is 290 mOsmol/kg. Not made with natural rubber latex, PVC or DEHP. The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-3155-11</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-3155-11)  &gt; 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-3155-11</NDC11Code>
    <ProductNDC>0264-3155</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ceftriaxone And Dextrose</ProprietaryName>
    <NonProprietaryName>Ceftriaxone</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20050420</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050796</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>CEFTRIAXONE SODIUM</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-01-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20050420</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ceftriaxone for Injection and Dextrose Injection is indicated for the treatment of the following infections when caused by susceptible bacteria.</IndicationAndUsage>
    <Description>Ceftriaxone for Injection and Dextrose Injection is a sterile, nonpyrogenic, single-dose, packaged combination of Ceftriaxone Sodium and Dextrose Injection (diluent) in the DUPLEX® sterile container. The DUPLEX® Container is a flexible dual chamber container. The drug chamber is filled with ceftriaxone sodium, a sterile, semisynthetic, broad-spectrum cephalosporin antibacterial for intravenous administration. Ceftriaxone sodium is (6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 72-(Z)-(O-methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is C18H16N8Na2O7S33.5H2O. It has a calculated molecular weight of 661.60 and the following structural formula. Ceftriaxone sodium is supplied as a dry powder form equivalent to either 1 g or 2 g of ceftriaxone. Ceftriaxone sodium is a white to yellowish-orange crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of ceftriaxone sodium solutions ranges from light yellow to amber, depending on the length of storage and concentration. Ceftriaxone sodium contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity. The diluent chamber contains Dextrose Injection. The concentration of Hydrous Dextrose in Water for Injection USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose USP has been added to adjust osmolality (approximately 1.87 g and 1.11 g to 1 g and 2 g dosages, respectively). Dextrose Injection is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Hydrous Dextrose USP has the following structural (molecular) formula. The molecular weight of Hydrous Dextrose USP is 198.17. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted, the approximate osmolality for the reconstituted solution for Ceftriaxone for Injection and Dextrose Injection is 290 mOsmol/kg. Not made with natural rubber latex, PVC or DEHP. The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-3183-11</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-3183-11)  / 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-3183-11</NDC11Code>
    <ProductNDC>0264-3183</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meropenem And Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Meropenem And Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20150430</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA202106</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>MEROPENEM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/50mL</StrengthUnit>
    <Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Meropenem for Injection and Sodium Chloride 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 requiring the full adult dose only). (1.1)  , 2 Complicated intra-abdominal infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.2)  , 3 Bacterial meningitis (pediatric patients 3 months of age and older requiring the full adult dose only). (1.3) .</IndicationAndUsage>
    <Description>Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial drug for intravenous administration. Meropenem 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 empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for injection is a white to pale yellow crystalline powder containing meropenem trihydrate and sodium carbonate. The constituted 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. Meropenem for Injection USP and Sodium Chloride Injection USP is supplied as a sterile, nonpyrogenic, single-dose packaged combination of meropenem (drug chamber) and 50 mL of sodium chloride (diluent) in the DUPLEX® sterile container. When reconstituted as instructed, each 1 gram Meropenem for injection in the DUPLEX® Container will deliver 1 gram of meropenem and a total sodium content of 290.2 mg (12.6 mEq). Each 500 mg Meropenem for injection in the DUPLEX® Container will deliver 500 mg of meropenem and a total sodium content of 245.1 mg (10.7 mEq) [see Dosage and Administration (2.4)]. The osmolality of the reconstituted solution of Meropenem for Injection USP and Sodium Chloride Injection USP is approximately 356 mOsmol/kg for the 500 mg dose and approximately 417 mOsmol/kg for the 1 gram dose. The DUPLEX® Container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. Not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP).</Description>
  </NDC>
</NDCList>