RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>44567-435-24</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (44567-435-24)  / 1 BAG in 1 POUCH / 50 mL in 1 BAG</PackageDescription>
    <NDC11Code>44567-0435-24</NDC11Code>
    <ProductNDC>44567-435</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levofloxacin</ProprietaryName>
    <NonProprietaryName>Levofloxacin</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20160414</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090343</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>LEVOFLOXACIN</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160414</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levofloxacin Injection in 5% dextrose is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).</IndicationAndUsage>
    <Description>Levofloxacin Injection is a synthetic broad-spectrum antibacterial agent for intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4- benzoxazine-6-carboxylic acid hemihydrate. Figure 1 : The Chemical Structure of Levofloxacin. The empirical formula is C18H20FN3O4 ● ½ H2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg per mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg per mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg per mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3&gt;Cu+2&gt;Zn+2&gt;Mg+2&gt;Ca+2.</Description>
  </NDC>
  <NDC>
    <NDCCode>20276-435-24</NDCCode>
    <PackageDescription>24 CLOTH in 1 PACKAGE (20276-435-24) </PackageDescription>
    <NDC11Code>20276-0435-24</NDC11Code>
    <ProductNDC>20276-435</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Wet Wipes</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200518</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Delta Brands, Inc</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.13</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230721</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>decreases bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55758-435-24</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (55758-435-24)  / 24 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>55758-0435-24</NDC11Code>
    <ProductNDC>55758-435</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dolodent Toothache</ProprietaryName>
    <ProprietaryNameSuffix>For Adults</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen, Caffeine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240730</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>Pharmadel LLC</LabelerName>
    <SubstanceName>CAFFEINE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>65; 500</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240730</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of minor aches and pains due to: : 1 toothache , 2 headache, 3 and to reduce fever .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>62135-435-24</NDCCode>
    <PackageDescription>2 TRAY in 1 BOX (62135-435-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-435-05) </PackageDescription>
    <NDC11Code>62135-0435-24</NDC11Code>
    <ProductNDC>62135-435</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Citrate And Citric Acid</ProprietaryName>
    <NonProprietaryName>Potassium Citrate And Citric Acid</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221208</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Chartwell RX, LLC</LabelerName>
    <SubstanceName>POTASSIUM CITRATE; CITRIC ACID MONOHYDRATE</SubstanceName>
    <StrengthNumber>1100; 334</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250404</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium citrate and citric acid oral solution is an effective alkalinizing agent useful in those conditions where long-term maintenance of an alkaline urine is desirable, such as in patients with uric acid and cystine calculi of the urinary tract, especially when the administration of sodium salts is undesirable or contraindicated. In addition, it is a valuable adjuvant when administered with uricosuric agents in gout therapy, since urates tend to crystallize out of an acid urine. It is also effective in correcting the acidosis of certain renal tubular disorders where the administration of potassium citrate may be preferable. This product is highly concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M. dose. This product alkalinizes the urine without producing a systemic alkalosis in recommended dosage. It is highly palatable, pleasant tasting and tolerable, even when administered for long periods. Potassium citrate does not neutralize the gastric juice or disturb digestion.</IndicationAndUsage>
    <Description>Potassium Citrate and Citric Acid Oral Solution, USP is a stable red colored and cherry flavored oral systemic alkalizer containing potassium citrate and citric acid in a sugar-free, non-alcoholic base. Potassium Citrate and Citric Acid Oral Solution, USP contains in each teaspoonful (5 mL). Potassium Citrate Monohydrate, USP  1100 mg. Citric Acid Monohydrate, USP  334 mg. Each mL contains 2 mEq potassium ion and is equivalent to 2 mEq bicarbonate (HCO 3). Inactive Ingredients: saccharin sodium, sodium benzoate, sorbitol solution, FD&amp;C red # 40, purified water, and wild cherry flavor. ACTIONS. Potassium citrate is absorbed and metabolized to potassium bicarbonate, thus acting as a systemic alkalizer. The effects are essentially those of chlorides before absorption and those of bicarbonates subsequently. Oxidation is virtually complete so that less than 5% of the potassium citrate is excreted in the urine unchanged.</Description>
  </NDC>
  <NDC>
    <NDCCode>68999-435-24</NDCCode>
    <PackageDescription>2 TRAY in 1 BOX (68999-435-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-435-05) </PackageDescription>
    <NDC11Code>68999-0435-24</NDC11Code>
    <ProductNDC>68999-435</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Citrate And Citric Acid</ProprietaryName>
    <NonProprietaryName>Potassium Citrate And Citric Acid</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221208</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Chartwell Governmental &amp; Specialty RX, LLC.</LabelerName>
    <SubstanceName>POTASSIUM CITRATE; CITRIC ACID MONOHYDRATE</SubstanceName>
    <StrengthNumber>1100; 334</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium citrate and citric acid oral solution is an effective alkalinizing agent useful in those conditions where long-term maintenance of an alkaline urine is desirable, such as in patients with uric acid and cystine calculi of the urinary tract, especially when the administration of sodium salts is undesirable or contraindicated. In addition, it is a valuable adjuvant when administered with uricosuric agents in gout therapy, since urates tend to crystallize out of an acid urine. It is also effective in correcting the acidosis of certain renal tubular disorders where the administration of potassium citrate may be preferable. This product is highly concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M. dose. This product alkalinizes the urine without producing a systemic alkalosis in recommended dosage. It is highly palatable, pleasant tasting and tolerable, even when administered for long periods. Potassium citrate does not neutralize the gastric juice or disturb digestion.</IndicationAndUsage>
    <Description>Potassium Citrate and Citric Acid Oral Solution, USP is a stable red colored and cherry flavored oral systemic alkalizer containing potassium citrate and citric acid in a sugar-free, non-alcoholic base. Potassium Citrate and Citric Acid Oral Solution, USP contains in each teaspoonful (5 mL). Potassium Citrate Monohydrate, USP 1100 mg. Citric Acid Monohydrate, USP 334 mg. Each mL contains 2 mEq potassium ion and is equivalent to 2 mEq bicarbonate (HCO 3). Inactive Ingredients: saccharin sodium, sodium benzoate, sorbitol solution, FD&amp;C red # 40, purified water, and wild cherry flavor. ACTIONS. Potassium citrate is absorbed and metabolized to potassium bicarbonate, thus acting as a systemic alkalizer. The effects are essentially those of chlorides before absorption and those of bicarbonates subsequently. Oxidation is virtually complete so that less than 5% of the potassium citrate is excreted in the urine unchanged.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-170-24</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (44567-170-24)  / 1 BAG in 1 POUCH (44567-170-01)  / 50 mL in 1 BAG</PackageDescription>
    <NDC11Code>44567-0170-24</NDC11Code>
    <ProductNDC>44567-170</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Magnesium Sulfate In Water</ProprietaryName>
    <NonProprietaryName>Magnesium Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180109</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207350</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.</IndicationAndUsage>
    <Description>Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and 8% concentrations. SeeHOW SUPPLIEDsection for the content and characteristics of available dosage forms and sizes. Magnesium Sulfate, USP heptahydrate is chemically designated MgSO4  7H2O, colorless crystals or white powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The single port bag is made of Nexcel M312A material, a 5-layer, polyolefin based on co-extrude film. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-410-24</NDCCode>
    <PackageDescription>24 BAG in 1 CARTON (44567-410-24)  / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>44567-0410-24</NDC11Code>
    <ProductNDC>44567-410</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Magnesium Sulfate In Dextrose</ProprietaryName>
    <NonProprietaryName>Magnesium Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20160308</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207349</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160308</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Magnesium Sulfate in 5% Dextrose Injection, USP is indicated for: 1 Prevention of eclampsia in patients with preeclampsia, 2 Treatment of seizures and prevention of recurrent seizures in patients with eclampsia.</IndicationAndUsage>
    <Description>Magnesium Sulfate in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate and dextrose in water for injection for intravenous use. Each 100 mL contains 1 gram of magnesium sulfate heptahydrate and dextrose, hydrous 5 grams in water for injection [see How Supplied/Storage and Handling (16)]. Magnesium Sulfate in 5% Dextrose Injection, USP may contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). Magnesium Sulfate, USP heptahydrate is chemically known as sulfuric acid magnesium salt (1:1), heptahydrate and chemically designated MgSO4 ∙ 7H2O, with a molecular weight of 246.47. It occurs as colorless crystals or white powder freely soluble in water. Dextrose, USP is chemically designated D-glucose, monohydrate, a hexose sugar freely soluble in water. The molecular formula is C6H12O6 ∙ H2O and the molecular weight is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Water can permeate from inside the flexible plastic container (polyvinylchloride) into the overwrap [see Dosage and Administration (2.1)] but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-420-24</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (44567-420-24)  / 1 BAG in 1 POUCH (44567-420-01)  / 50 mL in 1 BAG</PackageDescription>
    <NDC11Code>44567-0420-24</NDC11Code>
    <ProductNDC>44567-420</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Magnesium Sulfate In Water</ProprietaryName>
    <NonProprietaryName>Magnesium Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180109</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207350</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.</IndicationAndUsage>
    <Description>Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and 8% concentrations. SeeHOW SUPPLIEDsection for the content and characteristics of available dosage forms and sizes. Magnesium Sulfate, USP heptahydrate is chemically designated MgSO4  7H2O, colorless crystals or white powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The single port bag is made of Nexcel M312A material, a 5-layer, polyolefin based on co-extrude film. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-421-24</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (44567-421-24)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>44567-0421-24</NDC11Code>
    <ProductNDC>44567-421</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Magnesium Sulfate In Water</ProprietaryName>
    <NonProprietaryName>Magnesium Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180109</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207350</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.</IndicationAndUsage>
    <Description>Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and 8% concentrations. SeeHOW SUPPLIEDsection for the content and characteristics of available dosage forms and sizes. Magnesium Sulfate, USP heptahydrate is chemically designated MgSO4  7H2O, colorless crystals or white powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The single port bag is made of Nexcel M312A material, a 5-layer, polyolefin based on co-extrude film. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-422-24</NDCCode>
    <PackageDescription>24 BAG in 1 CARTON (44567-422-24)  / 500 mL in 1 BAG</PackageDescription>
    <NDC11Code>44567-0422-24</NDC11Code>
    <ProductNDC>44567-422</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Magnesium Sulfate In Water</ProprietaryName>
    <NonProprietaryName>Magnesium Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180109</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207350</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>g/500mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.</IndicationAndUsage>
    <Description>Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and 8% concentrations. SeeHOW SUPPLIEDsection for the content and characteristics of available dosage forms and sizes. Magnesium Sulfate, USP heptahydrate is chemically designated MgSO4  7H2O, colorless crystals or white powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The single port bag is made of Nexcel M312A material, a 5-layer, polyolefin based on co-extrude film. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-424-24</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (44567-424-24)  / 1 BAG in 1 POUCH / 50 mL in 1 BAG</PackageDescription>
    <NDC11Code>44567-0424-24</NDC11Code>
    <ProductNDC>44567-424</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Magnesium Sulfate In Water</ProprietaryName>
    <NonProprietaryName>Magnesium Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180109</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207350</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.</IndicationAndUsage>
    <Description>Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and 8% concentrations. SeeHOW SUPPLIEDsection for the content and characteristics of available dosage forms and sizes. Magnesium Sulfate, USP heptahydrate is chemically designated MgSO4  7H2O, colorless crystals or white powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The single port bag is made of Nexcel M312A material, a 5-layer, polyolefin based on co-extrude film. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-436-24</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (44567-436-24)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>44567-0436-24</NDC11Code>
    <ProductNDC>44567-436</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levofloxacin</ProprietaryName>
    <NonProprietaryName>Levofloxacin</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20160414</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090343</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>LEVOFLOXACIN</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160414</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levofloxacin Injection in 5% dextrose is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).</IndicationAndUsage>
    <Description>Levofloxacin Injection is a synthetic broad-spectrum antibacterial agent for intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4- benzoxazine-6-carboxylic acid hemihydrate. Figure 1 : The Chemical Structure of Levofloxacin. The empirical formula is C18H20FN3O4 ● ½ H2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg per mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg per mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg per mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3&gt;Cu+2&gt;Zn+2&gt;Mg+2&gt;Ca+2.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-437-24</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (44567-437-24)  / 1 BAG in 1 POUCH / 150 mL in 1 BAG</PackageDescription>
    <NDC11Code>44567-0437-24</NDC11Code>
    <ProductNDC>44567-437</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levofloxacin</ProprietaryName>
    <NonProprietaryName>Levofloxacin</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20160414</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090343</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>LEVOFLOXACIN</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160414</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levofloxacin Injection in 5% dextrose is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).</IndicationAndUsage>
    <Description>Levofloxacin Injection is a synthetic broad-spectrum antibacterial agent for intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4- benzoxazine-6-carboxylic acid hemihydrate. Figure 1 : The Chemical Structure of Levofloxacin. The empirical formula is C18H20FN3O4 ● ½ H2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg per mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg per mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg per mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3&gt;Cu+2&gt;Zn+2&gt;Mg+2&gt;Ca+2.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-602-24</NDCCode>
    <PackageDescription>24 BAG in 1 CARTON (44567-602-24)  / 50 mL in 1 BAG (44567-602-01) </PackageDescription>
    <NDC11Code>44567-0602-24</NDC11Code>
    <ProductNDC>44567-602</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexmedetomidine In Dextrose</ProprietaryName>
    <NonProprietaryName>Dexmedetomidine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20160419</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206628</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection is a alpha2 adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection by continuous infusion not to exceed 24 hours. (1.1) , 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2) .</IndicationAndUsage>
    <Description>Dexmedetomidine Injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine in 5% Dextrose Injection is a sterile ready-to-use, nonpyrogenic solution suitable for intravenous infusion. Dexmedetomidine Injection and Dexmedetomidine in Dextrose Injection contains the dexmedetomidine as active pharmaceutical ingredient in the form of the hydrochloride salt form. Dexmedetomidine hydrochloride is a central alpha-2 adrenergic agonist. Structurally it is the S-enantiomer of medetomidine and is chemically described as 4-[(S)-α,2,3-Trimethylbenzyl]imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.74 and the empirical formula is C13H16N2  HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7. Each mL contains 118 mcg of dexmedetomidine hydrochloride USP, equivalent to 100 mcg (0.1 mg) of dexmedetomidine, 1.6 mg of methylparaben NF and 0.2 mg of propylparaben NF, as preservatives and 9 mg of sodium chloride USP, as tonicity agent in water for injection. Dexmedetomidine in 5% Dextrose Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride USP, equivalent to 4 mcg of dexmedetomidine, and 50 mg dextrose monohydrate USP, as tonicity agent, in water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-603-24</NDCCode>
    <PackageDescription>24 BAG in 1 CARTON (44567-603-24)  / 100 mL in 1 BAG (44567-603-01) </PackageDescription>
    <NDC11Code>44567-0603-24</NDC11Code>
    <ProductNDC>44567-603</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexmedetomidine In Dextrose</ProprietaryName>
    <NonProprietaryName>Dexmedetomidine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20160419</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206628</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection is a alpha2 adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection by continuous infusion not to exceed 24 hours. (1.1) , 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2) .</IndicationAndUsage>
    <Description>Dexmedetomidine Injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine in 5% Dextrose Injection is a sterile ready-to-use, nonpyrogenic solution suitable for intravenous infusion. Dexmedetomidine Injection and Dexmedetomidine in Dextrose Injection contains the dexmedetomidine as active pharmaceutical ingredient in the form of the hydrochloride salt form. Dexmedetomidine hydrochloride is a central alpha-2 adrenergic agonist. Structurally it is the S-enantiomer of medetomidine and is chemically described as 4-[(S)-α,2,3-Trimethylbenzyl]imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.74 and the empirical formula is C13H16N2  HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7. Each mL contains 118 mcg of dexmedetomidine hydrochloride USP, equivalent to 100 mcg (0.1 mg) of dexmedetomidine, 1.6 mg of methylparaben NF and 0.2 mg of propylparaben NF, as preservatives and 9 mg of sodium chloride USP, as tonicity agent in water for injection. Dexmedetomidine in 5% Dextrose Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride USP, equivalent to 4 mcg of dexmedetomidine, and 50 mg dextrose monohydrate USP, as tonicity agent, in water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-620-24</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (44567-620-24)  / 1 BAG in 1 POUCH (44567-620-01)  / 50 mL in 1 BAG</PackageDescription>
    <NDC11Code>44567-0620-24</NDC11Code>
    <ProductNDC>44567-620</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcium Gluconate In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Calcium Gluconate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181026</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210906</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>CALCIUM GLUCONATE MONOHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181026</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Calcium Gluconate in Sodium Chloride Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use. The safety of Calcium Gluconate in Sodium Chloride Injection for long term use has not been established.</IndicationAndUsage>
    <Description>Calcium Gluconate in Sodium Chloride Injection is a sterile, preservative-free, nonpyrogenic solution of calcium gluconate, a form of calcium, for intravenous use. Calcium Gluconate is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14 H2O. Molecular weight: 448.39. Solubility in water: 3.5 g/100 mL at 25°C. Calcium Gluconate in Sodium Chloride Injection is available as 1,000 mg per 50 mL (equivalent to 18.8 mg per mL calcium gluconate anhydrous), 1,000 mg per 100 mL (equivalent to 9.4 mg per mL calcium gluconate anhydrous) or 2,000 mg per 100 mL (equivalent to 18.8 mg per mL calcium gluconate anhydrous) in single-dose bags. Table 3. Calcium Gluconate Formulations.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-620-84</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (44567-620-84)  / 1 BAG in 1 POUCH (44567-620-02)  / 50 mL in 1 BAG</PackageDescription>
    <NDC11Code>44567-0620-84</NDC11Code>
    <ProductNDC>44567-620</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcium Gluconate In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Calcium Gluconate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181026</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210906</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>CALCIUM GLUCONATE MONOHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Calcium Gluconate in Sodium Chloride Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use. The safety of Calcium Gluconate in Sodium Chloride Injection for long term use has not been established.</IndicationAndUsage>
    <Description>Calcium Gluconate in Sodium Chloride Injection is a sterile, preservative-free, nonpyrogenic solution of calcium gluconate, a form of calcium, for intravenous use. Calcium Gluconate is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14 H2O. Molecular weight: 448.39. Solubility in water: 3.5 g/100 mL at 25°C. Calcium Gluconate in Sodium Chloride Injection is available as 1,000 mg per 50 mL (equivalent to 18.8 mg per mL calcium gluconate anhydrous), 2,000 mg per 100 mL (equivalent to 18.8 mg per mL calcium gluconate anhydrous) in single-dose bags. Table 3. Calcium Gluconate Formulations.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-621-24</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (44567-621-24)  / 1 BAG in 1 POUCH (44567-621-01)  / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>44567-0621-24</NDC11Code>
    <ProductNDC>44567-621</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcium Gluconate In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Calcium Gluconate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181026</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210906</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>CALCIUM GLUCONATE MONOHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181026</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Calcium Gluconate in Sodium Chloride Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use. The safety of Calcium Gluconate in Sodium Chloride Injection for long term use has not been established.</IndicationAndUsage>
    <Description>Calcium Gluconate in Sodium Chloride Injection is a sterile, preservative-free, nonpyrogenic solution of calcium gluconate, a form of calcium, for intravenous use. Calcium Gluconate is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14 H2O. Molecular weight: 448.39. Solubility in water: 3.5 g/100 mL at 25°C. Calcium Gluconate in Sodium Chloride Injection is available as 1,000 mg per 50 mL (equivalent to 18.8 mg per mL calcium gluconate anhydrous), 1,000 mg per 100 mL (equivalent to 9.4 mg per mL calcium gluconate anhydrous) or 2,000 mg per 100 mL (equivalent to 18.8 mg per mL calcium gluconate anhydrous) in single-dose bags. Table 3. Calcium Gluconate Formulations.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-621-84</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (44567-621-84)  / 1 BAG in 1 POUCH (44567-621-02)  / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>44567-0621-84</NDC11Code>
    <ProductNDC>44567-621</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcium Gluconate In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Calcium Gluconate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181026</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210906</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>CALCIUM GLUCONATE MONOHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Calcium Gluconate in Sodium Chloride Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use. The safety of Calcium Gluconate in Sodium Chloride Injection for long term use has not been established.</IndicationAndUsage>
    <Description>Calcium Gluconate in Sodium Chloride Injection is a sterile, preservative-free, nonpyrogenic solution of calcium gluconate, a form of calcium, for intravenous use. Calcium Gluconate is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14 H2O. Molecular weight: 448.39. Solubility in water: 3.5 g/100 mL at 25°C. Calcium Gluconate in Sodium Chloride Injection is available as 1,000 mg per 50 mL (equivalent to 18.8 mg per mL calcium gluconate anhydrous), 2,000 mg per 100 mL (equivalent to 18.8 mg per mL calcium gluconate anhydrous) in single-dose bags. Table 3. Calcium Gluconate Formulations.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-622-24</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (44567-622-24)  / 1 BAG in 1 POUCH (44567-622-01)  / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>44567-0622-24</NDC11Code>
    <ProductNDC>44567-622</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcium Gluconate In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Calcium Gluconate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210713</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210906</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>CALCIUM GLUCONATE MONOHYDRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210713</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Calcium Gluconate in Sodium Chloride Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use. The safety of Calcium Gluconate in Sodium Chloride Injection for long term use has not been established.</IndicationAndUsage>
    <Description>Calcium Gluconate in Sodium Chloride Injection is a sterile, preservative-free, nonpyrogenic solution of calcium gluconate, a form of calcium, for intravenous use. Calcium Gluconate is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14 H2O. Molecular weight: 448.39. Solubility in water: 3.5 g/100 mL at 25°C. Calcium Gluconate in Sodium Chloride Injection is available as 1,000 mg per 50 mL (equivalent to 18.8 mg per mL calcium gluconate anhydrous), 1,000 mg per 100 mL (equivalent to 9.4 mg per mL calcium gluconate anhydrous) or 2,000 mg per 100 mL (equivalent to 18.8 mg per mL calcium gluconate anhydrous) in single-dose bags. Table 3. Calcium Gluconate Formulations.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-750-24</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (44567-750-24)  / 1 BAG in 1 POUCH (44567-750-01)  / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>44567-0750-24</NDC11Code>
    <ProductNDC>44567-750</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metronidazole</ProprietaryName>
    <NonProprietaryName>Metronidazole</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250131</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206191</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>METRONIDAZOLE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250131</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection and other antibacterial drugs, Metronidazole Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Metronidazole Injection, USP is a sterile, parenteral dosage form of metronidazole in water. Each 100 mL of Metronidazole Injection, USP contains a sterile, nonpyrogenic, isotonic, buffered solution of Metronidazole, USP 500 mg, Sodium Chloride, USP 740 mg, Dibasic Sodium Phosphate Dihydrate, USP 75 mg and Citric Acid Anhydrous, USP 40 mg in Water for Injection, USP. Metronidazole Injection, USP has a calculated osmolality from 270 to 310 mOsmol/kg and a pH from 4.5 to 6.0. Sodium content: 13.5 mEq/container. Metronidazole is classified as a nitroimidazole antimicrobial and is administered by the intravenous route. Metronidazole, USP is chemically designated 2-methyl-5-nitroimidazole-1-ethanol (C6H9N3O3):. Not made with natural rubber latex. The flexible container is fabricated from a specially formulated non-plasticized, thermoplastic copolyolephine. The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-509-01</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (44567-509-01)  &gt; 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>44567-0509-01</NDC11Code>
    <ProductNDC>44567-509</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cisplatin</ProprietaryName>
    <NonProprietaryName>Cisplatin</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20120113</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018057</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>CISPLATIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cisplatin Injection is indicated as therapy to be employed as follows:.</IndicationAndUsage>
    <Description>Cisplatin Injection infusion concentrate is a clear, colorless, sterile aqueous solution available in amber vials. Each 50 mL, 100 mL or 200 mL amber vial of infusion concentrate contains: 1 mg/mL cisplatin, 9 mg/mL sodium chloride, hydrochloric acid and sodium hydroxide to approximate pH of 4.0, and water for injection to a final volume of 50 mL, 100 mL or 200 mL respectively. Cisplatin Injection infusion concentrate must be further diluted prior to administration (see DOSAGE AND ADMINISTRATION, All Patients). The active ingredient, cisplatin, is a yellow to orange crystalline powder with the molecular formula PtCl2H6N2, and a molecular weight of 300.1. Cisplatin is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. It is soluble in water or saline at 1 mg/mL and in dimethylformamide at 24 mg/mL. It has a melting point of 207° C.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-510-01</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (44567-510-01)  &gt; 100 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>44567-0510-01</NDC11Code>
    <ProductNDC>44567-510</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cisplatin</ProprietaryName>
    <NonProprietaryName>Cisplatin</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20120113</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018057</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>CISPLATIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cisplatin Injection is indicated as therapy to be employed as follows:.</IndicationAndUsage>
    <Description>Cisplatin Injection infusion concentrate is a clear, colorless, sterile aqueous solution available in amber vials. Each 50 mL, 100 mL or 200 mL amber vial of infusion concentrate contains: 1 mg/mL cisplatin, 9 mg/mL sodium chloride, hydrochloric acid and sodium hydroxide to approximate pH of 4.0, and water for injection to a final volume of 50 mL, 100 mL or 200 mL respectively. Cisplatin Injection infusion concentrate must be further diluted prior to administration (see DOSAGE AND ADMINISTRATION, All Patients). The active ingredient, cisplatin, is a yellow to orange crystalline powder with the molecular formula PtCl2H6N2, and a molecular weight of 300.1. Cisplatin is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. It is soluble in water or saline at 1 mg/mL and in dimethylformamide at 24 mg/mL. It has a melting point of 207° C.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-511-01</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (44567-511-01)  &gt; 200 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>44567-0511-01</NDC11Code>
    <ProductNDC>44567-511</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cisplatin</ProprietaryName>
    <NonProprietaryName>Cisplatin</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20150415</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018057</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>CISPLATIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cisplatin Injection is indicated as therapy to be employed as follows:.</IndicationAndUsage>
    <Description>Cisplatin Injection infusion concentrate is a clear, colorless, sterile aqueous solution available in amber vials. Each 50 mL, 100 mL or 200 mL amber vial of infusion concentrate contains: 1 mg/mL cisplatin, 9 mg/mL sodium chloride, hydrochloric acid and sodium hydroxide to approximate pH of 4.0, and water for injection to a final volume of 50 mL, 100 mL or 200 mL respectively. Cisplatin Injection infusion concentrate must be further diluted prior to administration (see DOSAGE AND ADMINISTRATION, All Patients). The active ingredient, cisplatin, is a yellow to orange crystalline powder with the molecular formula PtCl2H6N2, and a molecular weight of 300.1. Cisplatin is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. It is soluble in water or saline at 1 mg/mL and in dimethylformamide at 24 mg/mL. It has a melting point of 207° C.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-600-04</NDCCode>
    <PackageDescription>4 VIAL in 1 CARTON (44567-600-04)  / 4 mL in 1 VIAL</PackageDescription>
    <NDC11Code>44567-0600-04</NDC11Code>
    <ProductNDC>44567-600</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexmedetomidine</ProprietaryName>
    <NonProprietaryName>Dexmedetomidine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20160419</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206628</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170126</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection is a alpha2 adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection by continuous infusion not to exceed 24 hours. (1.1) , 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2) .</IndicationAndUsage>
    <Description>Dexmedetomidine Injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine in 5% Dextrose Injection is a sterile ready-to-use, nonpyrogenic solution suitable for intravenous infusion. Dexmedetomidine Injection and Dexmedetomidine in Dextrose Injection contains the dexmedetomidine as active pharmaceutical ingredient in the form of the hydrochloride salt form. Dexmedetomidine hydrochloride is a central alpha-2 adrenergic agonist. Structurally it is the S-enantiomer of medetomidine and is chemically described as 4-[(S)-α,2,3-Trimethylbenzyl]imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.74 and the empirical formula is C13H16N2  HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7. Each mL contains 118 mcg of dexmedetomidine hydrochloride USP, equivalent to 100 mcg (0.1 mg) of dexmedetomidine, 1.6 mg of methylparaben NF and 0.2 mg of propylparaben NF, as preservatives and 9 mg of sodium chloride USP, as tonicity agent in water for injection. Dexmedetomidine in 5% Dextrose Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride USP, equivalent to 4 mcg of dexmedetomidine, and 50 mg dextrose monohydrate USP, as tonicity agent, in water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-601-04</NDCCode>
    <PackageDescription>4 VIAL in 1 CARTON (44567-601-04)  / 10 mL in 1 VIAL</PackageDescription>
    <NDC11Code>44567-0601-04</NDC11Code>
    <ProductNDC>44567-601</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexmedetomidine</ProprietaryName>
    <NonProprietaryName>Dexmedetomidine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20160419</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206628</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170126</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection is a alpha2 adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection by continuous infusion not to exceed 24 hours. (1.1) , 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2) .</IndicationAndUsage>
    <Description>Dexmedetomidine Injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine in 5% Dextrose Injection is a sterile ready-to-use, nonpyrogenic solution suitable for intravenous infusion. Dexmedetomidine Injection and Dexmedetomidine in Dextrose Injection contains the dexmedetomidine as active pharmaceutical ingredient in the form of the hydrochloride salt form. Dexmedetomidine hydrochloride is a central alpha-2 adrenergic agonist. Structurally it is the S-enantiomer of medetomidine and is chemically described as 4-[(S)-α,2,3-Trimethylbenzyl]imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.74 and the empirical formula is C13H16N2  HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7. Each mL contains 118 mcg of dexmedetomidine hydrochloride USP, equivalent to 100 mcg (0.1 mg) of dexmedetomidine, 1.6 mg of methylparaben NF and 0.2 mg of propylparaben NF, as preservatives and 9 mg of sodium chloride USP, as tonicity agent in water for injection. Dexmedetomidine in 5% Dextrose Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride USP, equivalent to 4 mcg of dexmedetomidine, and 50 mg dextrose monohydrate USP, as tonicity agent, in water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-706-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (44567-706-25)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
    <NDC11Code>44567-0706-25</NDC11Code>
    <ProductNDC>44567-706</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefazolin</ProprietaryName>
    <NonProprietaryName>Cefazolin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20150306</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065303</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>CEFAZOLIN SODIUM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150306</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefazolin for Injection, USP is indicated for the treatment of the following serious infections due to susceptible organisms. Respiratory Tract Infections: Due to S. pneumoniae, Klebsiella species, H. influenzae, S. aureus (penicillin-sensitive and penicillin-resistant), and group A beta-hemolytic streptococci. Injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin for Injection, USP is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Cefazolin for Injection, USP in the subsequent prevention of rheumatic fever are not available at present. Urinary Tract Infections: Due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterobacter and enterococci. Skin and Skin Structure Infections: Due to S. aureus (penicillin‑sensitive and penicillin-resistant), group A beta‑hemolytic streptococci, and other strains of streptococci. Biliary Tract Infections: Due to E. coli, various strains of streptococci, P. mirabilis, Klebsiella species, and S. aureus. Bone and Joint Infections: Due to S. aureus. Genital Infections: (i.e., prostatitis, epididymitis) due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterococci. Septicemia: Due to S. pneumoniae, S. aureus (penicillin‑sensitive and penicillin‑resistant), P. mirabilis, E. coli, and Klebsiella species. Endocarditis: Due to S. aureus (penicillin‑sensitive and penicillin‑resistant) and group A beta‑hemolytic streptococci. Perioperative Prophylaxis: The prophylactic administration of Cefazolin for Injection, USP preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high‑risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). The perioperative use of Cefazolin for Injection, USP may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open‑heart surgery and prosthetic arthroplasty). The prophylactic administration of Cefazolin for Injection, USP should usually be discontinued within a 24‑hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of Cefazolin for Injection, USP may be continued for 3 to 5 days following the completion of surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted. (See DOSAGE AND ADMINISTRATION.). To reduce the development of drug‑resistant bacteria and maintain the effectiveness of Cefazolin for Injection, USP and other antibacterial drugs, Cefazolin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Cefazolin for Injection, USP is a semi-synthetic cephalosporin for parenteral administration. It is the sodium salt of 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-carboxylic acid. Structural Formula. C14H13N8NaO4S3 M.W. 476.5. The pH of the reconstituted solution is between 4 and 6. Cefazolin for Injection, USP is a sterile white to cream powder supplied in vials. Each vial contains, cefazolin sodium equivalent to 500 mg or 1 gram of cefazolin. The sodium content is approximately 24 mg (1 mEq)/500 mg of cefazolin sodium or approximately 48 mg (2.1 mEq)/1 gram of cefazolin sodium. The color of Cefazolin for Injection, USP solutions may range from pale yellow to yellow without a change in potency. Cefazolin for Injection, USP is to be administered by intramuscular or intravenous routes.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-707-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (44567-707-25)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
    <NDC11Code>44567-0707-25</NDC11Code>
    <ProductNDC>44567-707</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefazolin</ProprietaryName>
    <NonProprietaryName>Cefazolin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20150306</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065303</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>CEFAZOLIN SODIUM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150306</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefazolin for Injection, USP is indicated for the treatment of the following serious infections due to susceptible organisms. Respiratory Tract Infections: Due to S. pneumoniae, Klebsiella species, H. influenzae, S. aureus (penicillin-sensitive and penicillin-resistant), and group A beta-hemolytic streptococci. Injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin for Injection, USP is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Cefazolin for Injection, USP in the subsequent prevention of rheumatic fever are not available at present. Urinary Tract Infections: Due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterobacter and enterococci. Skin and Skin Structure Infections: Due to S. aureus (penicillin‑sensitive and penicillin-resistant), group A beta‑hemolytic streptococci, and other strains of streptococci. Biliary Tract Infections: Due to E. coli, various strains of streptococci, P. mirabilis, Klebsiella species, and S. aureus. Bone and Joint Infections: Due to S. aureus. Genital Infections: (i.e., prostatitis, epididymitis) due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterococci. Septicemia: Due to S. pneumoniae, S. aureus (penicillin‑sensitive and penicillin‑resistant), P. mirabilis, E. coli, and Klebsiella species. Endocarditis: Due to S. aureus (penicillin‑sensitive and penicillin‑resistant) and group A beta‑hemolytic streptococci. Perioperative Prophylaxis: The prophylactic administration of Cefazolin for Injection, USP preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high‑risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). The perioperative use of Cefazolin for Injection, USP may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open‑heart surgery and prosthetic arthroplasty). The prophylactic administration of Cefazolin for Injection, USP should usually be discontinued within a 24‑hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of Cefazolin for Injection, USP may be continued for 3 to 5 days following the completion of surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted. (See DOSAGE AND ADMINISTRATION.). To reduce the development of drug‑resistant bacteria and maintain the effectiveness of Cefazolin for Injection, USP and other antibacterial drugs, Cefazolin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Cefazolin for Injection, USP is a semi-synthetic cephalosporin for parenteral administration. It is the sodium salt of 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-carboxylic acid. Structural Formula. C14H13N8NaO4S3 M.W. 476.5. The pH of the reconstituted solution is between 4 and 6. Cefazolin for Injection, USP is a sterile white to cream powder supplied in vials. Each vial contains, cefazolin sodium equivalent to 500 mg or 1 gram of cefazolin. The sodium content is approximately 24 mg (1 mEq)/500 mg of cefazolin sodium or approximately 48 mg (2.1 mEq)/1 gram of cefazolin sodium. The color of Cefazolin for Injection, USP solutions may range from pale yellow to yellow without a change in potency. Cefazolin for Injection, USP is to be administered by intramuscular or intravenous routes.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-804-01</NDCCode>
    <PackageDescription>1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (44567-804-01)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
    <NDC11Code>44567-0804-01</NDC11Code>
    <ProductNDC>44567-804</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
    <NonProprietaryName>Piperacillin And Tazobactam</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20091020</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090498</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
    <StrengthNumber>36; 4.5</StrengthNumber>
    <StrengthUnit>g/1; g/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091020</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Piperacillin and Tazobactam for Injection, for intravenous use is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a β-lactamase inhibitor indicated for the treatment of: : 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).</IndicationAndUsage>
    <Description>Piperacillin and Tazobactam for Injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin.  The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.  The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone.  Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and tazobactam contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Piperacillin and tazobactam is a white to off-white sterile, lyophilized powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass bottles.  This product does not contain excipients or preservatives. The pharmacy bulk package bottle is a container of sterile preparation which contains many single doses for parenteral use.  The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. Each Piperacillin and Tazobactam for Injection, USP 40.5 gram pharmacy bulk package bottle contains piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 grams of tazobactam sufficient for delivery of multiple doses. Meets USP Organic Impurities Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-0712-24</NDCCode>
    <PackageDescription>24 BAG in 1 CARTON (0338-0712-24)  / 50 mL in 1 BAG</PackageDescription>
    <NDC11Code>00338-0712-24</NDC11Code>
    <ProductNDC>0338-0712</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Daptomycin In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Daptomycin In Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220125</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA213645</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>DAPTOMYCIN</SubstanceName>
    <StrengthNumber>350</StrengthNumber>
    <StrengthUnit>mg/50mL</StrengthUnit>
    <Pharm_Classes>Lipopeptide Antibacterial [EPC], Lipopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Daptomycin in Sodium Chloride Injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) for whom appropriate dosing can be achieved (1.1) and, , 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients for whom appropriate dosing can be achieved, including those with right-sided infective endocarditis, (1.2), 3 Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age) for whom appropriate dosing can be achieved. (1.3).</IndicationAndUsage>
    <Description>Daptomycin in Sodium Chloride Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ℇ1-lactone. The chemical structure is. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin in Sodium Chloride Injection is a single-dose, frozen, premixed, iso-osmotic, sterile, nonpyrogenic. Each milliliter contains either 7 milligrams or 10 milligrams (mg) of daptomycin and the following inactive ingredients: dibasic sodium phosphate (0.55 mg), monobasic sodium phosphate (0.435 mg), sodium chloride (9 mg) and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. Contains no preservative. The solution is intended for intravenous use after thawing to room temperature. This GALAXY container is fabricated from a specially designed multilayer plastic. Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. However, the suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.</Description>
  </NDC>
</NDCList>