{
"NDC": [
{
"NDCCode": "65219-020-23",
"PackageDescription": "10 VIAL in 1 CARTON (65219-020-23) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-020-03) ",
"NDC11Code": "65219-0020-23",
"ProductNDC": "65219-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20191031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062797",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "2",
"StrengthUnit": "g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2022-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191031",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by S. pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.",
"Description": "Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl) amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10."
},
{
"NDCCode": "65219-186-23",
"PackageDescription": "10 VIAL in 1 TRAY (65219-186-23) / 5 mL in 1 VIAL (65219-186-13) ",
"NDC11Code": "65219-0186-23",
"ProductNDC": "65219-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketamine Hydrochloride",
"NonProprietaryName": "Ketamine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20230710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215808",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "KETAMINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250418",
"SamplePackage": "N",
"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. .",
"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 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."
},
{
"NDCCode": "42411-020-23",
"PackageDescription": "42650 L in 1 CYLINDER (42411-020-23)",
"NDC11Code": "42411-0020-23",
"ProductNDC": "42411-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19600101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205713",
"LabelerName": "Air Liquide America Specialty Gases LLC",
"SubstanceName": "NITROGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "59779-020-23",
"PackageDescription": "113 g in 1 BOTTLE, PLASTIC (59779-020-23)",
"NDC11Code": "59779-0020-23",
"ProductNDC": "59779-020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Pharmacy Sunscreen Spf 45",
"NonProprietaryName": "Octinoxate, Octocrlyene, Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121217",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE; ZINC OXIDE",
"StrengthNumber": "7.5; 8; 6.8",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "helps prevent sunburn. higher SPF gives more sunburn protection. retains SPF after 80 minutes of activity in water."
},
{
"NDCCode": "64253-020-23",
"PackageDescription": "60 SYRINGE, PLASTIC in 1 BOX (64253-020-23) / 3 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "64253-0020-23",
"ProductNDC": "64253-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sterile Water",
"NonProprietaryName": "Sterile Water For Injection",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20200127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211188",
"LabelerName": "Medefil, Inc.",
"SubstanceName": "WATER",
"StrengthNumber": "100",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200127",
"SamplePackage": "N",
"IndicationAndUsage": "This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.",
"Description": "This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. For intravenous injection, add sufficient solute to make an approximately isotonic solution. pH 5.0 to 7.0. Water for Injection, USP is chemically designated H2O. The plastic syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach our certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material."
},
{
"NDCCode": "64735-020-23",
"PackageDescription": "42650 L in 1 CYLINDER (64735-020-23)",
"NDC11Code": "64735-0020-23",
"ProductNDC": "64735-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19600101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205713",
"LabelerName": "Air Liquide Healthcare America Corporation",
"SubstanceName": "NITROGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "70380-020-01",
"PackageDescription": "23 mL in 1 CARTON (70380-020-01)",
"NDC11Code": "70380-0020-01",
"ProductNDC": "70380-020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ac Clear Sheet Mask",
"NonProprietaryName": "Glycerin",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160102",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "MIGUHARA",
"SubstanceName": "GLYCERIN",
"StrengthNumber": "1.84",
"StrengthUnit": "g/23mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Usage. 1. put skin or toner after washing up 2. open sheet mask and apply it tightly on the face. 3. remove it within 15 ~ 20 minutes after applying 4. pat gently until absorbed. 5. It is recommendable to use it 2 ~ 3times a week and store it in fridge before using."
},
{
"NDCCode": "70894-020-01",
"PackageDescription": "23 mL in 1 POUCH (70894-020-01)",
"NDC11Code": "70894-0020-01",
"ProductNDC": "70894-020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "The All Medicare V Pla Synergy Whitening Mask",
"NonProprietaryName": "Glycerin, Niacinamide",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "TAENAM MEDICOS CO., LTD",
"SubstanceName": "GLYCERIN; NIACINAMIDE",
"StrengthNumber": "1.85; .46",
"StrengthUnit": "g/23mL; g/23mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications and usage: ①After cleansing, clear up skin texture with toner to heighten the effects. ②Take the mask out of its package, unfold, and place the sheet on the face. ③Leave them for about 15~20 minutes and take them out slowly. ④Let the skin absorb the remaining essence by gently patting the skin."
},
{
"NDCCode": "71635-020-02",
"PackageDescription": "12 POUCH in 1 CARTON (71635-020-02) > 23 g in 1 POUCH (71635-020-01)",
"NDC11Code": "71635-0020-02",
"ProductNDC": "71635-020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mulbit Aqua Mask Pack",
"NonProprietaryName": "Niacinamide, Adenosine",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171001",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "First Cosmetic Co., Ltd",
"SubstanceName": "NIACINAMIDE; ADENOSINE",
"StrengthNumber": ".02; .002",
"StrengthUnit": "g/23g; g/23g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Uses: MULBIT AQUA MASK contains extract of oceanic organisms including jellyfish and marine collagen and gives nutrients and refreshing feeling to your skin. And the patented (10-1607503) ice plant callus extract makes the skin healthier."
},
{
"NDCCode": "75749-020-23",
"PackageDescription": "237 mL in 1 BOTTLE, PUMP (75749-020-23) ",
"NDC11Code": "75749-0020-23",
"ProductNDC": "75749-020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amoray Instant Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200707",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "NINGBO PRETTY TOURISM MANUFACTURE CO.,LTD.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200707",
"SamplePackage": "N",
"IndicationAndUsage": "hand sanitizer to help decrease bacteria on the skin. when water, soap & towel are not available. recommended for repeated use."
},
{
"NDCCode": "76772-020-23",
"PackageDescription": "236 mL in 1 BOTTLE (76772-020-23) ",
"NDC11Code": "76772-0020-23",
"ProductNDC": "76772-020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Luxury Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "to helps reduce bacteria on the skin. For use when soap and water are not available ."
},
{
"NDCCode": "85401-020-23",
"PackageDescription": "2 BLISTER PACK in 1 BOX (85401-020-23) / 2 SUPPOSITORY in 1 BLISTER PACK",
"NDC11Code": "85401-0020-23",
"ProductNDC": "85401-020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gyntima Probiotica",
"NonProprietaryName": "Lactic Acid, Folic Acid, Sage",
"DosageFormName": "SUPPOSITORY",
"RouteName": "VAGINAL",
"StartMarketingDate": "20250824",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Fytofontana LLC",
"SubstanceName": "LACTIC ACID, DL-; SAGE; FOLIC ACID",
"StrengthNumber": "2; 3; 4",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250824",
"SamplePackage": "N",
"IndicationAndUsage": "Women seeking preventive intimate care, particularly after. Antibiotic or disinfectant use. Swimming, sexual activity, or other microbiome disturbances. Occasional mild discomfort or irritation not requiring pharmaceutical treatment."
},
{
"NDCCode": "65219-028-05",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (65219-028-05) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "65219-0028-05",
"ProductNDC": "65219-028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ganirelix Acetate",
"NonProprietaryName": "Ganirelix Acetate",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215658",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "GANIRELIX ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "ug/.5mL",
"Pharm_Classes": "Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-05-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230324",
"SamplePackage": "N",
"IndicationAndUsage": "Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.",
"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."
},
{
"NDCCode": "65219-029-20",
"PackageDescription": "1 VIAL in 1 CARTON (65219-029-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "65219-0029-20",
"ProductNDC": "65219-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thiotepa",
"NonProprietaryName": "Thiotepa",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRACAVITARY; INTRAVENOUS; INTRAVESICAL",
"StartMarketingDate": "20220411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214222",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "THIOTEPA",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220411",
"SamplePackage": "N",
"IndicationAndUsage": "Thiotepa for injection is an alkylating drug indicated: For treatment of adenocarcinoma of the breast or ovary. (1.2) For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. (1.3) For treatment of superficial papillary carcinoma of the urinary bladder. (1.4).",
"Description": "Thiotepa is an alkylating agent. Thiotepa for injection, USP is supplied as a non-pyrogenic, sterile lyophilized white powder for intravenous, intracavitary, or intravesical use after reconstitution and dilution. Thiotepa for Injection, USP is available in a single-dose vial containing. 100 mg thiotepa. After reconstitution with 10 ml of water for injection, each ml contains 10 mg thiotepa. Thiotepa is a synthetic product with antitumor activity. The chemical name for thiotepa is Tris(1-aziridinyl)phosphine sulfide. Thiotepa has the following structural formula. Thiotepa, USP has the molecular formula C6H12N3PS, and a molecular weight of 189.23, and it appears as fine, white crystalline flakes, with a melting range of 52°C to 57°C. It is soluble in water and organic solvents. When reconstituted with sterile water for injection, the resulting solution has a pH of approximately 5.5 to 7.5. Thiotepa is unstable in acid medium."
},
{
"NDCCode": "65219-200-05",
"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) ",
"NDC11Code": "65219-0200-05",
"ProductNDC": "65219-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temsirolimus",
"NonProprietaryName": "Temsirolimus",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207383",
"LabelerName": "Fresenius Kabi USA, LLC",
"Status": "Active",
"LastUpdate": "2020-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201120",
"SamplePackage": "N",
"IndicationAndUsage": "Temsirolimus injection is indicated for the treatment of advanced renal cell carcinoma.",
"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."
},
{
"NDCCode": "65219-323-02",
"PackageDescription": "25 VIAL in 1 TRAY (65219-323-02) / 2 mL in 1 VIAL (65219-323-00) ",
"NDC11Code": "65219-0323-02",
"ProductNDC": "65219-323",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20091118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076972",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240122",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron Injection is a 5-HT3 receptor antagonist indicated for the prevention of: : 1 nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (1.1) , 2 postoperative nausea and/or vomiting. (1.2) .",
"Description": "The active ingredient of Ondansetron Injection, USP is ondansetron hydrochloride, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Its chemical name is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl) methyl]-4H-carbazol-4-one, monohydrochloride,dihydrate. It has the following structural formula:. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9 g/mol. Ondansetron is a white to off-white powder that is sparingly soluble in water. Each 1 mL of the preservative-free aqueous solution in the 2-mL single dose vial contains 2 mg of ondansetron as the hydrochloride; 9 mg of sodium chloride; and 0.5 mg of citric acid monohydrate and 0.25 mg of sodium citrate dihydrate as buffers in water for injection. Each 1 mL of the preserved aqueous solution in the 20-mL multiple dose vial contains 2 mg of ondansetron as the hydrochloride; 8.3 mg of sodium chloride; 0.5 mg of citric acid monohydrate and 0.25 mg of sodium citrate dihydrate as buffers; and 1.2 mg of methylparaben and 0.15 mg of propylparaben as preservatives in water for injection. Ondansetron Injection, USP is a clear, colorless, nonpyrogenic, sterile solution for intravenous or intramuscular use. The pH of the injection solution is 3.3 to 4.0."
},
{
"NDCCode": "65219-368-24",
"PackageDescription": "25 VIAL in 1 TRAY (65219-368-24) / 1 mL in 1 VIAL (65219-368-14) ",
"NDC11Code": "65219-0368-24",
"ProductNDC": "65219-368",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217598",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam Injection is indicated for the treatment of status epilepticus.",
"Description": "Lorazepam, a benzodiazepine with antianxiety, sedative, and anticonvulsant effects, is intended for the intramuscular or intravenous routes of administration. It has the chemical formula: 7-chloro-5(2- chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1, 4-benzodiazepin-2-one. The molecular weight is 321.16, and the C.A.S. No. is [846-49-1]. The structural formula is:. Lorazepam is a nearly white powder almost insoluble in water. Each mL of sterile injection contains 2 mg of lorazepam, 0.18 mL polyethylene glycol 400 in propylene glycol with 2% benzyl alcohol as preservative."
},
{
"NDCCode": "65219-387-05",
"PackageDescription": "20 BAG in 1 CASE (65219-387-05) > 500 mL in 1 BAG (65219-387-00) ",
"NDC11Code": "65219-0387-05",
"ProductNDC": "65219-387",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multiple Electrolytes Ph 5.5",
"NonProprietaryName": "Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride And Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215370",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "526; 502; 368; 37; 30",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"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]",
"Status": "Active",
"LastUpdate": "2022-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221021",
"SamplePackage": "N",
"IndicationAndUsage": "Multiple Electrolytes Injection, Type 1, USP, pH 5.5 is indicated as a source of water and electrolytes or as an alkalinizing agent.",
"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."
},
{
"NDCCode": "65219-387-10",
"PackageDescription": "10 BAG in 1 CASE (65219-387-10) > 1000 mL in 1 BAG (65219-387-02) ",
"NDC11Code": "65219-0387-10",
"ProductNDC": "65219-387",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multiple Electrolytes Ph 5.5",
"NonProprietaryName": "Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride And Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215370",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "526; 502; 368; 37; 30",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"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]",
"Status": "Active",
"LastUpdate": "2022-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221021",
"SamplePackage": "N",
"IndicationAndUsage": "Multiple Electrolytes Injection, Type 1, USP, pH 5.5 is indicated as a source of water and electrolytes or as an alkalinizing agent.",
"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."
},
{
"NDCCode": "65219-389-05",
"PackageDescription": "20 BAG in 1 CASE (65219-389-05) > 500 mL in 1 BAG (65219-389-00) ",
"NDC11Code": "65219-0389-05",
"ProductNDC": "65219-389",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multiple Electrolytes Ph 7.4",
"NonProprietaryName": "Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride And Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215371",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "526; 502; 368; 37; 30",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"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]",
"Status": "Active",
"LastUpdate": "2022-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221021",
"SamplePackage": "N",
"IndicationAndUsage": "Multiple Electrolytes Injection, Type 1, USP, pH 7.4 is indicated as a source of water and electrolytes or as an alkalinizing agent.",
"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."
},
{
"NDCCode": "65219-389-10",
"PackageDescription": "10 BAG in 1 CASE (65219-389-10) > 1000 mL in 1 BAG (65219-389-02) ",
"NDC11Code": "65219-0389-10",
"ProductNDC": "65219-389",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multiple Electrolytes Ph 7.4",
"NonProprietaryName": "Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride And Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215371",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "526; 502; 368; 37; 30",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"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]",
"Status": "Active",
"LastUpdate": "2022-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221021",
"SamplePackage": "N",
"IndicationAndUsage": "Multiple Electrolytes Injection, Type 1, USP, pH 7.4 is indicated as a source of water and electrolytes or as an alkalinizing agent.",
"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."
},
{
"NDCCode": "65219-668-01",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (65219-668-01) / 1 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "65219-0668-01",
"ProductNDC": "65219-668",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Conexxence",
"NonProprietaryName": "Denosumab",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761398",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "DENOSUMAB",
"StrengthNumber": "60",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "RANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "Conexxence is a RANK ligand (RANKL) inhibitor indicated for treatment: : 1 of postmenopausal women with osteoporosis at high risk for fracture (1.1) , 2 to increase bone mass in men with osteoporosis at high risk for fracture (1.2) , 3 of glucocorticoid-induced osteoporosis in men and women at high risk for fracture (1.3) , 4 to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer (1.4) , 5 to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer (1.5) .",
"Description": "Denosumab-bnht is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand). Denosumab-bnht has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Conexxence (denosumab-bnht) injection is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. Each 1 mL single-dose prefilled syringe of Conexxence contains 60 mg denosumab-bnht (60 mg/mL solution), 0.23 mg glacial acetic acid, 0.1 mg polysorbate 20, 1.07 mg sodium acetate, 47 mg sorbitol, and Water for Injection (USP). The pH is 5.2."
},
{
"NDCCode": "65219-818-10",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (65219-818-10) / 10 mL in 1 VIAL, GLASS",
"NDC11Code": "65219-0818-10",
"ProductNDC": "65219-818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nicardipine Hydrochloride",
"NonProprietaryName": "Nicardipine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217548",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "NICARDIPINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240911",
"SamplePackage": "N",
"IndicationAndUsage": "Nicardipine hydrochloride injection is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible. (1).",
"Description": "Nicardipine hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride injection, USP for intravenous administration contains 2.5 mg/mL of nicardipine hydrochloride. Nicardipine hydrochloride is a dihydropyridine derivative with IUPAC (International Union of Pure and Applied Chemistry) chemical name (±)-2-(benzyl-methyl amino) ethyl methyl 1,4-dihydro-2, 6-dimethyl-4- (m-nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride and has the following structure. Nicardipine hydrochloride is a pale yellow to yellow, odorless, powder or crystalline powder that has a melting point range of 179- 188oC (Melt with decomposition). It is soluble in methanol and glacial acetic acid, sparingly soluble in ethanol and chloroform, practically insoluble in ethyl ether and water. It has a molecular weight of 515.99. Nicardipine hydrochloride injection, USP is available as a sterile, non-pyrogenic, clear, yellow solution in 10 mL vials for intravenous infusion after dilution. Each mL contains 2.5 mg nicardipine hydrochloride, 0.305 mg benzoic acid, USP and 7.5 mg sodium chloride, USP, in Water for Injection, USP. Sodium hydroxide, NF, (q.s.) may have been added to adjust pH to 3.2 to 4.2."
},
{
"NDCCode": "65219-818-13",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (65219-818-13) / 10 mL in 1 VIAL, GLASS (65219-818-03) ",
"NDC11Code": "65219-0818-13",
"ProductNDC": "65219-818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nicardipine Hydrochloride",
"NonProprietaryName": "Nicardipine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217548",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "NICARDIPINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251117",
"SamplePackage": "N",
"IndicationAndUsage": "Nicardipine hydrochloride injection is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible. (1).",
"Description": "Nicardipine hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride injection, USP for intravenous administration contains 2.5 mg/mL of nicardipine hydrochloride. Nicardipine hydrochloride is a dihydropyridine derivative with IUPAC (International Union of Pure and Applied Chemistry) chemical name (±)-2-(benzyl-methyl amino) ethyl methyl 1,4-dihydro-2, 6-dimethyl-4- (m-nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride and has the following structure. Nicardipine hydrochloride is a pale yellow to yellow, odorless, powder or crystalline powder that has a melting point range of 179- 188oC (Melt with decomposition). It is soluble in methanol and glacial acetic acid, sparingly soluble in ethanol and chloroform, practically insoluble in ethyl ether and water. It has a molecular weight of 515.99. Nicardipine hydrochloride injection, USP is available as a sterile, non-pyrogenic, clear, yellow solution in 10 mL vials for intravenous infusion after dilution. Each mL contains 2.5 mg nicardipine hydrochloride, 0.305 mg benzoic acid, USP and 7.5 mg sodium chloride, USP, in Water for Injection, USP. Sodium hydroxide, NF, (q.s.) may have been added to adjust pH to 3.2 to 4.2."
},
{
"NDCCode": "65219-822-05",
"PackageDescription": "1 VIAL in 1 CARTON (65219-822-05) / .5 mL in 1 VIAL",
"NDC11Code": "65219-0822-05",
"ProductNDC": "65219-822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Otulfi",
"NonProprietaryName": "Ustekinumab-aauz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250929",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761379",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "45",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250929",
"SamplePackage": "N",
"IndicationAndUsage": "OTULFI is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: : 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1) , 2 active psoriatic arthritis (PsA). (1.2) , 3 moderately to severely active Crohn's disease (CD). (1.3) , 4 moderately to severely active ulcerative colitis. (1.4) .",
"Description": "Ustekinumab-aauz, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aauz is produced in a Chinese hamster ovary (CHO) cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aauz is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. OTULFI (ustekinumab-aauz) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to slightly brown-yellow solution with pH of 5.7- 6.3."
},
{
"NDCCode": "65219-824-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (65219-824-01) / .5 mL in 1 SYRINGE",
"NDC11Code": "65219-0824-01",
"ProductNDC": "65219-824",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Otulfi",
"NonProprietaryName": "Ustekinumab-aauz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20240222",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761379",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "45",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240222",
"SamplePackage": "N",
"IndicationAndUsage": "OTULFI is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: : 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1) , 2 active psoriatic arthritis (PsA). (1.2) , 3 moderately to severely active Crohn's disease (CD). (1.3) , 4 moderately to severely active ulcerative colitis. (1.4) .",
"Description": "Ustekinumab-aauz, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aauz is produced in a Chinese hamster ovary (CHO) cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aauz is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. OTULFI (ustekinumab-aauz) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to slightly brown-yellow solution with pH of 5.7- 6.3."
},
{
"NDCCode": "65219-826-26",
"PackageDescription": "1 SYRINGE in 1 CARTON (65219-826-26) / 1 mL in 1 SYRINGE",
"NDC11Code": "65219-0826-26",
"ProductNDC": "65219-826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Otulfi",
"NonProprietaryName": "Ustekinumab-aauz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20240222",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761379",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "90",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240222",
"SamplePackage": "N",
"IndicationAndUsage": "OTULFI is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: : 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1) , 2 active psoriatic arthritis (PsA). (1.2) , 3 moderately to severely active Crohn's disease (CD). (1.3) , 4 moderately to severely active ulcerative colitis. (1.4) .",
"Description": "Ustekinumab-aauz, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aauz is produced in a Chinese hamster ovary (CHO) cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aauz is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. OTULFI (ustekinumab-aauz) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to slightly brown-yellow solution with pH of 5.7- 6.3."
},
{
"NDCCode": "65219-828-05",
"PackageDescription": "1 VIAL in 1 CARTON (65219-828-05) / 26 mL in 1 VIAL",
"NDC11Code": "65219-0828-05",
"ProductNDC": "65219-828",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Otulfi",
"NonProprietaryName": "Ustekinumab-aauz",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240222",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761379",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "130",
"StrengthUnit": "mg/26mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240222",
"SamplePackage": "N",
"IndicationAndUsage": "OTULFI is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: : 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1) , 2 active psoriatic arthritis (PsA). (1.2) , 3 moderately to severely active Crohn's disease (CD). (1.3) , 4 moderately to severely active ulcerative colitis. (1.4) .",
"Description": "Ustekinumab-aauz, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aauz is produced in a Chinese hamster ovary (CHO) cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aauz is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. OTULFI (ustekinumab-aauz) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to slightly brown-yellow solution with pH of 5.7- 6.3."
},
{
"NDCCode": "65219-862-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (65219-862-01) / .5 mL in 1 SYRINGE",
"NDC11Code": "65219-0862-01",
"ProductNDC": "65219-862",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ustekinumab-aauz",
"NonProprietaryName": "Ustekinumab-aauz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761379",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "45",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251115",
"SamplePackage": "N",
"IndicationAndUsage": "Ustekinumab-aauz is a human interleukin-12 and -23 antagonist indicated for the treatment of:. Adult patients with: : 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1) , 2 active psoriatic arthritis (PsA). (1.2) , 3 moderately to severely active Crohn's disease (CD). (1.3) , 4 moderately to severely active ulcerative colitis. (1.4) .",
"Description": "Ustekinumab-aauz, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aauz is produced in a Chinese hamster ovary (CHO) cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aauz is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. Ustekinumab-aauz injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to slightly brown-yellow solution with pH of 5.7- 6.3."
},
{
"NDCCode": "65219-866-26",
"PackageDescription": "1 SYRINGE in 1 CARTON (65219-866-26) / 1 mL in 1 SYRINGE",
"NDC11Code": "65219-0866-26",
"ProductNDC": "65219-866",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ustekinumab-aauz",
"NonProprietaryName": "Ustekinumab-aauz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761379",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "90",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251115",
"SamplePackage": "N",
"IndicationAndUsage": "Ustekinumab-aauz is a human interleukin-12 and -23 antagonist indicated for the treatment of:. Adult patients with: : 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1) , 2 active psoriatic arthritis (PsA). (1.2) , 3 moderately to severely active Crohn's disease (CD). (1.3) , 4 moderately to severely active ulcerative colitis. (1.4) .",
"Description": "Ustekinumab-aauz, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aauz is produced in a Chinese hamster ovary (CHO) cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aauz is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. Ustekinumab-aauz injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to slightly brown-yellow solution with pH of 5.7- 6.3."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>65219-020-23</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (65219-020-23) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-020-03) </PackageDescription>
<NDC11Code>65219-0020-23</NDC11Code>
<ProductNDC>65219-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin</ProprietaryName>
<NonProprietaryName>Ampicillin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20191031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062797</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>AMPICILLIN SODIUM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by S. pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.</IndicationAndUsage>
<Description>Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl) amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10.</Description>
</NDC>
<NDC>
<NDCCode>65219-186-23</NDCCode>
<PackageDescription>10 VIAL in 1 TRAY (65219-186-23) / 5 mL in 1 VIAL (65219-186-13) </PackageDescription>
<NDC11Code>65219-0186-23</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>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</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 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.</Description>
</NDC>
<NDC>
<NDCCode>42411-020-23</NDCCode>
<PackageDescription>42650 L in 1 CYLINDER (42411-020-23)</PackageDescription>
<NDC11Code>42411-0020-23</NDC11Code>
<ProductNDC>42411-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen</ProprietaryName>
<NonProprietaryName>Nitrogen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19600101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205713</ApplicationNumber>
<LabelerName>Air Liquide America Specialty Gases LLC</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>59779-020-23</NDCCode>
<PackageDescription>113 g in 1 BOTTLE, PLASTIC (59779-020-23)</PackageDescription>
<NDC11Code>59779-0020-23</NDC11Code>
<ProductNDC>59779-020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Pharmacy Sunscreen Spf 45</ProprietaryName>
<NonProprietaryName>Octinoxate, Octocrlyene, Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121217</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE; ZINC OXIDE</SubstanceName>
<StrengthNumber>7.5; 8; 6.8</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent sunburn. higher SPF gives more sunburn protection. retains SPF after 80 minutes of activity in water.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64253-020-23</NDCCode>
<PackageDescription>60 SYRINGE, PLASTIC in 1 BOX (64253-020-23) / 3 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>64253-0020-23</NDC11Code>
<ProductNDC>64253-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sterile Water</ProprietaryName>
<NonProprietaryName>Sterile Water For Injection</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211188</ApplicationNumber>
<LabelerName>Medefil, Inc.</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.</IndicationAndUsage>
<Description>This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. For intravenous injection, add sufficient solute to make an approximately isotonic solution. pH 5.0 to 7.0. Water for Injection, USP is chemically designated H2O. The plastic syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach our certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.</Description>
</NDC>
<NDC>
<NDCCode>64735-020-23</NDCCode>
<PackageDescription>42650 L in 1 CYLINDER (64735-020-23)</PackageDescription>
<NDC11Code>64735-0020-23</NDC11Code>
<ProductNDC>64735-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen</ProprietaryName>
<NonProprietaryName>Nitrogen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19600101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205713</ApplicationNumber>
<LabelerName>Air Liquide Healthcare America Corporation</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>70380-020-01</NDCCode>
<PackageDescription>23 mL in 1 CARTON (70380-020-01)</PackageDescription>
<NDC11Code>70380-0020-01</NDC11Code>
<ProductNDC>70380-020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ac Clear Sheet Mask</ProprietaryName>
<NonProprietaryName>Glycerin</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160102</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>MIGUHARA</LabelerName>
<SubstanceName>GLYCERIN</SubstanceName>
<StrengthNumber>1.84</StrengthNumber>
<StrengthUnit>g/23mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Usage. 1. put skin or toner after washing up 2. open sheet mask and apply it tightly on the face. 3. remove it within 15 ~ 20 minutes after applying 4. pat gently until absorbed. 5. It is recommendable to use it 2 ~ 3times a week and store it in fridge before using.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70894-020-01</NDCCode>
<PackageDescription>23 mL in 1 POUCH (70894-020-01)</PackageDescription>
<NDC11Code>70894-0020-01</NDC11Code>
<ProductNDC>70894-020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>The All Medicare V Pla Synergy Whitening Mask</ProprietaryName>
<NonProprietaryName>Glycerin, Niacinamide</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>TAENAM MEDICOS CO., LTD</LabelerName>
<SubstanceName>GLYCERIN; NIACINAMIDE</SubstanceName>
<StrengthNumber>1.85; .46</StrengthNumber>
<StrengthUnit>g/23mL; g/23mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications and usage: ①After cleansing, clear up skin texture with toner to heighten the effects. ②Take the mask out of its package, unfold, and place the sheet on the face. ③Leave them for about 15~20 minutes and take them out slowly. ④Let the skin absorb the remaining essence by gently patting the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71635-020-02</NDCCode>
<PackageDescription>12 POUCH in 1 CARTON (71635-020-02) > 23 g in 1 POUCH (71635-020-01)</PackageDescription>
<NDC11Code>71635-0020-02</NDC11Code>
<ProductNDC>71635-020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mulbit Aqua Mask Pack</ProprietaryName>
<NonProprietaryName>Niacinamide, Adenosine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>First Cosmetic Co., Ltd</LabelerName>
<SubstanceName>NIACINAMIDE; ADENOSINE</SubstanceName>
<StrengthNumber>.02; .002</StrengthNumber>
<StrengthUnit>g/23g; g/23g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: MULBIT AQUA MASK contains extract of oceanic organisms including jellyfish and marine collagen and gives nutrients and refreshing feeling to your skin. And the patented (10-1607503) ice plant callus extract makes the skin healthier.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75749-020-23</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PUMP (75749-020-23) </PackageDescription>
<NDC11Code>75749-0020-23</NDC11Code>
<ProductNDC>75749-020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Amoray Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200707</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>NINGBO PRETTY TOURISM MANUFACTURE CO.,LTD.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>hand sanitizer to help decrease bacteria on the skin. when water, soap & towel are not available. recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76772-020-23</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE (76772-020-23) </PackageDescription>
<NDC11Code>76772-0020-23</NDC11Code>
<ProductNDC>76772-020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Luxury Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to helps reduce bacteria on the skin. For use when soap and water are not available .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85401-020-23</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 BOX (85401-020-23) / 2 SUPPOSITORY in 1 BLISTER PACK</PackageDescription>
<NDC11Code>85401-0020-23</NDC11Code>
<ProductNDC>85401-020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gyntima Probiotica</ProprietaryName>
<NonProprietaryName>Lactic Acid, Folic Acid, Sage</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20250824</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Fytofontana LLC</LabelerName>
<SubstanceName>LACTIC ACID, DL-; SAGE; FOLIC ACID</SubstanceName>
<StrengthNumber>2; 3; 4</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Women seeking preventive intimate care, particularly after. Antibiotic or disinfectant use. Swimming, sexual activity, or other microbiome disturbances. Occasional mild discomfort or irritation not requiring pharmaceutical treatment.</IndicationAndUsage>
</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>20261231</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>65219-029-20</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (65219-029-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>65219-0029-20</NDC11Code>
<ProductNDC>65219-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thiotepa</ProprietaryName>
<NonProprietaryName>Thiotepa</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRACAVITARY; INTRAVENOUS; INTRAVESICAL</RouteName>
<StartMarketingDate>20220411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214222</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>THIOTEPA</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Thiotepa for injection is an alkylating drug indicated: For treatment of adenocarcinoma of the breast or ovary. (1.2) For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. (1.3) For treatment of superficial papillary carcinoma of the urinary bladder. (1.4).</IndicationAndUsage>
<Description>Thiotepa is an alkylating agent. Thiotepa for injection, USP is supplied as a non-pyrogenic, sterile lyophilized white powder for intravenous, intracavitary, or intravesical use after reconstitution and dilution. Thiotepa for Injection, USP is available in a single-dose vial containing. 100 mg thiotepa. After reconstitution with 10 ml of water for injection, each ml contains 10 mg thiotepa. Thiotepa is a synthetic product with antitumor activity. The chemical name for thiotepa is Tris(1-aziridinyl)phosphine sulfide. Thiotepa has the following structural formula. Thiotepa, USP has the molecular formula C6H12N3PS, and a molecular weight of 189.23, and it appears as fine, white crystalline flakes, with a melting range of 52°C to 57°C. It is soluble in water and organic solvents. When reconstituted with sterile water for injection, the resulting solution has a pH of approximately 5.5 to 7.5. Thiotepa is unstable in acid medium.</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>20261231</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>65219-323-02</NDCCode>
<PackageDescription>25 VIAL in 1 TRAY (65219-323-02) / 2 mL in 1 VIAL (65219-323-00) </PackageDescription>
<NDC11Code>65219-0323-02</NDC11Code>
<ProductNDC>65219-323</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20091118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076972</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron Injection is a 5-HT3 receptor antagonist indicated for the prevention of: : 1 nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (1.1) , 2 postoperative nausea and/or vomiting. (1.2) .</IndicationAndUsage>
<Description>The active ingredient of Ondansetron Injection, USP is ondansetron hydrochloride, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Its chemical name is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl) methyl]-4H-carbazol-4-one, monohydrochloride,dihydrate. It has the following structural formula:. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9 g/mol. Ondansetron is a white to off-white powder that is sparingly soluble in water. Each 1 mL of the preservative-free aqueous solution in the 2-mL single dose vial contains 2 mg of ondansetron as the hydrochloride; 9 mg of sodium chloride; and 0.5 mg of citric acid monohydrate and 0.25 mg of sodium citrate dihydrate as buffers in water for injection. Each 1 mL of the preserved aqueous solution in the 20-mL multiple dose vial contains 2 mg of ondansetron as the hydrochloride; 8.3 mg of sodium chloride; 0.5 mg of citric acid monohydrate and 0.25 mg of sodium citrate dihydrate as buffers; and 1.2 mg of methylparaben and 0.15 mg of propylparaben as preservatives in water for injection. Ondansetron Injection, USP is a clear, colorless, nonpyrogenic, sterile solution for intravenous or intramuscular use. The pH of the injection solution is 3.3 to 4.0.</Description>
</NDC>
<NDC>
<NDCCode>65219-368-24</NDCCode>
<PackageDescription>25 VIAL in 1 TRAY (65219-368-24) / 1 mL in 1 VIAL (65219-368-14) </PackageDescription>
<NDC11Code>65219-0368-24</NDC11Code>
<ProductNDC>65219-368</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217598</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam Injection is indicated for the treatment of status epilepticus.</IndicationAndUsage>
<Description>Lorazepam, a benzodiazepine with antianxiety, sedative, and anticonvulsant effects, is intended for the intramuscular or intravenous routes of administration. It has the chemical formula: 7-chloro-5(2- chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1, 4-benzodiazepin-2-one. The molecular weight is 321.16, and the C.A.S. No. is [846-49-1]. The structural formula is:. Lorazepam is a nearly white powder almost insoluble in water. Each mL of sterile injection contains 2 mg of lorazepam, 0.18 mL polyethylene glycol 400 in propylene glycol with 2% benzyl alcohol as preservative.</Description>
</NDC>
<NDC>
<NDCCode>65219-387-05</NDCCode>
<PackageDescription>20 BAG in 1 CASE (65219-387-05) > 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>20261231</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>65219-387-10</NDCCode>
<PackageDescription>10 BAG in 1 CASE (65219-387-10) > 1000 mL in 1 BAG (65219-387-02) </PackageDescription>
<NDC11Code>65219-0387-10</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>20261231</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) > 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>20261231</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>65219-389-10</NDCCode>
<PackageDescription>10 BAG in 1 CASE (65219-389-10) > 1000 mL in 1 BAG (65219-389-02) </PackageDescription>
<NDC11Code>65219-0389-10</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>20261231</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>65219-668-01</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (65219-668-01) / 1 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>65219-0668-01</NDC11Code>
<ProductNDC>65219-668</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Conexxence</ProprietaryName>
<NonProprietaryName>Denosumab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250630</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761398</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>DENOSUMAB</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>RANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Conexxence is a RANK ligand (RANKL) inhibitor indicated for treatment: : 1 of postmenopausal women with osteoporosis at high risk for fracture (1.1) , 2 to increase bone mass in men with osteoporosis at high risk for fracture (1.2) , 3 of glucocorticoid-induced osteoporosis in men and women at high risk for fracture (1.3) , 4 to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer (1.4) , 5 to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer (1.5) .</IndicationAndUsage>
<Description>Denosumab-bnht is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand). Denosumab-bnht has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Conexxence (denosumab-bnht) injection is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. Each 1 mL single-dose prefilled syringe of Conexxence contains 60 mg denosumab-bnht (60 mg/mL solution), 0.23 mg glacial acetic acid, 0.1 mg polysorbate 20, 1.07 mg sodium acetate, 47 mg sorbitol, and Water for Injection (USP). The pH is 5.2.</Description>
</NDC>
<NDC>
<NDCCode>65219-818-10</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (65219-818-10) / 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>65219-0818-10</NDC11Code>
<ProductNDC>65219-818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nicardipine Hydrochloride</ProprietaryName>
<NonProprietaryName>Nicardipine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217548</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>NICARDIPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nicardipine hydrochloride injection is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible. (1).</IndicationAndUsage>
<Description>Nicardipine hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride injection, USP for intravenous administration contains 2.5 mg/mL of nicardipine hydrochloride. Nicardipine hydrochloride is a dihydropyridine derivative with IUPAC (International Union of Pure and Applied Chemistry) chemical name (±)-2-(benzyl-methyl amino) ethyl methyl 1,4-dihydro-2, 6-dimethyl-4- (m-nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride and has the following structure. Nicardipine hydrochloride is a pale yellow to yellow, odorless, powder or crystalline powder that has a melting point range of 179- 188oC (Melt with decomposition). It is soluble in methanol and glacial acetic acid, sparingly soluble in ethanol and chloroform, practically insoluble in ethyl ether and water. It has a molecular weight of 515.99. Nicardipine hydrochloride injection, USP is available as a sterile, non-pyrogenic, clear, yellow solution in 10 mL vials for intravenous infusion after dilution. Each mL contains 2.5 mg nicardipine hydrochloride, 0.305 mg benzoic acid, USP and 7.5 mg sodium chloride, USP, in Water for Injection, USP. Sodium hydroxide, NF, (q.s.) may have been added to adjust pH to 3.2 to 4.2.</Description>
</NDC>
<NDC>
<NDCCode>65219-818-13</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (65219-818-13) / 10 mL in 1 VIAL, GLASS (65219-818-03) </PackageDescription>
<NDC11Code>65219-0818-13</NDC11Code>
<ProductNDC>65219-818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nicardipine Hydrochloride</ProprietaryName>
<NonProprietaryName>Nicardipine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217548</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>NICARDIPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nicardipine hydrochloride injection is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible. (1).</IndicationAndUsage>
<Description>Nicardipine hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride injection, USP for intravenous administration contains 2.5 mg/mL of nicardipine hydrochloride. Nicardipine hydrochloride is a dihydropyridine derivative with IUPAC (International Union of Pure and Applied Chemistry) chemical name (±)-2-(benzyl-methyl amino) ethyl methyl 1,4-dihydro-2, 6-dimethyl-4- (m-nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride and has the following structure. Nicardipine hydrochloride is a pale yellow to yellow, odorless, powder or crystalline powder that has a melting point range of 179- 188oC (Melt with decomposition). It is soluble in methanol and glacial acetic acid, sparingly soluble in ethanol and chloroform, practically insoluble in ethyl ether and water. It has a molecular weight of 515.99. Nicardipine hydrochloride injection, USP is available as a sterile, non-pyrogenic, clear, yellow solution in 10 mL vials for intravenous infusion after dilution. Each mL contains 2.5 mg nicardipine hydrochloride, 0.305 mg benzoic acid, USP and 7.5 mg sodium chloride, USP, in Water for Injection, USP. Sodium hydroxide, NF, (q.s.) may have been added to adjust pH to 3.2 to 4.2.</Description>
</NDC>
<NDC>
<NDCCode>65219-822-05</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (65219-822-05) / .5 mL in 1 VIAL</PackageDescription>
<NDC11Code>65219-0822-05</NDC11Code>
<ProductNDC>65219-822</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Otulfi</ProprietaryName>
<NonProprietaryName>Ustekinumab-aauz</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250929</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761379</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OTULFI is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: : 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1) , 2 active psoriatic arthritis (PsA). (1.2) , 3 moderately to severely active Crohn's disease (CD). (1.3) , 4 moderately to severely active ulcerative colitis. (1.4) .</IndicationAndUsage>
<Description>Ustekinumab-aauz, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aauz is produced in a Chinese hamster ovary (CHO) cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aauz is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. OTULFI (ustekinumab-aauz) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to slightly brown-yellow solution with pH of 5.7- 6.3.</Description>
</NDC>
<NDC>
<NDCCode>65219-824-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (65219-824-01) / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>65219-0824-01</NDC11Code>
<ProductNDC>65219-824</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Otulfi</ProprietaryName>
<NonProprietaryName>Ustekinumab-aauz</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240222</StartMarketingDate>
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<Description>Ustekinumab-aauz, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aauz is produced in a Chinese hamster ovary (CHO) cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aauz is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. OTULFI (ustekinumab-aauz) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to slightly brown-yellow solution with pH of 5.7- 6.3.</Description>
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<Description>Ustekinumab-aauz, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aauz is produced in a Chinese hamster ovary (CHO) cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aauz is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. Ustekinumab-aauz injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to slightly brown-yellow solution with pH of 5.7- 6.3.</Description>
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<IndicationAndUsage>Ustekinumab-aauz is a human interleukin-12 and -23 antagonist indicated for the treatment of:. Adult patients with: : 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1) , 2 active psoriatic arthritis (PsA). (1.2) , 3 moderately to severely active Crohn's disease (CD). (1.3) , 4 moderately to severely active ulcerative colitis. (1.4) .</IndicationAndUsage>
<Description>Ustekinumab-aauz, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aauz is produced in a Chinese hamster ovary (CHO) cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aauz is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. Ustekinumab-aauz injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to slightly brown-yellow solution with pH of 5.7- 6.3.</Description>
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