RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>65219-695-05</NDCCode>
    <PackageDescription>10 VIAL in 1 TRAY (65219-695-05)  / 5 mL in 1 VIAL (65219-695-01) </PackageDescription>
    <NDC11Code>65219-0695-05</NDC11Code>
    <ProductNDC>65219-695</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rocuronium</ProprietaryName>
    <NonProprietaryName>Rocuronium Bromide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20231011</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA217472</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ROCURONIUM BROMIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231011</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rocuronium Bromide Injection is indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
    <Description>Rocuronium bromide is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2-propenyl) pyrrolidinium bromide. The structural formula is:. Rocuronium bromide USP is an almost white to pale yellow, hygroscopic powder. Rocuronium bromide is soluble in water and dichloromethane, slightly soluble in ethanol and methanol. The chemical formula is C32H53BrN2O4 with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium Bromide Injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous use only. Each mL contains 10 mg rocuronium bromide (equivalent to 8.69 mg of rocuronium) and inactive ingredients 17.1 mcL hydrochloric acid, 8 mg sodium chloride. The solution pH is adjusted to 2.8 to 3.2 with hydrochloric acid and/or sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-695-05</NDCCode>
    <PackageDescription>50 TABLET, FILM COATED in 1 BOTTLE (16571-695-05) </PackageDescription>
    <NDC11Code>16571-0695-05</NDC11Code>
    <ProductNDC>16571-695</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azithromycin</ProprietaryName>
    <NonProprietaryName>Azithromycin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180705</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207370</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-09-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180705</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55111-695-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (55111-695-05)</PackageDescription>
    <NDC11Code>55111-0695-05</NDC11Code>
    <ProductNDC>55111-695</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glyburide And Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Glyburide And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090630</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079009</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>GLYBURIDE; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1.25; 250</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Glyburide and Metformin Hydrochloride Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Glyburide and Metformin Hydrochloride Tablets contains two oral antihyperglycemic drugs used in the management of type 2 diabetes, glyburide and metformin hydrochloride. Glyburide is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glyburide is 1-[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide is a white to off-white crystalline compound with a molecular formula of C23H28ClN3O5S and a molecular weight of 494.01. Micronized Glyburide is used in Glyburide and Metformin Hydrochloride Tablets. The structural formula is represented below. Metformin hydrochloride is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide monohydrochloride) is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or α-glucosidase inhibitors. It is a white to off-white crystalline compound with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is as shown :. Glyburide and Metformin Hydrochloride Tablets is available for oral administration in tablets containing 1.25 mg glyburide with 250 mg metformin hydrochloride, 2.5 mg glyburide with 500 mg metformin hydrochloride, and 5 mg glyburide with 500 mg metformin hydrochloride. In addition, each tablet contains the following inactive ingredients: Sodium Starch Glycolate, Povidone, Colloidal Silicon Dioxide, Magnesium Stearate. The 1.25 mg/250 mg tablet contains Opadry Yellow which containsHypromellose, Talc, Titanium Dioxide, Macrogol/PEG 6000, Propylene Glycol and Iron Oxide Yellow. The tablets are film coated, which provides color differentiation. Additionally 2.5 mg/500 mg tablet contains Opadry Pink which contains Hypromellose, Talc, Titanium Dioxide, Macrogol/PEG 6000, Propylene Glycol, Iron Oxide Yellow and Iron Oxide Red. The 5 mg/500 mg tablet contains Opadry Yellow which contains Hypromellose, Talc, Titanium Dioxide, Macrogol/PEG 6000, Propylene Glycol, Iron Oxide Yellow and D &amp; C Yellow #10 Aluminium Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-695-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (63304-695-05)</PackageDescription>
    <NDC11Code>63304-0695-05</NDC11Code>
    <ProductNDC>63304-695</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20001222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065062</ApplicationNumber>
    <LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydia psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Calymmatobacterium granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, 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>Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis (dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is:. C23H27N3O7HCl M.W. 493.95. Each minocycline hydrochloride capsule, USP for oral administration, contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>65841-695-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (65841-695-05) </PackageDescription>
    <NDC11Code>65841-0695-05</NDC11Code>
    <ProductNDC>65841-695</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tamsulosin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100427</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078225</ApplicationNumber>
    <LabelerName>Zydus Lifesciences Limited</LabelerName>
    <SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100427</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65862-695-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (65862-695-05) </PackageDescription>
    <NDC11Code>65862-0695-05</NDC11Code>
    <ProductNDC>65862-695</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metronidazole</ProprietaryName>
    <NonProprietaryName>Metronidazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150529</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203974</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>METRONIDAZOLE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis. Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablets therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets 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 tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula:. Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole USP. Inactive ingredients include colloidal silicon dioxide, hydroxypropyl cellulose, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate, and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>68428-695-05</NDCCode>
    <PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-695-05) </PackageDescription>
    <NDC11Code>68428-0695-05</NDC11Code>
    <ProductNDC>68428-695</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Venus Mercenaria</ProprietaryName>
    <NonProprietaryName>Northern Quahog</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110315</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>NORTHERN QUAHOG</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110315</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71052-695-05</NDCCode>
    <PackageDescription>.5 g in 1 PACKAGE (71052-695-05) </PackageDescription>
    <NDC11Code>71052-0695-05</NDC11Code>
    <ProductNDC>71052-695</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Semaglutide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20230425</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>DARMERICA, LLC</LabelerName>
    <SubstanceName>SEMAGLUTIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-03-12</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>25-APR-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>65219-027-50</NDCCode>
    <PackageDescription>25 VIAL, GLASS in 1 TRAY (65219-027-50)  / 50 mL in 1 VIAL, GLASS (65219-027-05) </PackageDescription>
    <NDC11Code>65219-0027-50</NDC11Code>
    <ProductNDC>65219-027</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ascorbic Acid</ProprietaryName>
    <NonProprietaryName>Ascorbic Acid</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20251208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217131</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ASCORBIC ACID</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Ascorbic Acid [CS], Vitamin C [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ascorbic acid injection is indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients, age 5 months and older, for whom oral administration is not possible, insufficient or contraindicated.  Limitations of Use.  Ascorbic acid injection is not indicated for the treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy.</IndicationAndUsage>
    <Description>Ascorbic acid injection, USP for intravenous use is a colorless to pale yellow, preservative-free, hypertonic, sterile, non-pyrogenic solution of ascorbic acid. Ascorbic acid injection must be diluted with an appropriate infusion solution (e.g., 5% Dextrose Injection, USP; Sterile Water for Injection, USP) [see Dosage and Administration (2.1)]. The chemical name of ascorbic acid, USP is L-ascorbic acid. The molecular formula is C6H8O6. It has the following structural formula. Each ascorbic acid injection, USP, 50 mL, Pharmacy Bulk Package vial that contains 25,000 mg ascorbic acid, equivalent to 28,125 mg sodium ascorbate. Each mL of ascorbic acid injection, USP contains 500 mg of ascorbic acid (equivalent to 562.5 mg of sodium ascorbate which amounts to 65 mg sodium/mL of ascorbic acid injection), 130 mg of sodium bicarbonate 0.28 mg of edetate disodium (dihydrate). Sodium hydroxide is added for pH adjustment (pH range 5.6 to 6.6). It contains no bacteriostatic or antimicrobial agent.</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-028-05</NDCCode>
    <PackageDescription>1 SYRINGE, GLASS in 1 CARTON (65219-028-05)  / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>65219-0028-05</NDC11Code>
    <ProductNDC>65219-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ganirelix Acetate</ProprietaryName>
    <NonProprietaryName>Ganirelix Acetate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20230324</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215658</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>GANIRELIX ACETATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Pharm_Classes>Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230324</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.</IndicationAndUsage>
    <Description>Ganirelix Acetate Injection is a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH). Ganirelix Acetate is derived from native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, 8, and 10 to form the following molecular formula of the peptide: N-acetyl-3-(2-naphthyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridyl)-D-alanyl-L-seryl-L-tyrosyl-N9,N10-diethyl-D-homoarginyl-L-leucyl-N9,N10-diethyl-L-homoarginyl-L-prolyl-D-alanylamide acetate. The molecular weight for Ganirelix Acetate is 1570.4 as an anhydrous free base. The structural formula is as follows:. Ganirelix Acetate. Ganirelix Acetate Injection is supplied as a colorless, sterile, ready-to-use, aqueous solution intended for SUBCUTANEOUS administration only. Each single dose, sterile, prefilled syringe contains 250 mcg/0.5 mL of Ganirelix Acetate, 0.1 mg glacial acetic acid, 23.5 mg mannitol, and water for injection adjusted to pH 5.0 with acetic acid, NF and/or sodium hydroxide, NF.</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-065-05</NDCCode>
    <PackageDescription>10 VIAL in 1 TRAY (65219-065-05)  &gt; 5 mL in 1 VIAL (65219-065-02) </PackageDescription>
    <NDC11Code>65219-0065-05</NDC11Code>
    <ProductNDC>65219-065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rocuronium</ProprietaryName>
    <NonProprietaryName>Rocuronium Bromide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220307</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078651</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ROCURONIUM BROMIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-03-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220307</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rocuronium Bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
    <Description>Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration.  Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3 α-hydroxy-2β-(4-morpholinyl)-5 α-androstan-16β-yl]-1-(2-propenyl)pyrrolidinium bromide. The structural formula is. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide Injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous injection only.  Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate.  The aqueous solution is adjusted to isotonicity with sodium chloride and to a pH of 4 with acetic acid and/or sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-080-05</NDCCode>
    <PackageDescription>10 CARTON in 1 BOX (65219-080-05)  / 1 VIAL in 1 CARTON (65219-080-01)  / 5 mL in 1 VIAL</PackageDescription>
    <NDC11Code>65219-0080-05</NDC11Code>
    <ProductNDC>65219-080</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gadoterate Meglumine</ProprietaryName>
    <NonProprietaryName>Gadoterate Meglumine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220620</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215304</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>GADOTERATE MEGLUMINE</SubstanceName>
    <StrengthNumber>376.9</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220620</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.</IndicationAndUsage>
    <Description>Gadoterate Meglumine Injection, USP is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C23H42O13N5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. Gadoterate Meglumine Injection, USP is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol per mL of gadoterate meglumine. No preservative is added. Each mL of Gadoterate Meglumine Injection, USP contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. Gadoterate Meglumine Injection USP has a pH of 6.5 to 8.0. The main physiochemical properties of Gadoterate Meglumine Injection, USP are provided below. The thermodynamic stability constants for gadoterate (log Ktherm and log Kcond at pH 7.4) are 25.6 and 19.3, respectively.</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-186-05</NDCCode>
    <PackageDescription>10 VIAL in 1 TRAY (65219-186-05)  / 5 mL in 1 VIAL (65219-186-01) </PackageDescription>
    <NDC11Code>65219-0186-05</NDC11Code>
    <ProductNDC>65219-186</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketamine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ketamine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20230710</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215808</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>KETAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-04-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250418</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ketamine Hydrochloride Injection is indicated: : 1 as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. , 2 for the induction of anesthesia prior to the administration of other general anesthetic agents. , 3 as a supplement to other anesthetic agents. .</IndicationAndUsage>
    <Description>Ketamine Hydrochloride Injection, USP, for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine Hydrochloride, USP is a white crystalline powder and has a molecular formula of C13H16ClNOHCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride. The chemical structure of ketamine hydrochloride is:. It is formulated as a slightly acidic (pH 3.5-5.5) sterile solution for intravenous or intramuscular injection. Each milliliter (mL) of the multiple-dose vials contain either 10 mg ketamine base (equivalent to 11.53 mg ketamine hydrochloride) or 50 mg ketamine base (equivalent to 57.67 mg ketamine hydrochloride) or 100 mg ketamine base (equivalent to 115.33 mg ketamine hydrochloride) and not more than 0.10 mg/mL benzethonium chloride added as a preservative in water for injection. The 10 mg/mL solution has been made isotonic with 6.60 mg sodium chloride.</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-200-05</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (65219-200-05)  *  1 mL in 1 VIAL, SINGLE-DOSE (65219-205-05)  *  1.8 mL in 1 VIAL, SINGLE-DOSE (65219-202-05) </PackageDescription>
    <NDC11Code>65219-0200-05</NDC11Code>
    <ProductNDC>65219-200</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Temsirolimus</ProprietaryName>
    <NonProprietaryName>Temsirolimus</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207383</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2020-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temsirolimus injection is indicated for the treatment of advanced renal cell carcinoma.</IndicationAndUsage>
    <Description>Temsirolimus, an inhibitor of mTOR, is an antineoplastic agent. Temsirolimus is a white to off-white powder with a molecular formula of C56H87NO16 and a molecular weight of 1030.30. It is non-hygroscopic. Temsirolimus is practically insoluble in water and soluble in alcohol. It has no ionizable functional groups, and its solubility is independent of pH. The chemical name of temsirolimus is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydrox y-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c] [1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone 4'-[2,2-bis(hydroxymethyl)propionate]; or Rapamycin, 42-[3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate]. Temsirolimus injection, 25 mg/mL, is a clear, colorless to light yellow, non-aqueous, ethanolic, sterile solution. Temsirolimus injection requires two dilutions prior to intravenous infusion. Temsirolimus injection should be diluted only with the supplied DILUENT for Temsirolimus injection. DILUENT for Temsirolimus injection is a sterile, non-aqueous solution that is supplied with Temsirolimus injection, as a kit. Temsirolimus injection, 25 mg/mL:. Active ingredient: temsirolimus (25 mg/mL). Inactive ingredients: dehydrated alcohol (49.90% v/v), butylated hydroxy anisole (0.0003% w/v), butylated hydroxy toluene (0.002% w/v), propylene glycol (50.3% w/v), and anhydrous citric acid (0.0025% w/v). DILUENT for Temsirolimus injection:. Inactive ingredients: polysorbate 80 (40.0% w/v), polyethylene glycol 400 (42.8% w/v) and dehydrated alcohol (25.14% v/v). After the Temsirolimus injection vial has been diluted with DILUENT for Temsirolimus injection, in accordance with the instructions in section 2.5, the solution contains 35.04% alcohol. Temsirolimus injection and DILUENT for Temsirolimus injection are filled in clear glass vials with butyl rubber stoppers.</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-259-45</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (65219-259-45)  / 20 mL in 1 VIAL, SINGLE-USE (65219-259-05) </PackageDescription>
    <NDC11Code>65219-0259-45</NDC11Code>
    <ProductNDC>65219-259</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
    <NonProprietaryName>Piperacillin And Tazobactam</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180518</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203719</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
    <StrengthNumber>4; .5</StrengthNumber>
    <StrengthUnit>g/20mL; g/20mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180518</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-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 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 structure of tazobactam sodium is:. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Piperacillin and tazobactam for injection, USP is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. : 1 Each Piperacillin and Tazobactam for Injection 2.25 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. , 2 Each Piperacillin and Tazobactam for Injection 3.375 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. , 3 Each Piperacillin and Tazobactam for Injection 4.5 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam.</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-274-05</NDCCode>
    <PackageDescription>10 SYRINGE, PLASTIC in 1 CARTON (65219-274-05)  / 5 mL in 1 SYRINGE, PLASTIC (65219-274-01) </PackageDescription>
    <NDC11Code>65219-0274-05</NDC11Code>
    <ProductNDC>65219-274</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Succinylcholine Chloride</ProprietaryName>
    <NonProprietaryName>Succinylcholine Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20250619</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217884</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA LLC</LabelerName>
    <SubstanceName>SUCCINYLCHOLINE CHLORIDE DIHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250619</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Succinylcholine Chloride Injection is indicated in adults and pediatric patients: : 1 as an adjunct to general anesthesia , 2 to facilitate tracheal intubation , 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation .</IndicationAndUsage>
    <Description>Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short- acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine Chloride Injection contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated as Ethanaminium, 2,2'-[(1,4-dioxo-1,4- butanediyl) bis(oxy)]bis[N, N, N-trimethyl-, dichloride, dihydrate, it's molecular formula is C14H30Cl2N2O42H2O and its molecular weight is 397.34. It has the following structural formula:. Succinylcholine is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. The drug is incompatible with alkaline solutions but relatively stable in acid solutions. Solutions of the drug lose potency unless refrigerated. Succinylcholine Chloride Injection, USP 100 mg/5 mL (20 mg/mL) is intended for single-dose administration and contains no preservatives. Unused solution should be discarded. Product not requiring dilution (single-dose prefilled syringe) contains sodium chloride to render isotonic. Each milliliter contains 20 mg succinylcholine chloride USP (in anhydrous form) equivalent to 21.99 mg succinylcholine chloride USP (in dihydrate form) and 4.7 mg of sodium chloride as an isotonicity agent. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH of the solution is 3.6 (3.0 to 4.5), with an osmolarity of 0.338 mOsm/mL (calc.).</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-281-15</NDCCode>
    <PackageDescription>2 CARTON in 1 BOX (65219-281-15)  / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (65219-281-05) </PackageDescription>
    <NDC11Code>65219-0281-15</NDC11Code>
    <ProductNDC>65219-281</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gadobutrol</ProprietaryName>
    <NonProprietaryName>Gadobutrol</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230414</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215061</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>GADOBUTROL</SubstanceName>
    <StrengthNumber>604.72</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230414</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gadobutrol injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): 1 To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates (1.1), 2 To assess the presence and extent of malignant breast disease in adult patients (1.2), 3 To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates (1.3), 4 To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). (1.4).</IndicationAndUsage>
    <Description>Gadobutrol injection is a paramagnetic macrocyclic contrast agent administered for magnetic resonance imaging. The chemical name for gadobutrol is 10–[(1SR,2RS)–2,3–dihydroxy–1–hydroxymethylpropyl]–1,4,7,10–tetraazacyclododecane–1,4,7–triacetic acid, gadolinium complex. Gadobutrol has a molecular formula of C18H31GdN4O9 and a molecular weight of 604.72. Gadobutrol injection is a sterile, clear, colorless to pale yellow solution containing 604.72 mg (1.0 mmol) of gadobutrol per mL as the active ingredient with 0.513 mg of calcobutrol sodium, 1.211 mg of trometamol, hydrochloric acid (for pH adjustment) and water for injection. Gadobutrol injection contains no preservatives. The main physicochemical properties of gadobutrol injection (1 mmol/mL solution for injection) are listed below. The thermodynamic stability constants for gadobutrol (log Ktherm and log Kcond at pH 7.4) are 21.8 and 15.3, respectively.</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-381-50</NDCCode>
    <PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (65219-381-50)  / 150 mL in 1 BOTTLE, PLASTIC (65219-381-05) </PackageDescription>
    <NDC11Code>65219-0381-50</NDC11Code>
    <ProductNDC>65219-381</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iodixanol</ProprietaryName>
    <NonProprietaryName>Iodixanol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVASCULAR</RouteName>
    <StartMarketingDate>20220621</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214271</ApplicationNumber>
    <LabelerName>FRESENIUS KABI USA, LLC</LabelerName>
    <SubstanceName>IODIXANOL</SubstanceName>
    <StrengthNumber>270</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220621</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iodixanol injection is indicated in for.</IndicationAndUsage>
    <Description>Iodixanol injection, USP is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-­1,3-benzenedicarboxamide] with a molecular weight of 1,550.18 (iodine content 49.1%). Iodixanol (C 35H 44I 6N 6O 15) has the following structural formula. Iodixanol injection, USP is available in two strengths: 1 Iodixanol Injection, USP, 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 Iodixanol Injection, USP, 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-383-05</NDCCode>
    <PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (65219-383-05)  / 50 mL in 1 BOTTLE, PLASTIC (65219-383-02) </PackageDescription>
    <NDC11Code>65219-0383-05</NDC11Code>
    <ProductNDC>65219-383</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iodixanol</ProprietaryName>
    <NonProprietaryName>Iodixanol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVASCULAR</RouteName>
    <StartMarketingDate>20220621</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214271</ApplicationNumber>
    <LabelerName>FRESENIUS KABI USA, LLC</LabelerName>
    <SubstanceName>IODIXANOL</SubstanceName>
    <StrengthNumber>320</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220621</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iodixanol injection is indicated in for.</IndicationAndUsage>
    <Description>Iodixanol injection, USP is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-­1,3-benzenedicarboxamide] with a molecular weight of 1,550.18 (iodine content 49.1%). Iodixanol (C 35H 44I 6N 6O 15) has the following structural formula. Iodixanol injection, USP is available in two strengths: 1 Iodixanol Injection, USP, 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 Iodixanol Injection, USP, 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-387-05</NDCCode>
    <PackageDescription>20 BAG in 1 CASE (65219-387-05)  &gt; 500 mL in 1 BAG (65219-387-00) </PackageDescription>
    <NDC11Code>65219-0387-05</NDC11Code>
    <ProductNDC>65219-387</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Multiple Electrolytes Ph 5.5</ProprietaryName>
    <NonProprietaryName>Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride And Magnesium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215370</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
    <StrengthNumber>526; 502; 368; 37; 30</StrengthNumber>
    <StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-11-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Multiple Electrolytes Injection, Type 1, USP, pH 5.5 is indicated as a source of water and electrolytes or as an alkalinizing agent.</IndicationAndUsage>
    <Description>Multiple Electrolytes Injection, Type 1, USP, pH 5.5 is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C6H11NaO7); 368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO23H2O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl26H2O). It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid. The pH is 5.5 (4.0 to 8.0). Multiple Electrolytes Injection, Type 1, USP, pH 5.5 administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 140 mEq sodium, 5 mEq potassium, 3 mEq magnesium, 98 mEq chloride, 27 mEq acetate, and 23 mEq gluconate. The osmolarity is 294 mOsmol/L (calc). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. The caloric content is 21 kcal/L. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-389-05</NDCCode>
    <PackageDescription>20 BAG in 1 CASE (65219-389-05)  &gt; 500 mL in 1 BAG (65219-389-00) </PackageDescription>
    <NDC11Code>65219-0389-05</NDC11Code>
    <ProductNDC>65219-389</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Multiple Electrolytes Ph 7.4</ProprietaryName>
    <NonProprietaryName>Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride And Magnesium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210617</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215371</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
    <StrengthNumber>526; 502; 368; 37; 30</StrengthNumber>
    <StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-11-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Multiple Electrolytes Injection, Type 1, USP, pH 7.4 is indicated as a source of water and electrolytes or as an alkalinizing agent.</IndicationAndUsage>
    <Description>Multiple Electrolytes Injection, Type 1, USP, pH 7.4 is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C6H11NaO7); 368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO23H2O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl26H2O). It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide. The pH is 7.4 (6.5 to 8.0). Multiple Electrolytes Injection, Type 1, USP, pH 7.4 administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 140 mEq sodium, 5 mEq potassium, 3 mEq magnesium, 98 mEq chloride, 27 mEq acetate, and 23 mEq gluconate. The osmolarity is 294 mOsmol/L (calc). Normal physiologic osmolarity range is 280 to 310 mOsmol/L. The caloric content is 21 kcal/L. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-405-05</NDCCode>
    <PackageDescription>25 VIAL in 1 TRAY (65219-405-05)  &gt; 5 mL in 1 VIAL (65219-405-02) </PackageDescription>
    <NDC11Code>65219-0405-05</NDC11Code>
    <ProductNDC>65219-405</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zinc Sulfate</ProprietaryName>
    <NonProprietaryName>Zinc Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20221227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216145</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ZINC SULFATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-01-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zinc Sulfate Injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
    <Description>Zinc Sulfate Injection, USP is a sterile, clear, colorless solution, essentially free from visible particles intended for use as a trace element and an additive to intravenous solutions for parenteral nutrition. 10 mg per 10 mL Pharmacy Bulk Package vial. Each mL contains 1 mg of zinc present as a 2.46 mg of zinc sulfate and water for injection, q.s. 30 mg per 10 mL Pharmacy Bulk Package vial. Each mL contains 3 mg of zinc present as 7.41 mg of zinc sulfate and water for injection, q.s. 25 mg per 5 mL Pharmacy Bulk Package vial. Each mL contains 5 mg of zinc present as 12.32 mg of zinc sulfate and water for injection, q.s. All presentations do not contain preservatives. The pH range is 2 to 4; pH may be adjusted with sulfuric acid. 1 mg/mL of Zinc Sulfate Injection contains no more than 1,500 mcg/L of aluminum and has a calculated osmolarity of 33 mOsmol/L. 3 mg/mL of Zinc Sulfate Injection contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 96.5 mOsmol/L. 5 mg/mL of Zinc Sulfate Injection contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 157.2 mOsmol/L. Zinc sulfate heptahydrate, USP has a molecular weight of 287.54 g/mol and a formula of ZnSO4·7H2O.</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-442-05</NDCCode>
    <PackageDescription>10 VIAL in 1 TRAY (65219-442-05)  / 5 mL in 1 VIAL (65219-442-02) </PackageDescription>
    <NDC11Code>65219-0442-05</NDC11Code>
    <ProductNDC>65219-442</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rocuronium</ProprietaryName>
    <NonProprietaryName>Rocuronium Bromide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20231011</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA217472</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ROCURONIUM BROMIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231011</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rocuronium Bromide Injection is indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
    <Description>Rocuronium bromide is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2-propenyl) pyrrolidinium bromide. The structural formula is:. Rocuronium bromide USP is an almost white to pale yellow, hygroscopic powder. Rocuronium bromide is soluble in water and dichloromethane, slightly soluble in ethanol and methanol. The chemical formula is C32H53BrN2O4 with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium Bromide Injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous use only. Each mL contains 10 mg rocuronium bromide (equivalent to 8.69 mg of rocuronium) and inactive ingredients 17.1 mcL hydrochloric acid, 8 mg sodium chloride. The solution pH is adjusted to 2.8 to 3.2 with hydrochloric acid and/or sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-456-60</NDCCode>
    <PackageDescription>60 BAG in 1 CASE (65219-456-60)  / 50 mL in 1 BAG (65219-456-05) </PackageDescription>
    <NDC11Code>65219-0456-60</NDC11Code>
    <ProductNDC>65219-456</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextrose</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240709</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207449</ApplicationNumber>
    <LabelerName>FRESENIUS KABI USA, LLC</LabelerName>
    <SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240709</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.</IndicationAndUsage>
    <Description>5% Dextrose Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose monohydrate, 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. The solution pH is 4.3 (3.2 to 6.5). This solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 5% Dextrose Injection, USP is a parenteral fluid and nutrient replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula:. Water for Injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized film containing polypropylene and thermoplastic elastomers (freeflex® bag). 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>65219-458-30</NDCCode>
    <PackageDescription>30 BAG in 1 CASE (65219-458-30)  / 250 mL in 1 BAG (65219-458-05) </PackageDescription>
    <NDC11Code>65219-0458-30</NDC11Code>
    <ProductNDC>65219-458</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextrose</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240709</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207449</ApplicationNumber>
    <LabelerName>FRESENIUS KABI USA, LLC</LabelerName>
    <SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240709</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.</IndicationAndUsage>
    <Description>5% Dextrose Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose monohydrate, 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. The solution pH is 4.3 (3.2 to 6.5). This solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 5% Dextrose Injection, USP is a parenteral fluid and nutrient replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula:. Water for Injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized film containing polypropylene and thermoplastic elastomers (freeflex® bag). 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>65219-460-20</NDCCode>
    <PackageDescription>20 BAG in 1 CASE (65219-460-20)  / 500 mL in 1 BAG (65219-460-05) </PackageDescription>
    <NDC11Code>65219-0460-20</NDC11Code>
    <ProductNDC>65219-460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextrose</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240709</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207449</ApplicationNumber>
    <LabelerName>FRESENIUS KABI USA, LLC</LabelerName>
    <SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240709</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.</IndicationAndUsage>
    <Description>5% Dextrose Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose monohydrate, 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. The solution pH is 4.3 (3.2 to 6.5). This solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 5% Dextrose Injection, USP is a parenteral fluid and nutrient replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula:. Water for Injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized film containing polypropylene and thermoplastic elastomers (freeflex® bag). 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>65219-462-10</NDCCode>
    <PackageDescription>10 BAG in 1 CASE (65219-462-10)  / 1000 mL in 1 BAG (65219-462-05) </PackageDescription>
    <NDC11Code>65219-0462-10</NDC11Code>
    <ProductNDC>65219-462</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextrose</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240709</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207449</ApplicationNumber>
    <LabelerName>FRESENIUS KABI USA, LLC</LabelerName>
    <SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240709</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.</IndicationAndUsage>
    <Description>5% Dextrose Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose monohydrate, 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. The solution pH is 4.3 (3.2 to 6.5). This solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 5% Dextrose Injection, USP is a parenteral fluid and nutrient replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula:. Water for Injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized film containing polypropylene and thermoplastic elastomers (freeflex® bag). 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>65219-464-50</NDCCode>
    <PackageDescription>50 BAG in 1 CASE (65219-464-50)  / 100 mL in 1 BAG (65219-464-05) </PackageDescription>
    <NDC11Code>65219-0464-50</NDC11Code>
    <ProductNDC>65219-464</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextrose</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240709</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207449</ApplicationNumber>
    <LabelerName>FRESENIUS KABI USA, LLC</LabelerName>
    <SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240709</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.</IndicationAndUsage>
    <Description>5% Dextrose Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose monohydrate, 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. The solution pH is 4.3 (3.2 to 6.5). This solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 5% Dextrose Injection, USP is a parenteral fluid and nutrient replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula:. Water for Injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized film containing polypropylene and thermoplastic elastomers (freeflex® bag). 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>65219-466-60</NDCCode>
    <PackageDescription>60 BAG in 1 CASE (65219-466-60)  / 50 mL in 1 BAG (65219-466-05) </PackageDescription>
    <NDC11Code>65219-0466-60</NDC11Code>
    <ProductNDC>65219-466</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170919</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207310</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170919</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.</IndicationAndUsage>
    <Description>0.9% Sodium Chloride Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing sodium chloride in water for injection intended for intravenous administration. For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes per 1,000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solution is a parenteral fluid and electrolyte replenisher. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). 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>65219-468-50</NDCCode>
    <PackageDescription>50 BAG in 1 CASE (65219-468-50)  / 100 mL in 1 BAG (65219-468-05) </PackageDescription>
    <NDC11Code>65219-0468-50</NDC11Code>
    <ProductNDC>65219-468</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170919</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207310</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170919</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.</IndicationAndUsage>
    <Description>0.9% Sodium Chloride Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing sodium chloride in water for injection intended for intravenous administration. For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes per 1,000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solution is a parenteral fluid and electrolyte replenisher. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). 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>
</NDCList>