RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "54162-250-80",
      "PackageDescription": "237 mL in 1 BOTTLE, PLASTIC (54162-250-80)",
      "NDC11Code": "54162-0250-80",
      "ProductNDC": "54162-250",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tera-gel",
      "NonProprietaryName": "Coal Tar",
      "DosageFormName": "SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150731",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part358H",
      "LabelerName": "Geritrex LLC",
      "SubstanceName": "COAL TAR",
      "StrengthNumber": "1.365",
      "StrengthUnit": "g/237mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "For best results, use at least twice a week or as directed by a physician. Wet hair and scalp thoroughly. Massage shampoo into scalp. Leave lather on hair and scalp for several minutes. Rinse and repeat."
    },
    {
      "NDCCode": "54162-250-04",
      "PackageDescription": "114 mL in 1 BOTTLE, PLASTIC (54162-250-04)",
      "NDC11Code": "54162-0250-04",
      "ProductNDC": "54162-250",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tera-gel",
      "NonProprietaryName": "Coal Tar",
      "DosageFormName": "SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150731",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part358H",
      "LabelerName": "Geritrex LLC",
      "SubstanceName": "COAL TAR",
      "StrengthNumber": ".57",
      "StrengthUnit": "g/114mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "For best results, use at least twice a week or as directed by a physician. Wet hair and scalp thoroughly. Massage shampoo into scalp. Leave lather on hair and scalp for several minutes. Rinse and repeat."
    },
    {
      "NDCCode": "0407-1414-80",
      "PackageDescription": "10 BOTTLE, GLASS in 1 BOX (0407-1414-80)  > 250 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "00407-1414-80",
      "ProductNDC": "0407-1414",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Omnipaque",
      "NonProprietaryName": "Iohexol",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19851226",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018956",
      "LabelerName": "GE Healthcare Inc.",
      "SubstanceName": "IOHEXOL",
      "StrengthNumber": "350",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-08-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "19851226",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "42361-250-01",
      "PackageDescription": "1 TUBE in 1 CARTON (42361-250-01)  > 80 g in 1 TUBE",
      "NDC11Code": "42361-0250-01",
      "ProductNDC": "42361-250",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Omar Sharif Everyday Sun Protection",
      "ProprietaryNameSuffix": "Broad Spectrum Spf 50",
      "NonProprietaryName": "Amiloxate, Bemotrizinol, Octinoxate, Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160919",
      "EndMarketingDate": "20171130",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Dong Sung Bio Pharm. Co., Ltd.",
      "SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE; BEMOTRIZINOL; AMILOXATE",
      "StrengthNumber": "25; 11; 75; 30; 20",
      "StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-03"
    },
    {
      "NDCCode": "43744-250-80",
      "PackageDescription": "20000 g in 1 DRUM (43744-250-80)",
      "NDC11Code": "43744-0250-80",
      "ProductNDC": "43744-250",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Dehydrocholic Acid",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20120707",
      "EndMarketingDate": "20130630",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "CBSCHEM LIMITED",
      "SubstanceName": "DEHYDROCHOLIC ACID",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20130630"
    },
    {
      "NDCCode": "49502-250-80",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (49502-250-80)  / 10 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "49502-0250-80",
      "ProductNDC": "49502-250",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Semglee",
      "NonProprietaryName": "Insulin Glargine-yfgn",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20211115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761201",
      "LabelerName": "Mylan Specialty L.P.",
      "SubstanceName": "INSULIN GLARGINE",
      "StrengthNumber": "100",
      "StrengthUnit": "[iU]/mL",
      "Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20211115",
      "SamplePackage": "N",
      "IndicationAndUsage": "SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.",
      "Description": "Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Vial. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), polysorbate-20 (20 mcg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. Prefilled pen. Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4."
    },
    {
      "NDCCode": "63545-250-01",
      "PackageDescription": "80 PELLET in 1 VIAL, GLASS (63545-250-01) ",
      "NDC11Code": "63545-0250-01",
      "ProductNDC": "63545-250",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Arundo Mauritanica",
      "NonProprietaryName": "Arundo Mauritanica",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210331",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, Inc.",
      "SubstanceName": "ARUNDO PLINIANA ROOT",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2021-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210331",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "67544-250-80",
      "PackageDescription": "180 TABLET in 1 BOTTLE, PLASTIC (67544-250-80)",
      "NDC11Code": "67544-0250-80",
      "ProductNDC": "67544-250",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lisinopril And Hydrochlorothiazide",
      "NonProprietaryName": "Lisinopril And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130122",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076113",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "LISINOPRIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "20; 12.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-05-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "69329-250-01",
      "PackageDescription": "1 KIT in 1 PACKAGE (69329-250-01)  *  1 TUBE in 1 KIT > 80 g in 1 TUBE (67877-251-80)  *  1 TUBE in 1 KIT > 118 mL in 1 TUBE (69329-253-02)",
      "NDC11Code": "69329-0250-01",
      "ProductNDC": "69329-250",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dermasilkrx Sdspak",
      "NonProprietaryName": "Triamcinolone Acetonide Cream, Dimethicone Cream",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20150720",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088042",
      "LabelerName": "Patchwerx Labs, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a). Its structural formula is. Each gram of triamcinolone acetonide cream contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate."
    },
    {
      "NDCCode": "80666-555-80",
      "PackageDescription": "250 mL in 1 BOTTLE (80666-555-80) ",
      "NDC11Code": "80666-0555-80",
      "ProductNDC": "80666-555",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Phoenix Hand Sanitizer Gel",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201001",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "THANH CONG PHARMACEUTICAL AND TRADING CO.,LTD",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20201001",
      "SamplePackage": "N",
      "IndicationAndUsage": " Help to clean hand quickly.  Resist bacteria without water, deodorizer."
    },
    {
      "NDCCode": "0004-0259-01",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0004-0259-01)  / 100 CAPSULE in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00004-0259-01",
      "ProductNDC": "0004-0259",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cellcept",
      "NonProprietaryName": "Mycophenolate Mofetil",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950503",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050722",
      "LabelerName": "Genentech, Inc.",
      "SubstanceName": "MYCOPHENOLATE MOFETIL",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19950503",
      "SamplePackage": "N",
      "IndicationAndUsage": "CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
      "Description": "CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide). Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)]."
    },
    {
      "NDCCode": "0004-0259-43",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0004-0259-43)  / 500 CAPSULE in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00004-0259-43",
      "ProductNDC": "0004-0259",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cellcept",
      "NonProprietaryName": "Mycophenolate Mofetil",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950503",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050722",
      "LabelerName": "Genentech, Inc.",
      "SubstanceName": "MYCOPHENOLATE MOFETIL",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19950503",
      "SamplePackage": "N",
      "IndicationAndUsage": "CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
      "Description": "CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide). Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)]."
    },
    {
      "NDCCode": "0004-0260-01",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0004-0260-01)  / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00004-0260-01",
      "ProductNDC": "0004-0260",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cellcept",
      "NonProprietaryName": "Mycophenolate Mofetil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19970619",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050723",
      "LabelerName": "Genentech, Inc.",
      "SubstanceName": "MYCOPHENOLATE MOFETIL",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19970619",
      "SamplePackage": "N",
      "IndicationAndUsage": "CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
      "Description": "CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide). Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)]."
    },
    {
      "NDCCode": "0004-0260-43",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0004-0260-43)  / 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00004-0260-43",
      "ProductNDC": "0004-0260",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cellcept",
      "NonProprietaryName": "Mycophenolate Mofetil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19970619",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050723",
      "LabelerName": "Genentech, Inc.",
      "SubstanceName": "MYCOPHENOLATE MOFETIL",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19970619",
      "SamplePackage": "N",
      "IndicationAndUsage": "CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
      "Description": "CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide). Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)]."
    },
    {
      "NDCCode": "0004-0261-29",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0004-0261-29)  / 225 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00004-0261-29",
      "ProductNDC": "0004-0261",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cellcept",
      "NonProprietaryName": "Mycophenolate Mofetil",
      "DosageFormName": "POWDER, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "19981001",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050759",
      "LabelerName": "Genentech, Inc.",
      "SubstanceName": "MYCOPHENOLATE MOFETIL",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19981001",
      "SamplePackage": "N",
      "IndicationAndUsage": "CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
      "Description": "CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide). Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)]."
    },
    {
      "NDCCode": "0004-0298-09",
      "PackageDescription": "4 VIAL in 1 CARTON (0004-0298-09)  / 20 mL in 1 VIAL",
      "NDC11Code": "00004-0298-09",
      "ProductNDC": "0004-0298",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cellcept",
      "NonProprietaryName": "Mycophenolate Mofetil Hydrochloride",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19980812",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050758",
      "LabelerName": "Genentech, Inc.",
      "SubstanceName": "MYCOPHENOLATE MOFETIL HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/20mL",
      "Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19980812",
      "SamplePackage": "N",
      "IndicationAndUsage": "CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
      "Description": "CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide). Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)]."
    },
    {
      "NDCCode": "0026-3821-25",
      "PackageDescription": "1 KIT in 1 BOX (0026-3821-25)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-99)  *  2.5 mL in 1 SYRINGE (0026-0426-02)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-01) ",
      "NDC11Code": "00026-3821-25",
      "ProductNDC": "0026-3821",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Kovaltry",
      "NonProprietaryName": "Antihemophilic Factor (recombinant)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160317",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125574",
      "LabelerName": "Bayer HealthCare LLC",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
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      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
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      "IndicationAndUsage": "KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:.",
      "Description": "KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates."
    },
    {
      "NDCCode": "0026-3821-99",
      "PackageDescription": "1 KIT in 1 BOX (0026-3821-99)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-99)  *  2.5 mL in 1 SYRINGE (0026-0426-02)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-01) ",
      "NDC11Code": "00026-3821-99",
      "ProductNDC": "0026-3821",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Kovaltry",
      "NonProprietaryName": "Antihemophilic Factor (recombinant)",
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      "StartMarketingDate": "20160317",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125574",
      "LabelerName": "Bayer HealthCare LLC",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
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      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160317",
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      "IndicationAndUsage": "KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:.",
      "Description": "KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates."
    },
    {
      "NDCCode": "0026-3822-25",
      "PackageDescription": "1 KIT in 1 BOX (0026-3822-25)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-99)  *  2.5 mL in 1 SYRINGE (0026-0426-02)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-01) ",
      "NDC11Code": "00026-3822-25",
      "ProductNDC": "0026-3822",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Kovaltry",
      "NonProprietaryName": "Antihemophilic Factor (recombinant)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160317",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125574",
      "LabelerName": "Bayer HealthCare LLC",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160317",
      "SamplePackage": "N",
      "IndicationAndUsage": "KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:.",
      "Description": "KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates."
    },
    {
      "NDCCode": "0026-3822-99",
      "PackageDescription": "1 KIT in 1 BOX (0026-3822-99)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-99)  *  2.5 mL in 1 SYRINGE (0026-0426-02)  *  2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-01) ",
      "NDC11Code": "00026-3822-99",
      "ProductNDC": "0026-3822",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Kovaltry",
      "NonProprietaryName": "Antihemophilic Factor (recombinant)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160317",
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      "Description": "KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates."
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    {
      "NDCCode": "0026-3824-99",
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      "Description": "KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates."
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      "NDCCode": "0026-3826-50",
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      "Description": "KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates."
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      "NDCCode": "0026-3826-99",
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      "Description": "KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates."
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      "NDCCode": "0026-3828-50",
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      "IndicationAndUsage": "KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:.",
      "Description": "KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates."
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      "NDCCode": "0026-3828-99",
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      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125574",
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      "IndicationAndUsage": "KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:.",
      "Description": "KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level. The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method. KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates."
    },
    {
      "NDCCode": "0049-0114-28",
      "PackageDescription": "15 mL in 1 VIAL, SINGLE-USE (0049-0114-28) ",
      "NDC11Code": "00049-0114-28",
      "ProductNDC": "0049-0114",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021632",
      "LabelerName": "Roerig",
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      "StrengthNumber": "50",
      "StrengthUnit": "mg/15mL",
      "Pharm_Classes": "Echinocandin Antifungal [EPC], Lipopeptides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-08-25",
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      "IndicationAndUsage": "ERAXIS is an echinocandin antifungal indicated for the treatment of the following infections: : 1 Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older) (1.1), 2 Esophageal candidiasis in adults (1.2).",
      "Description": "ERAXIS for Injection is a sterile, lyophilized product for intravenous (IV) infusion that contains anidulafungin. ERAXIS (anidulafungin) is a semi-synthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans. Anidulafungin is an echinocandin, a class of antifungal drugs that inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls. ERAXIS (anidulafungin) is 1-[(4R,5R)-4,5-dihydroxy-N2-[[4\"-(pentyloxy)[1,1':4',1\"-terphenyl]-4-yl]carbonyl]-L-ornithine]echinocandin B. Anidulafungin is a white to off-white powder that is practically insoluble in water and slightly soluble in ethanol. In addition to the active ingredient, anidulafungin, ERAXIS for Injection contains the following inactive ingredients. 50 mg/vial – fructose (50 mg), mannitol (250 mg), polysorbate 80 (125 mg), tartaric acid (5.6 mg), and sodium hydroxide and/or hydrochloric acid for pH adjustment. 100 mg/vial – fructose (100 mg), mannitol (500 mg), polysorbate 80 (250 mg), tartaric acid (11.2 mg), and sodium hydroxide and/or hydrochloric acid for pH adjustment. The empirical formula of anidulafungin is C58H73N7O17 and the formula weight is 1140.3. The structural formula is. Prior to administration, ERAXIS for Injection requires reconstitution with sterile Water for Injection and subsequent dilution with either 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline)."
    },
    {
      "NDCCode": "0049-0116-28",
      "PackageDescription": "30 mL in 1 VIAL, SINGLE-USE (0049-0116-28) ",
      "NDC11Code": "00049-0116-28",
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      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021632",
      "LabelerName": "Roerig",
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      "StrengthNumber": "100",
      "StrengthUnit": "mg/30mL",
      "Pharm_Classes": "Echinocandin Antifungal [EPC], Lipopeptides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-08-25",
      "PackageNdcExcludeFlag": "N",
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      "SamplePackage": "N",
      "IndicationAndUsage": "ERAXIS is an echinocandin antifungal indicated for the treatment of the following infections: : 1 Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older) (1.1), 2 Esophageal candidiasis in adults (1.2).",
      "Description": "ERAXIS for Injection is a sterile, lyophilized product for intravenous (IV) infusion that contains anidulafungin. ERAXIS (anidulafungin) is a semi-synthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans. Anidulafungin is an echinocandin, a class of antifungal drugs that inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls. ERAXIS (anidulafungin) is 1-[(4R,5R)-4,5-dihydroxy-N2-[[4\"-(pentyloxy)[1,1':4',1\"-terphenyl]-4-yl]carbonyl]-L-ornithine]echinocandin B. Anidulafungin is a white to off-white powder that is practically insoluble in water and slightly soluble in ethanol. In addition to the active ingredient, anidulafungin, ERAXIS for Injection contains the following inactive ingredients. 50 mg/vial – fructose (50 mg), mannitol (250 mg), polysorbate 80 (125 mg), tartaric acid (5.6 mg), and sodium hydroxide and/or hydrochloric acid for pH adjustment. 100 mg/vial – fructose (100 mg), mannitol (500 mg), polysorbate 80 (250 mg), tartaric acid (11.2 mg), and sodium hydroxide and/or hydrochloric acid for pH adjustment. The empirical formula of anidulafungin is C58H73N7O17 and the formula weight is 1140.3. The structural formula is. Prior to administration, ERAXIS for Injection requires reconstitution with sterile Water for Injection and subsequent dilution with either 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline)."
    },
    {
      "NDCCode": "0049-2242-01",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0049-2242-01)  / 30 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00049-2242-01",
      "ProductNDC": "0049-2242",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eraxis",
      "NonProprietaryName": "Anidulafungin",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20240220",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021632",
      "LabelerName": "Roerig",
      "SubstanceName": "ANIDULAFUNGIN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/30mL",
      "Pharm_Classes": "Echinocandin Antifungal [EPC], Lipopeptides [CS]",
      "Status": "Active",
      "LastUpdate": "2024-02-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240220",
      "SamplePackage": "N",
      "IndicationAndUsage": "ERAXIS is an echinocandin antifungal indicated for the treatment of the following infections: : 1 Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older) (1.1), 2 Esophageal candidiasis in adults (1.2).",
      "Description": "ERAXIS for Injection is a sterile, lyophilized product for intravenous (IV) infusion that contains anidulafungin. ERAXIS (anidulafungin) is a semi-synthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans. Anidulafungin is an echinocandin, a class of antifungal drugs that inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls. ERAXIS (anidulafungin) is 1-[(4R,5R)-4,5-dihydroxy-N2-[[4\"-(pentyloxy)[1,1':4',1\"-terphenyl]-4-yl]carbonyl]-L-ornithine]echinocandin B. Anidulafungin is a white to off-white powder that is practically insoluble in water and slightly soluble in ethanol. In addition to the active ingredient, anidulafungin, ERAXIS for Injection contains the following inactive ingredients. 100 mg/vial – fructose (100 mg), mannitol (500 mg), polysorbate 80 (250 mg), tartaric acid (11.2 mg), and sodium hydroxide and/or hydrochloric acid for pH adjustment. The empirical formula of anidulafungin is C58H73N7O17 and the formula weight is 1140.3. The structural formula is. Prior to administration, ERAXIS for Injection requires reconstitution with sterile Water for Injection and subsequent dilution with either 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline)."
    },
    {
      "NDCCode": "0054-0936-21",
      "PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0936-21) ",
      "NDC11Code": "00054-0936-21",
      "ProductNDC": "0054-0936",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tapentadol",
      "NonProprietaryName": "Tapentadol Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20251215",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA200533",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "TAPENTADOL HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tapentadol extended-release tablets are indicated for the management of: 1 Severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate., 2 Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.",
      "Description": "Tapentadol extended-release tablet is an opioid agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NOHCl. The n-octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets)."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"54162-250-80","ProprietaryName":"Tera-gel","NonProprietaryName":"Coal Tar"},{"NDCCode":"54162-250-04","ProprietaryName":"Tera-gel","NonProprietaryName":"Coal Tar"},{"NDCCode":"0407-1414-80","ProprietaryName":"Omnipaque","NonProprietaryName":"Iohexol"},{"NDCCode":"42361-250-01","ProprietaryName":"Omar Sharif Everyday Sun Protection","NonProprietaryName":"Amiloxate, Bemotrizinol, Octinoxate, Titanium Dioxide, Zinc Oxide"},{"NDCCode":"43744-250-80","NonProprietaryName":"Dehydrocholic Acid"},{"NDCCode":"49502-250-80","ProprietaryName":"Semglee","NonProprietaryName":"Insulin Glargine-yfgn"},{"NDCCode":"63545-250-01","ProprietaryName":"Arundo Mauritanica","NonProprietaryName":"Arundo Mauritanica"},{"NDCCode":"67544-250-80","ProprietaryName":"Lisinopril And Hydrochlorothiazide","NonProprietaryName":"Lisinopril And Hydrochlorothiazide"},{"NDCCode":"69329-250-01","ProprietaryName":"Dermasilkrx Sdspak","NonProprietaryName":"Triamcinolone Acetonide Cream, Dimethicone Cream"},{"NDCCode":"80666-555-80","ProprietaryName":"Phoenix Hand Sanitizer Gel","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"0004-0259-01","ProprietaryName":"Cellcept","NonProprietaryName":"Mycophenolate Mofetil"},{"NDCCode":"0004-0259-43","ProprietaryName":"Cellcept","NonProprietaryName":"Mycophenolate Mofetil"},{"NDCCode":"0004-0260-01","ProprietaryName":"Cellcept","NonProprietaryName":"Mycophenolate Mofetil"},{"NDCCode":"0004-0260-43","ProprietaryName":"Cellcept","NonProprietaryName":"Mycophenolate Mofetil"},{"NDCCode":"0004-0261-29","ProprietaryName":"Cellcept","NonProprietaryName":"Mycophenolate Mofetil"},{"NDCCode":"0004-0298-09","ProprietaryName":"Cellcept","NonProprietaryName":"Mycophenolate Mofetil Hydrochloride"},{"NDCCode":"0026-3821-25","ProprietaryName":"Kovaltry","NonProprietaryName":"Antihemophilic Factor (recombinant)"},{"NDCCode":"0026-3821-99","ProprietaryName":"Kovaltry","NonProprietaryName":"Antihemophilic Factor (recombinant)"},{"NDCCode":"0026-3822-25","ProprietaryName":"Kovaltry","NonProprietaryName":"Antihemophilic Factor (recombinant)"},{"NDCCode":"0026-3822-99","ProprietaryName":"Kovaltry","NonProprietaryName":"Antihemophilic Factor (recombinant)"},{"NDCCode":"0026-3824-25","ProprietaryName":"Kovaltry","NonProprietaryName":"Antihemophilic Factor (recombinant)"},{"NDCCode":"0026-3824-99","ProprietaryName":"Kovaltry","NonProprietaryName":"Antihemophilic Factor (recombinant)"},{"NDCCode":"0026-3826-50","ProprietaryName":"Kovaltry","NonProprietaryName":"Antihemophilic Factor (recombinant)"},{"NDCCode":"0026-3826-99","ProprietaryName":"Kovaltry","NonProprietaryName":"Antihemophilic Factor (recombinant)"},{"NDCCode":"0026-3828-50","ProprietaryName":"Kovaltry","NonProprietaryName":"Antihemophilic Factor (recombinant)"},{"NDCCode":"0026-3828-99","ProprietaryName":"Kovaltry","NonProprietaryName":"Antihemophilic Factor (recombinant)"},{"NDCCode":"0049-0114-28","ProprietaryName":"Eraxis","NonProprietaryName":"Anidulafungin"},{"NDCCode":"0049-0116-28","ProprietaryName":"Eraxis","NonProprietaryName":"Anidulafungin"},{"NDCCode":"0049-2242-01","ProprietaryName":"Eraxis","NonProprietaryName":"Anidulafungin"},{"NDCCode":"0054-0936-21","ProprietaryName":"Tapentadol","NonProprietaryName":"Tapentadol Hydrochloride"}]}
                    

<NDCList><NDC><NDCCode>54162-250-80</NDCCode><ProprietaryName>Tera-gel</ProprietaryName><NonProprietaryName>Coal Tar</NonProprietaryName></NDC><NDC><NDCCode>54162-250-04</NDCCode><ProprietaryName>Tera-gel</ProprietaryName><NonProprietaryName>Coal Tar</NonProprietaryName></NDC><NDC><NDCCode>0407-1414-80</NDCCode><ProprietaryName>Omnipaque</ProprietaryName><NonProprietaryName>Iohexol</NonProprietaryName></NDC><NDC><NDCCode>42361-250-01</NDCCode><ProprietaryName>Omar Sharif Everyday Sun Protection</ProprietaryName><NonProprietaryName>Amiloxate, Bemotrizinol, Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>43744-250-80</NDCCode><NonProprietaryName>Dehydrocholic Acid</NonProprietaryName></NDC><NDC><NDCCode>49502-250-80</NDCCode><ProprietaryName>Semglee</ProprietaryName><NonProprietaryName>Insulin Glargine-yfgn</NonProprietaryName></NDC><NDC><NDCCode>63545-250-01</NDCCode><ProprietaryName>Arundo Mauritanica</ProprietaryName><NonProprietaryName>Arundo Mauritanica</NonProprietaryName></NDC><NDC><NDCCode>67544-250-80</NDCCode><ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Lisinopril And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>69329-250-01</NDCCode><ProprietaryName>Dermasilkrx Sdspak</ProprietaryName><NonProprietaryName>Triamcinolone Acetonide Cream, Dimethicone Cream</NonProprietaryName></NDC><NDC><NDCCode>80666-555-80</NDCCode><ProprietaryName>Phoenix Hand Sanitizer Gel</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>0004-0259-01</NDCCode><ProprietaryName>Cellcept</ProprietaryName><NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName></NDC><NDC><NDCCode>0004-0259-43</NDCCode><ProprietaryName>Cellcept</ProprietaryName><NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName></NDC><NDC><NDCCode>0004-0260-01</NDCCode><ProprietaryName>Cellcept</ProprietaryName><NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName></NDC><NDC><NDCCode>0004-0260-43</NDCCode><ProprietaryName>Cellcept</ProprietaryName><NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName></NDC><NDC><NDCCode>0004-0261-29</NDCCode><ProprietaryName>Cellcept</ProprietaryName><NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName></NDC><NDC><NDCCode>0004-0298-09</NDCCode><ProprietaryName>Cellcept</ProprietaryName><NonProprietaryName>Mycophenolate Mofetil Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0026-3821-25</NDCCode><ProprietaryName>Kovaltry</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>0026-3821-99</NDCCode><ProprietaryName>Kovaltry</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>0026-3822-25</NDCCode><ProprietaryName>Kovaltry</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>0026-3822-99</NDCCode><ProprietaryName>Kovaltry</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>0026-3824-25</NDCCode><ProprietaryName>Kovaltry</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>0026-3824-99</NDCCode><ProprietaryName>Kovaltry</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>0026-3826-50</NDCCode><ProprietaryName>Kovaltry</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>0026-3826-99</NDCCode><ProprietaryName>Kovaltry</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>0026-3828-50</NDCCode><ProprietaryName>Kovaltry</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>0026-3828-99</NDCCode><ProprietaryName>Kovaltry</ProprietaryName><NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>0049-0114-28</NDCCode><ProprietaryName>Eraxis</ProprietaryName><NonProprietaryName>Anidulafungin</NonProprietaryName></NDC><NDC><NDCCode>0049-0116-28</NDCCode><ProprietaryName>Eraxis</ProprietaryName><NonProprietaryName>Anidulafungin</NonProprietaryName></NDC><NDC><NDCCode>0049-2242-01</NDCCode><ProprietaryName>Eraxis</ProprietaryName><NonProprietaryName>Anidulafungin</NonProprietaryName></NDC><NDC><NDCCode>0054-0936-21</NDCCode><ProprietaryName>Tapentadol</ProprietaryName><NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName></NDC></NDCList>