RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>67457-657-25</NDCCode>
    <PackageDescription>1 BAG in 1 POUCH (67457-657-25)  / 250 mL in 1 BAG</PackageDescription>
    <NDC11Code>67457-0657-25</NDC11Code>
    <ProductNDC>67457-657</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Esmolol Hydrochloride In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Esmolol Hydrochloride In Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180904</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206608</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>ESMOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180904</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Esmolol hydrochloride in sodium chloride injection is a beta adrenergic blocker indicated for the short-term treatment of: 1 Control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia (1.1), 2 Control of perioperative tachycardia and hypertension (1.2).</IndicationAndUsage>
    <Description>Esmolol Hydrochloride in Sodium Chloride Injection is a beta adrenergic receptor blocker with a very short duration of action (elimination half-life is approximately 9 minutes). Esmolol hydrochloride, USP is: : 1 (±)-Methyl p-[2-hydroxy-3-(isopropylamino) propoxy] hydrocinnamate hydrochloride and has the following structure:.</Description>
  </NDC>
  <NDC>
    <NDCCode>71052-657-25</NDCCode>
    <PackageDescription>25 g in 1 CONTAINER (71052-657-25) </PackageDescription>
    <NDC11Code>71052-0657-25</NDC11Code>
    <ProductNDC>71052-657</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Methylene Blue Monohydrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20201124</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>DARMERICA, LLC</LabelerName>
    <SubstanceName>METHYLENE BLUE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>g/1000g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-DEC-20</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>67457-187-50</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (67457-187-50)  &gt; 25 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>67457-0187-50</NDC11Code>
    <ProductNDC>67457-187</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aloprim</ProprietaryName>
    <NonProprietaryName>Allopurinol</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20070515</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020298</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>ALLOPURINOL SODIUM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/25mL</StrengthUnit>
    <Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-02-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ALOPRIM is indicated for the management of adult and pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy.</IndicationAndUsage>
    <Description>ALOPRIM (allopurinol) for Injection, a xanthine oxidase inhibitor, is a sterile, white, lyophilized powder or cake, in a single-dose vial for reconstitution. Each vial contains 500 mg of allopurinol equivalent to 580.7 mg of allopurinol sodium and 148 mg of sodium hydroxide as a solubilizer. Sodium hydroxide is also used as a pH adjuster. ALOPRIM (allopurinol) for Injection contains no preservatives. Allopurinol is a xanthine oxidase inhibitor. The chemical name for allopurinol sodium is 1,5-dihydro-4H-pyrazolo[3,4-d]pyrimidin-4-one monosodium salt. It is a white amorphous mass with a molecular weight of 158.09 and molecular formula C5H3N4NaO. The structural formula is. The pKa of allopurinol sodium is 9.31.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-196-02</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (67457-196-02)  &gt; 2 mL in 1 VIAL, MULTI-DOSE (67457-196-00) </PackageDescription>
    <NDC11Code>67457-0196-02</NDC11Code>
    <ProductNDC>67457-196</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Thiamine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Thiamine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20130604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091623</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>THIAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2021-06-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke’s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. Thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. Thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given.</IndicationAndUsage>
    <Description>Thiamine hydrochloride injection, USP is a sterile solution of thiamine hydrochloride in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration. Each mL contains: Thiamine hydrochloride 100 mg; monothioglycerol 0.5%; Water for Injection q.s. Sodium hydroxide may have been added for pH adjustment (2.5 to 4.5). Thiamine hydrochloride, or vitamin B1, occurs as white crystals or crystalline powder that usually has a slight characteristic odor. Freely soluble in water; soluble in glycerin; slightly soluble in alcohol; insoluble in ether and benzene. Thiamine is rapidly destroyed in neutral or alkaline solutions but is stable in the dry state. It is reasonably stable to heat in acid solution. The chemical name of thiamine hydrochloride is thiazolium,3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methylchloride, monohydrochloride and it has the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-207-25</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE (67457-207-25)  *  25 mL in 1 VIAL (67457-205-25)  *  25 mL in 1 VIAL, SINGLE-DOSE (67457-204-25) </PackageDescription>
    <NDC11Code>67457-0207-25</NDC11Code>
    <ProductNDC>67457-207</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexrazoxane Hydrochloride</ProprietaryName>
    <NonProprietaryName>Dexrazoxane</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20111118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200752</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67457-251-02</NDCCode>
    <PackageDescription>25 VIAL, GLASS in 1 CARTON (67457-251-02)  / 2 mL in 1 VIAL, GLASS (67457-251-00) </PackageDescription>
    <NDC11Code>67457-0251-02</NDC11Code>
    <ProductNDC>67457-251</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexmedetomidine</ProprietaryName>
    <NonProprietaryName>Dexmedetomidine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20140818</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202881</ApplicationNumber>
    <LabelerName>Mylan Institutional 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>2026-05-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140818</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dexmedetomidine injection is an 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 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), 3 Sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures. (1.2).</IndicationAndUsage>
    <Description>Dexmedetomidine injection USP, (100 mcg/mL), is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine injection contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha2-adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine. Dexmedetomidine hydrochloride chemical name is 1H-Imidazole, 4-[1-(2,3-dimethylphenyl)ethyl]-, monohydrochloride, (S)-;. Dexmedetomidine hydrochloride has a molecular weight of 236.74 and the empirical formula is C13H16N2 HCl and the structural formula is. Dexmedetomidine hydrochloride, USP is a solid, 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 intended to be used after dilution. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 118 mcg of dexmedetomidine hydrochloride (equivalent to 100 mcg or 0.1 mg of dexmedetomidine) and 9 mg of sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers. Each mL of dexmedetomidine injection contains 9 mg of sodium and less than 5 mg each of phosphorus and potassium.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-273-10</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (67457-273-10)  &gt; 10 mL in 1 VIAL, SINGLE-DOSE (67457-273-00) </PackageDescription>
    <NDC11Code>67457-0273-10</NDC11Code>
    <ProductNDC>67457-273</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methocarbamol</ProprietaryName>
    <NonProprietaryName>Methocarbamol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20141205</StartMarketingDate>
    <EndMarketingDate>20221130</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204404</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>METHOCARBAMOL</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20141205</StartMarketingDatePackage>
    <EndMarketingDatePackage>20221130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67457-281-01</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (67457-281-01)  &gt; 1 mL in 1 VIAL, MULTI-DOSE (67457-281-00) </PackageDescription>
    <NDC11Code>67457-0281-01</NDC11Code>
    <ProductNDC>67457-281</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pyridoxine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Pyridoxine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20160901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204879</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>PYRIDOXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67457-291-01</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (67457-291-01)  &gt; 1 mL in 1 VIAL, SINGLE-DOSE (67457-291-00) </PackageDescription>
    <NDC11Code>67457-0291-01</NDC11Code>
    <ProductNDC>67457-291</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20160429</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204680</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-04-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67457-316-25</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (67457-316-25)  &gt; 20 mL in 1 VIAL</PackageDescription>
    <NDC11Code>67457-0316-25</NDC11Code>
    <ProductNDC>67457-316</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Decitabine</ProprietaryName>
    <NonProprietaryName>Decitabine</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181010</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204607</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>DECITABINE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181010</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.</IndicationAndUsage>
    <Description>Decitabine is nucleoside metabolic inhibitor. Decitabine is a fine, white to almost white powder with the molecular formula of C 8H 12N 4O 4 and a molecular weight of 228.21. Its chemical name is 4-amino-1-(2-deoxy-β-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1 H)-one and it has the following structural formula:. Decitabine is slightly soluble in ethanol/water (50/50), methanol/water (50/50) and methanol; sparingly soluble in water and soluble in dimethylsulfoxide (DMSO). Decitabine for injection (decitabine), for a intravenous use, is a sterile white to almost white, lyophilized powder supplied in a clear colorless glass single-dose vial. Each 20 mL vial contains 50 mg decitabine, 68 mg monobasic potassium phosphate (potassium dihydrogen phosphate) and 11.6 mg sodium hydroxide. Sodium hydroxide and /or hydrochloric acid are used for pH adjustment.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-317-25</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (67457-317-25)  &gt; 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>67457-0317-25</NDC11Code>
    <ProductNDC>67457-317</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Palonosetron Hydrochloride</ProprietaryName>
    <NonProprietaryName>Palonosetron Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180920</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206416</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>PALONOSETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-08-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180920</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Palonosetron hydrochloride injection is indicated in adults for prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)., 2 acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC)., 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.</IndicationAndUsage>
    <Description>Palonosetron hydrochloride injection contains palonosetron as palonosetron hydrochloride, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(s)-1-azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1H-benzo[de]isoquinoline hydrochloride. The molecular formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Palonosetron hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron hydrochloride injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron hydrochloride injection is available as a 5 mL single-dose vial. Each 5 mL vial contains: 0.25 mg palonosetron (equivalent to 0.28 mg palonosetron hydrochloride), 207.5 mg mannitol, disodium edetate and citrate buffer in water for intravenous administration. The pH of the solution in the 5 mL vial is 4.5 to 5.5. Hydrochloric acid or sodium hydroxide may have been added to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-323-25</NDCCode>
    <PackageDescription>1 BAG in 1 CARTON (67457-323-25)  / 250 mL in 1 BAG</PackageDescription>
    <NDC11Code>67457-0323-25</NDC11Code>
    <ProductNDC>67457-323</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Moxifloxacin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Moxifloxacin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20171003</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205833</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>MOXIFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/250mL</StrengthUnit>
    <Pharm_Classes>Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171003</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Moxifloxacin is a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below: 1 Community Acquired Pneumonia (1.1), 2 Skin and Skin Structure Infections: Uncomplicated (1.2) and Complicated (1.3), 3 Complicated Intra-Abdominal Infections (1.4) , 4 Plague (1.5), 5 Acute Bacterial Sinusitis (1.6), 6 Acute Bacterial Exacerbation of Chronic Bronchitis (1.7) .</IndicationAndUsage>
    <Description>Moxifloxacin hydrochloride in sodium chloride injection is a synthetic antibacterial agent for intravenous administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a light yellow or yellow powder or crystals with a molecular weight of 437.89. Its empirical formula is C21H24FN3O4 · HCl and its chemical structure is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-353-10</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (67457-353-10)  &gt; 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (67457-353-25) </PackageDescription>
    <NDC11Code>67457-0353-10</NDC11Code>
    <ProductNDC>67457-353</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ampicillin</ProprietaryName>
    <NonProprietaryName>Ampicillin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20161006</StartMarketingDate>
    <EndMarketingDate>20220430</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201025</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>AMPICILLIN SODIUM</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-05-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20161006</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67457-353-25</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (67457-353-25)  &gt; 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
    <NDC11Code>67457-0353-25</NDC11Code>
    <ProductNDC>67457-353</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ampicillin</ProprietaryName>
    <NonProprietaryName>Ampicillin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20140410</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201025</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>AMPICILLIN SODIUM</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>67457-357-25</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (67457-357-25)  &gt; 25 mL in 1 VIAL</PackageDescription>
    <NDC11Code>67457-0357-25</NDC11Code>
    <ProductNDC>67457-357</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Epirubicin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Epirubicin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20130731</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091599</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>EPIRUBICIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/25mL</StrengthUnit>
    <Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-26</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>67457-372-99</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (67457-372-99)  / 1 mL in 1 VIAL, SINGLE-DOSE (67457-372-12) </PackageDescription>
    <NDC11Code>67457-0372-99</NDC11Code>
    <ProductNDC>67457-372</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Heparin Sodium</ProprietaryName>
    <NonProprietaryName>Heparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20180525</StartMarketingDate>
    <EndMarketingDate>20260731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203851</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>HEPARIN SODIUM</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>[USP'U]/mL</StrengthUnit>
    <Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180525</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Heparin sodium injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism; , 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; , 3 Atrial fibrillation with embolization; , 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); , 5 Prevention of clotting in arterial and cardiac surgery; , 6 Prophylaxis and treatment of peripheral arterial embolism. , 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .</IndicationAndUsage>
    <Description>Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of heparin sodium, USP (representative subunits):. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium Injection, USP preserved with Benzyl Alcohol is available in the following concentrations/mL:. pH 5.0 to 7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-373-99</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (67457-373-99)  / 1 mL in 1 VIAL (67457-373-12) </PackageDescription>
    <NDC11Code>67457-0373-99</NDC11Code>
    <ProductNDC>67457-373</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Heparin Sodium</ProprietaryName>
    <NonProprietaryName>Heparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20180614</StartMarketingDate>
    <EndMarketingDate>20250731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203852</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>HEPARIN SODIUM</SubstanceName>
    <StrengthNumber>20000</StrengthNumber>
    <StrengthUnit>[USP'U]/mL</StrengthUnit>
    <Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180614</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Heparin sodium injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism; , 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; , 3 Atrial fibrillation with embolization; , 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); , 5 Prevention of clotting in arterial and cardiac surgery; , 6 Prophylaxis and treatment of peripheral arterial embolism. , 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .</IndicationAndUsage>
    <Description>Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose 6-sulfate, (3) ß-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)&gt; (1)&gt; (4)&gt; (3)&gt; (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. Heparin sodium injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity, in water for injection. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of heparin sodium (representative subunits). Heparin sodium injection, USP (porcine), preserved with parabens, is available as follows:. Each mL of the 20,000 units per mL preparation contains: 20,000 USP heparin units (porcine); 1.5 mg methylparaben; 0.15 mg propylparaben; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Each mL of heparin sodium injection contains 15 mg of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-374-99</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (67457-374-99)  / 1 mL in 1 VIAL, SINGLE-DOSE (67457-374-12) </PackageDescription>
    <NDC11Code>67457-0374-99</NDC11Code>
    <ProductNDC>67457-374</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Heparin Sodium</ProprietaryName>
    <NonProprietaryName>Heparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20180316</StartMarketingDate>
    <EndMarketingDate>20260731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203851</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>HEPARIN SODIUM</SubstanceName>
    <StrengthNumber>5000</StrengthNumber>
    <StrengthUnit>[USP'U]/mL</StrengthUnit>
    <Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180316</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Heparin sodium injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism; , 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; , 3 Atrial fibrillation with embolization; , 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); , 5 Prevention of clotting in arterial and cardiac surgery; , 6 Prophylaxis and treatment of peripheral arterial embolism. , 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .</IndicationAndUsage>
    <Description>Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of heparin sodium, USP (representative subunits):. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium Injection, USP preserved with Benzyl Alcohol is available in the following concentrations/mL:. pH 5.0 to 7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-379-25</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (67457-379-25)  &gt; 1 mL in 1 VIAL, SINGLE-DOSE (67457-379-12) </PackageDescription>
    <NDC11Code>67457-0379-25</NDC11Code>
    <ProductNDC>67457-379</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paricalcitol</ProprietaryName>
    <NonProprietaryName>Paricalcitol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181221</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203897</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>PARICALCITOL</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Ergocalciferols [CS], Vitamin D2 Analog [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paricalcitol injection is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis.</IndicationAndUsage>
    <Description>Paricalcitol, USP, is a synthetically manufactured active vitamin D analog. It is a white to almost white crystalline powder chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula. Molecular formula is C27H44O3. Molecular weight is 416.64. Paricalcitol injection, USP is a sterile, clear, colorless, aqueous solution for intravenous use. Each mL contains paricalcitol, 2 mcg or 5 mcg and the following inactive ingredients: alcohol, 20% (v/v) and propylene glycol, 30% (v/v).</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-380-25</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (67457-380-25)  &gt; 1 mL in 1 VIAL, SINGLE-DOSE (67457-380-12) </PackageDescription>
    <NDC11Code>67457-0380-25</NDC11Code>
    <ProductNDC>67457-380</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paricalcitol</ProprietaryName>
    <NonProprietaryName>Paricalcitol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181221</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203897</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>PARICALCITOL</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Ergocalciferols [CS], Vitamin D2 Analog [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paricalcitol injection is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis.</IndicationAndUsage>
    <Description>Paricalcitol, USP, is a synthetically manufactured active vitamin D analog. It is a white to almost white crystalline powder chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula. Molecular formula is C27H44O3. Molecular weight is 416.64. Paricalcitol injection, USP is a sterile, clear, colorless, aqueous solution for intravenous use. Each mL contains paricalcitol, 2 mcg or 5 mcg and the following inactive ingredients: alcohol, 20% (v/v) and propylene glycol, 30% (v/v).</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-383-99</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (67457-383-99)  / 10 mL in 1 VIAL, MULTI-DOSE (67457-383-10) </PackageDescription>
    <NDC11Code>67457-0383-99</NDC11Code>
    <ProductNDC>67457-383</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Heparin Sodium</ProprietaryName>
    <NonProprietaryName>Heparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20180614</StartMarketingDate>
    <EndMarketingDate>20260731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203851</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>HEPARIN SODIUM</SubstanceName>
    <StrengthNumber>5000</StrengthNumber>
    <StrengthUnit>[USP'U]/mL</StrengthUnit>
    <Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180614</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Heparin sodium injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism; , 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; , 3 Atrial fibrillation with embolization; , 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); , 5 Prevention of clotting in arterial and cardiac surgery; , 6 Prophylaxis and treatment of peripheral arterial embolism. , 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .</IndicationAndUsage>
    <Description>Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of heparin sodium, USP (representative subunits):. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium Injection, USP preserved with Benzyl Alcohol is available in the following concentrations/mL:. pH 5.0 to 7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-384-99</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (67457-384-99)  / 30 mL in 1 VIAL, MULTI-DOSE (67457-384-31) </PackageDescription>
    <NDC11Code>67457-0384-99</NDC11Code>
    <ProductNDC>67457-384</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Heparin Sodium</ProprietaryName>
    <NonProprietaryName>Heparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20180316</StartMarketingDate>
    <EndMarketingDate>20260930</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203851</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>HEPARIN SODIUM</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>[USP'U]/mL</StrengthUnit>
    <Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180316</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Heparin sodium injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism; , 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; , 3 Atrial fibrillation with embolization; , 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); , 5 Prevention of clotting in arterial and cardiac surgery; , 6 Prophylaxis and treatment of peripheral arterial embolism. , 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .</IndicationAndUsage>
    <Description>Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of heparin sodium, USP (representative subunits):. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium Injection, USP preserved with Benzyl Alcohol is available in the following concentrations/mL:. pH 5.0 to 7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-385-99</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (67457-385-99)  / 10 mL in 1 VIAL, MULTI-DOSE (67457-385-10) </PackageDescription>
    <NDC11Code>67457-0385-99</NDC11Code>
    <ProductNDC>67457-385</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Heparin Sodium</ProprietaryName>
    <NonProprietaryName>Heparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20180316</StartMarketingDate>
    <EndMarketingDate>20260731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203851</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>HEPARIN SODIUM</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>[USP'U]/mL</StrengthUnit>
    <Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180316</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Heparin sodium injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism; , 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; , 3 Atrial fibrillation with embolization; , 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); , 5 Prevention of clotting in arterial and cardiac surgery; , 6 Prophylaxis and treatment of peripheral arterial embolism. , 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .</IndicationAndUsage>
    <Description>Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of heparin sodium, USP (representative subunits):. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium Injection, USP preserved with Benzyl Alcohol is available in the following concentrations/mL:. pH 5.0 to 7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-389-25</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (67457-389-25)  &gt; 2 mL in 1 VIAL, SINGLE-DOSE (67457-389-22) </PackageDescription>
    <NDC11Code>67457-0389-25</NDC11Code>
    <ProductNDC>67457-389</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paricalcitol</ProprietaryName>
    <NonProprietaryName>Paricalcitol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181221</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203897</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>PARICALCITOL</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Ergocalciferols [CS], Vitamin D2 Analog [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paricalcitol injection is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis.</IndicationAndUsage>
    <Description>Paricalcitol, USP, is a synthetically manufactured active vitamin D analog. It is a white to almost white crystalline powder chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula. Molecular formula is C27H44O3. Molecular weight is 416.64. Paricalcitol injection, USP is a sterile, clear, colorless, aqueous solution for intravenous use. Each mL contains paricalcitol, 2 mcg or 5 mcg and the following inactive ingredients: alcohol, 20% (v/v) and propylene glycol, 30% (v/v).</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-395-25</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (67457-395-25)  &gt; 25 mL in 1 VIAL</PackageDescription>
    <NDC11Code>67457-0395-25</NDC11Code>
    <ProductNDC>67457-395</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxorubicin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Doxorubicin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20120214</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200901</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>DOXORUBICIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/25mL</StrengthUnit>
    <Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-15</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>67457-399-25</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (67457-399-25)  / 10 mL in 1 VIAL, MULTI-DOSE (67457-399-10) </PackageDescription>
    <NDC11Code>67457-0399-25</NDC11Code>
    <ProductNDC>67457-399</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyanocobalamine</ProprietaryName>
    <NonProprietaryName>Cyanocobalamine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20170706</StartMarketingDate>
    <EndMarketingDate>20250630</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204829</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>CYANOCOBALAMIN</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Vitamin B 12 [CS], Vitamin B12 [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170706</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions: 1 Addisonian (pernicious) anemia, 2 Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy, 3 Fish tapeworm infestation, 4 Malignancy of pancreas or bowel, 5 Folic acid deficiency.</IndicationAndUsage>
    <Description>Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin, Sodium Chloride 0.9%. Benzyl Alcohol 1.5%, is present as a preservative. Sodium acetate and Glacial acetic acid are present as buffers. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5 to 7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder or purplish crystalline powder. Sparingly soluble in water and soluble in alcohol, practically insoluble in acetone, in chloroform and in ether. It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.4. The structural formula is represented below.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-418-05</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (67457-418-05)  / 5 mL in 1 VIAL (67457-418-00) </PackageDescription>
    <NDC11Code>67457-0418-05</NDC11Code>
    <ProductNDC>67457-418</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
    <NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE</RouteName>
    <StartMarketingDate>20200415</StartMarketingDate>
    <EndMarketingDate>20261031</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040803</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200415</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>A. By intravenous or intramuscular injection when oral therapy is not feasible. 1. Endocrine disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute and subacute bursitis. Epicondylitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Psoriatic arthritis. Ankylosing spondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Acute rheumatic carditis. 4. Dermatologic Diseases. Pemphigus. Severe erythema multiforme. (Stevens-Johnson Syndrome). Exfoliative dermatitis. Bullous dermatitis herpetiformis. Severe seborrheic dermatitis. Severe psoriasis. Mycosis fungoides. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Seasonal or perennial allergic rhinitis. Drug hypersensitivity reactions. Urticarial transfusion reactions. Acute noninfectious laryngeal edema (epinephrine is the drug of first choice). 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye, such as. Herpes zoster ophthalmicus. Iritis, iridocyclitis. Chorioretinitis. Diffuse posterior uveitis and choroiditis. Optic neuritis. Sympathetic ophthalmia. Anterior segment inflammation. Allergic conjunctivitis. Keratitis. Allergic corneal marginal ulcers. 7. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis (systemic therapy). Regional enteritis (systemic therapy). 8. Respiratory Diseases. Symptomatic sarcoidosis. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Loeffler's syndrome not manageable by other means. Aspiration pneumonitis. 9. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia. Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated). Secondary thrombocytopenia in adults. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 10. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 11. Edematous States. To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 12. Miscellaneous.  Tuberculosis meningitis with subarachnoid block or impending block when used concurrently   with appropriate antituberculous chemotherapy.  Trichinosis with neurologic or myocardial involvement. 13.  Diagnostic testing of adrenocortical hyperfunction. 14.  Cerebral Edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Use in cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy. B. By intra-articular or soft tissue injection. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Synovitis of osteoarthritis. Rheumatoid arthritis. Acute and subacute bursitis. Acute gouty arthritis. Epicondylitis. Acute nonspecific tenosynovitis. Post-traumatic osteoarthritis. C. By intralesional injection. Keloids. Localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis). Discoid lupus erythematosus. Necrobiosis lipoidica diabeticorum. Alopecia areata. May also be useful in cystic tumors of an aponeurosis or tendon (ganglia).</IndicationAndUsage>
    <Description>Dexamethasone sodium phosphate, a synthetic adrenocortical steroid, is a white or slightly yellow, crystalline powder. It is freely soluble in water and is exceedingly hygroscopic. The molecular weight is 516.41. It is designated chemically as 9-fluoro-11β,17-dihydroxy-16α-methyl-21-(phosphonooxy)pregna-1,4-diene-3,20-dione disodium salt. The empirical formula is C22H28FNa2O8P and the structural formula is. Dexamethasone sodium phosphate injection, USP is a sterile solution of dexamethasone sodium phosphate, and is supplied in 4 mg/ mL and 10 mg /mL. Dexamethasone sodium phosphate injection, USP 4 mg/mL is a sterile solution for intravenous, intramuscular, intra-articular, intralesional and soft tissue administration. Each mL contains:. Active: Dexamethasone sodium phosphate 4.4 mg (equivalent to dexamethasone phosphate 4 mg). Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg. Inactives: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for Injection q.s to 1 mL. Dexamethasone sodium phosphate injection, USP 10 mg/mL is a sterile solution for intravenous or intramuscular use only. Each mL contains:. Actives: Dexamethasone sodium phosphate 11 mg (equivalent to dexamethasone phosphate 10 mg). Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg. Inactives: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for Injection q.s to 1 mL.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-419-01</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (67457-419-01)  / 1 mL in 1 VIAL (67457-419-00) </PackageDescription>
    <NDC11Code>67457-0419-01</NDC11Code>
    <ProductNDC>67457-419</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
    <NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE</RouteName>
    <StartMarketingDate>20200415</StartMarketingDate>
    <EndMarketingDate>20260930</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040803</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200415</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>A. By intravenous or intramuscular injection when oral therapy is not feasible. 1. Endocrine disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute and subacute bursitis. Epicondylitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Psoriatic arthritis. Ankylosing spondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Acute rheumatic carditis. 4. Dermatologic Diseases. Pemphigus. Severe erythema multiforme. (Stevens-Johnson Syndrome). Exfoliative dermatitis. Bullous dermatitis herpetiformis. Severe seborrheic dermatitis. Severe psoriasis. Mycosis fungoides. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Seasonal or perennial allergic rhinitis. Drug hypersensitivity reactions. Urticarial transfusion reactions. Acute noninfectious laryngeal edema (epinephrine is the drug of first choice). 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye, such as. Herpes zoster ophthalmicus. Iritis, iridocyclitis. Chorioretinitis. Diffuse posterior uveitis and choroiditis. Optic neuritis. Sympathetic ophthalmia. Anterior segment inflammation. Allergic conjunctivitis. Keratitis. Allergic corneal marginal ulcers. 7. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis (systemic therapy). Regional enteritis (systemic therapy). 8. Respiratory Diseases. Symptomatic sarcoidosis. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Loeffler's syndrome not manageable by other means. Aspiration pneumonitis. 9. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia. Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated). Secondary thrombocytopenia in adults. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 10. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 11. Edematous States. To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 12. Miscellaneous.  Tuberculosis meningitis with subarachnoid block or impending block when used concurrently   with appropriate antituberculous chemotherapy.  Trichinosis with neurologic or myocardial involvement. 13.  Diagnostic testing of adrenocortical hyperfunction. 14.  Cerebral Edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Use in cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy. B. By intra-articular or soft tissue injection. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Synovitis of osteoarthritis. Rheumatoid arthritis. Acute and subacute bursitis. Acute gouty arthritis. Epicondylitis. Acute nonspecific tenosynovitis. Post-traumatic osteoarthritis. C. By intralesional injection. Keloids. Localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis). Discoid lupus erythematosus. Necrobiosis lipoidica diabeticorum. Alopecia areata. May also be useful in cystic tumors of an aponeurosis or tendon (ganglia).</IndicationAndUsage>
    <Description>Dexamethasone sodium phosphate, a synthetic adrenocortical steroid, is a white or slightly yellow, crystalline powder. It is freely soluble in water and is exceedingly hygroscopic. The molecular weight is 516.41. It is designated chemically as 9-fluoro-11β,17-dihydroxy-16α-methyl-21-(phosphonooxy)pregna-1,4-diene-3,20-dione disodium salt. The empirical formula is C22H28FNa2O8P and the structural formula is. Dexamethasone sodium phosphate injection, USP is a sterile solution of dexamethasone sodium phosphate, and is supplied in 4 mg/ mL and 10 mg /mL. Dexamethasone sodium phosphate injection, USP 4 mg/mL is a sterile solution for intravenous, intramuscular, intra-articular, intralesional and soft tissue administration. Each mL contains:. Active: Dexamethasone sodium phosphate 4.4 mg (equivalent to dexamethasone phosphate 4 mg). Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg. Inactives: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for Injection q.s to 1 mL. Dexamethasone sodium phosphate injection, USP 10 mg/mL is a sterile solution for intravenous or intramuscular use only. Each mL contains:. Actives: Dexamethasone sodium phosphate 11 mg (equivalent to dexamethasone phosphate 10 mg). Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg. Inactives: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for Injection q.s to 1 mL.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-421-30</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (67457-421-30)  / 30 mL in 1 VIAL (67457-421-00) </PackageDescription>
    <NDC11Code>67457-0421-30</NDC11Code>
    <ProductNDC>67457-421</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
    <NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE</RouteName>
    <StartMarketingDate>20110511</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040803</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110511</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1. Endocrine disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute and subacute bursitis. Epicondylitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Psoriatic arthritis. Ankylosing spondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Acute rheumatic carditis. 4. Dermatologic Diseases. Pemphigus. Severe erythema multiforme. (Stevens-Johnson Syndrome). Exfoliative dermatitis. Bullous dermatitis herpetiformis. Severe seborrheic dermatitis. Severe psoriasis. Mycosis fungoides. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Seasonal or perennial allergic rhinitis. Drug hypersensitivity reactions. Urticarial transfusion reactions. Acute noninfectious laryngeal edema (epinephrine is the drug of first choice). 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye, such as. Herpes zoster ophthalmicus. Iritis, iridocyclitis. Chorioretinitis. Diffuse posterior uveitis and choroiditis. Optic neuritis. Sympathetic ophthalmia. Anterior segment inflammation. Allergic conjunctivitis. Keratitis. Allergic corneal marginal ulcers. 7. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis (systemic therapy). Regional enteritis (systemic therapy). 8. Respiratory Diseases. Symptomatic sarcoidosis. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Loeffler's syndrome not manageable by other means. Aspiration pneumonitis. 9. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia. Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated). Secondary thrombocytopenia in adults. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 10. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 11. Edematous States. To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 12. Miscellaneous. Tuberculosis meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement. 13. Diagnostic testing of adrenocortical hyperfunction. 14. Cerebral Edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Use in cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy.</IndicationAndUsage>
    <Description>Dexamethasone sodium phosphate, a synthetic adrenocortical steroid, is a white or slightly yellow, crystalline powder. It is freely soluble in water and is exceedingly hygroscopic. The molecular weight is 516.41. It is designated chemically as 9-fluoro-11β,17-dihydroxy-16α-methyl-21-(phosphonooxy)pregna-1,4-diene-3,20-dione disodium salt. The empirical formula is C22H28FNa2O8P and the structural formula is. Dexamethasone sodium phosphate injection, USP is a sterile solution of dexamethasone sodium phosphate, and is supplied in 4 mg/ mL and 10 mg /mL. Dexamethasone sodium phosphate injection, USP 4 mg/mL is a sterile solution for intravenous, intramuscular, intra-articular, intralesional and soft tissue administration. Each mL contains:. Active: Dexamethasone sodium phosphate 4.4 mg (equivalent to dexamethasone phosphate 4 mg). Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg. Inactives: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for Injection q.s to 1 mL. Dexamethasone sodium phosphate injection, USP 10 mg/mL is a sterile solution for intravenous or intramuscular use only. Each mL contains:. Actives: Dexamethasone sodium phosphate 11 mg (equivalent to dexamethasone phosphate 10 mg). Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg. Inactives: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for Injection q.s to 1 mL.</Description>
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    <RouteName>INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE</RouteName>
    <StartMarketingDate>20110511</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040803</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
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    <LastUpdate>2024-03-20</LastUpdate>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1. Endocrine disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute and subacute bursitis. Epicondylitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Psoriatic arthritis. Ankylosing spondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Acute rheumatic carditis. 4. Dermatologic Diseases. Pemphigus. Severe erythema multiforme. (Stevens-Johnson Syndrome). Exfoliative dermatitis. Bullous dermatitis herpetiformis. Severe seborrheic dermatitis. Severe psoriasis. Mycosis fungoides. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Seasonal or perennial allergic rhinitis. Drug hypersensitivity reactions. Urticarial transfusion reactions. Acute noninfectious laryngeal edema (epinephrine is the drug of first choice). 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye, such as. Herpes zoster ophthalmicus. Iritis, iridocyclitis. Chorioretinitis. Diffuse posterior uveitis and choroiditis. Optic neuritis. Sympathetic ophthalmia. Anterior segment inflammation. Allergic conjunctivitis. Keratitis. Allergic corneal marginal ulcers. 7. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis (systemic therapy). Regional enteritis (systemic therapy). 8. Respiratory Diseases. Symptomatic sarcoidosis. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Loeffler's syndrome not manageable by other means. Aspiration pneumonitis. 9. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia. Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated). Secondary thrombocytopenia in adults. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 10. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 11. Edematous States. To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 12. Miscellaneous. Tuberculosis meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement. 13. Diagnostic testing of adrenocortical hyperfunction. 14. Cerebral Edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Use in cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy.</IndicationAndUsage>
    <Description>Dexamethasone sodium phosphate, a synthetic adrenocortical steroid, is a white or slightly yellow, crystalline powder. It is freely soluble in water and is exceedingly hygroscopic. The molecular weight is 516.41. It is designated chemically as 9-fluoro-11β,17-dihydroxy-16α-methyl-21-(phosphonooxy)pregna-1,4-diene-3,20-dione disodium salt. The empirical formula is C22H28FNa2O8P and the structural formula is. Dexamethasone sodium phosphate injection, USP is a sterile solution of dexamethasone sodium phosphate, and is supplied in 4 mg/ mL and 10 mg /mL. Dexamethasone sodium phosphate injection, USP 4 mg/mL is a sterile solution for intravenous, intramuscular, intra-articular, intralesional and soft tissue administration. Each mL contains:. Active: Dexamethasone sodium phosphate 4.4 mg (equivalent to dexamethasone phosphate 4 mg). Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg. Inactives: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for Injection q.s to 1 mL. Dexamethasone sodium phosphate injection, USP 10 mg/mL is a sterile solution for intravenous or intramuscular use only. Each mL contains:. Actives: Dexamethasone sodium phosphate 11 mg (equivalent to dexamethasone phosphate 10 mg). Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg. Inactives: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for Injection q.s to 1 mL.</Description>
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