{
"NDC": [
{
"NDCCode": "50154-4000-8",
"PackageDescription": "236 mL in 1 BOTTLE (50154-4000-8)",
"NDC11Code": "50154-4000-08",
"ProductNDC": "50154-4000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Instant Hand Sanitizer With Shea Butter Beads",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100527",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Lantern Enterprises Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50154-4000-2",
"PackageDescription": "59 mL in 1 BOTTLE (50154-4000-2)",
"NDC11Code": "50154-4000-02",
"ProductNDC": "50154-4000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Instant Hand Sanitizer With Shea Butter Beads",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100527",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Lantern Enterprises Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50154-1060-8",
"PackageDescription": "9 mL in 1 PACKAGE (50154-1060-8)",
"NDC11Code": "50154-1060-08",
"ProductNDC": "50154-1060",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Instant Hand Sanitizer With Aloe And Vitamin E",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100506",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Lantern Enterprises Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50154-5000-8",
"PackageDescription": "236 mL in 1 BOTTLE (50154-5000-8)",
"NDC11Code": "50154-5000-08",
"ProductNDC": "50154-5000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Instant Hand Sanitizer Unscented With Moisturizer And Vitamin E",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100527",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Lantern Enterprises Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "44087-4000-8",
"PackageDescription": "8 BLISTER PACK in 1 CARTON (44087-4000-8) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "44087-4000-08",
"ProductNDC": "44087-4000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mavenclad",
"NonProprietaryName": "Cladribine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022561",
"LabelerName": "EMD Serono, Inc.",
"SubstanceName": "CLADRIBINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Purine Antimetabolite [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190401",
"SamplePackage": "N",
"IndicationAndUsage": "MAVENCLAD is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS [see Warnings and Precautions (5)]. Limitations of Use. MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile [see Warnings and Precautions (5)].",
"Description": "MAVENCLAD contains the nucleoside metabolic inhibitor cladribine, which is a white or almost white, non-hydroscopic, crystalline powder with the molecular formula C10H12ClN5O3 and molecular weight 285.69. It differs in structure from the naturally occurring nucleoside, deoxyadenosine, by the substitution of chlorine for hydrogen in the 2-position of the purine ring. The chemical name of cladribine is 2-chloro-2′-deoxy-adenosine. The structural formula is shown below. Cladribine is stable at slightly basic and at neutral pH. The main degradation pathway is hydrolysis and at acidic pH significant decomposition occurs with time. The ionization behavior of the molecule over the pH range 0 to 12 is characterized by a single pKa of approximately 1.21. MAVENCLAD is provided as 10 mg tablets for oral use. Each MAVENCLAD 10 mg tablet contains cladribine as an active ingredient and hydroxypropyl betadex, magnesium stearate, and sorbitol as inactive ingredients."
},
{
"NDCCode": "47682-931-51",
"PackageDescription": "4000 PACKET in 1 CASE (47682-931-51) > .8 mL in 1 PACKET",
"NDC11Code": "47682-0931-51",
"ProductNDC": "47682-931",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medi-first Plus Sterile Alcohol Pads",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111223",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Unifirst First Aid Corporation",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2017-08-23"
},
{
"NDCCode": "51552-0256-8",
"PackageDescription": "4000 mL in 1 CONTAINER (51552-0256-8) ",
"NDC11Code": "51552-0256-08",
"ProductNDC": "51552-0256",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ethyl Alcohol 200 Pr",
"DosageFormName": "LIQUID",
"StartMarketingDate": "19980401",
"EndMarketingDate": "20250704",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "1",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "01-APR-98",
"EndMarketingDatePackage": "04-JUL-25"
},
{
"NDCCode": "55154-0407-8",
"PackageDescription": "4000 CAPSULE in 1 BOTTLE, PLASTIC (55154-0407-8)",
"NDC11Code": "55154-0407-08",
"ProductNDC": "55154-0407",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flomax",
"NonProprietaryName": "Tamsulosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19970912",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020579",
"LabelerName": "Cardinal Health",
"SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "63586-0115-8",
"PackageDescription": "4000 g in 1 BOTTLE, GLASS (63586-0115-8) ",
"NDC11Code": "63586-0115-08",
"ProductNDC": "63586-0115",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Desmopressin Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20170925",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "PolyPeptide Laboratories (Sweden) AB",
"SubstanceName": "DESMOPRESSIN ACETATE",
"StrengthNumber": "4",
"StrengthUnit": "g/4g",
"Status": "Unfinished",
"LastUpdate": "2024-01-24",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "01-JUN-20"
},
{
"NDCCode": "75125-4000-8",
"PackageDescription": "1040.98824 L in 1 TANK (75125-4000-8) ",
"NDC11Code": "75125-4000-08",
"ProductNDC": "75125-4000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Essential Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200413",
"EndMarketingDate": "20230416",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Genesis Custom Chemical Blending",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200413",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "78354-0004-8",
"PackageDescription": "4000 mL in 1 BOTTLE (78354-0004-8) ",
"NDC11Code": "78354-0004-08",
"ProductNDC": "78354-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200522",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Pomok, S.A. de C.V.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200522",
"SamplePackage": "N",
"IndicationAndUsage": "Place enough product on hands to cover all surfaces. Rub hands together until dry."
},
{
"NDCCode": "78501-4000-8",
"PackageDescription": "500 mL in 1 BOTTLE (78501-4000-8) ",
"NDC11Code": "78501-4000-08",
"ProductNDC": "78501-4000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bv Bye Virus 99",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200629",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "COMERCIAL GOURA,S. DE R.L.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200629",
"SamplePackage": "N",
"IndicationAndUsage": "Use[s]. Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "83103-4000-1",
"PackageDescription": "1 TUBE in 1 PACKAGE (83103-4000-1) / 8 mg in 1 TUBE",
"NDC11Code": "83103-4000-01",
"ProductNDC": "83103-4000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ceile Shade Protect Broad Spectrum Spf 45 Sunscreen Amalfi",
"NonProprietaryName": "Ceile Shade Protect Broad Spectrum Spf 45 Sunscreen Amalfi",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260127",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "L�E COSMETICS INC",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "6.8; 5.85",
"StrengthUnit": "mg/100mg; mg/100mg",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260127",
"SamplePackage": "N",
"IndicationAndUsage": "● helps prevent sunburn ● if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "83295-4000-1",
"PackageDescription": "8 POUCH in 1 BOX (83295-4000-1) / 4 PATCH in 1 POUCH / 2.7 g in 1 PATCH",
"NDC11Code": "83295-4000-01",
"ProductNDC": "83295-4000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trubrexa",
"NonProprietaryName": "Lidocaine And Capsaicin",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20231003",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Strand Health Group",
"SubstanceName": "CAPSAICIN; LIDOCAINE",
"StrengthNumber": ".00025; .0475",
"StrengthUnit": "g/g; g/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231003",
"SamplePackage": "N",
"IndicationAndUsage": "Trubrexa TM Transdermal Patch is indicated in adults over the age of 12 years old for the treatment of acute and chronic pain in muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, and more.",
"Description": "Trubrexa TM Transdermal Patch is comprised of an adhesive material containing 4.75% lidocaine and 0.025% capsaicin. Each patch is 2 in x 2 in (5.08 cm x 5.08 cm) and consists of an adhesive side containing the active/inactive ingredients and an outer surface backing layer with breathable fabric. The adhesive side is covered with a removable, clear, unprinted, plastic film. The outer surface of the backing layer is imprinted with the Trubrexa TM Transdermal Patch logo. 4 patches are included in each pouch bag. The inactive ingredients include: Arnica, Magnesium, Polyacrylate, Vegan Glycerol, and Water. Trubrexa TM Transdermal Patch is Latex Free, Paraben Free, and Vegan."
},
{
"NDCCode": "85509-4000-3",
"PackageDescription": "8 POUCH in 1 BOX (85509-4000-3) / 4 PATCH in 1 POUCH / 2.7 g in 1 PATCH",
"NDC11Code": "85509-4000-03",
"ProductNDC": "85509-4000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trubrexa",
"NonProprietaryName": "Lidocaine And Capsaicin",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20231003",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PHOENIX RX LLC",
"SubstanceName": "CAPSAICIN; LIDOCAINE",
"StrengthNumber": ".00025; .0475",
"StrengthUnit": "g/g; g/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250720",
"SamplePackage": "N",
"IndicationAndUsage": "Trubrexa TMTransdermal Patch is indicated in adults over the age of 12 years old for the treatment of acute and chronic pain in muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, and more.",
"Description": "Trubrexa TMTransdermal Patch is comprised of an adhesive material containing 4.75% lidocaine and 0.025% capsaicin. Each patch is 2 in x 2 in (5.08 cm x 5.08 cm) and consists of an adhesive side containing the active/inactive ingredients and an outer surface backing layer with breathable fabric. The adhesive side is covered with a removable, clear, unprinted, plastic film. The outer surface of the backing layer is imprinted with the Trubrexa TMTransdermal Patch logo. 4 patches are included in each pouch bag. The inactive ingredients include: Arnica, Magnesium, Polyacrylate, Vegan Glycerol, and Water. Trubrexa TMTransdermal Patch is Latex Free, Paraben Free, and Vegan."
},
{
"NDCCode": "0026-3942-25",
"PackageDescription": "1 KIT in 1 BOX (0026-3942-25) * 2.5 mL in 1 VIAL (0026-4942-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4942-01) ",
"NDC11Code": "00026-3942-25",
"ProductNDC": "0026-3942",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Jivi",
"NonProprietaryName": "Antihemophilic Factor (recombinant) Pegylated-aucl",
"DosageFormName": "KIT",
"StartMarketingDate": "20180830",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125661",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180830",
"SamplePackage": "N",
"IndicationAndUsage": "JIVI, is indicated for use in previously treated adults and pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed 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 sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins."
},
{
"NDCCode": "0026-3942-99",
"PackageDescription": "1 KIT in 1 BOX (0026-3942-99) * 2.5 mL in 1 VIAL (0026-4942-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4942-01) ",
"NDC11Code": "00026-3942-99",
"ProductNDC": "0026-3942",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Jivi",
"NonProprietaryName": "Antihemophilic Factor (recombinant) Pegylated-aucl",
"DosageFormName": "KIT",
"StartMarketingDate": "20180830",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125661",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180830",
"SamplePackage": "N",
"IndicationAndUsage": "JIVI, is indicated for use in previously treated adults and pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed 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 sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins."
},
{
"NDCCode": "0026-3944-25",
"PackageDescription": "1 KIT in 1 BOX (0026-3944-25) * 2.5 mL in 1 VIAL (0026-4944-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4944-01) ",
"NDC11Code": "00026-3944-25",
"ProductNDC": "0026-3944",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Jivi",
"NonProprietaryName": "Antihemophilic Factor (recombinant) Pegylated-aucl",
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"IndicationAndUsage": "JIVI, is indicated for use in previously treated adults and pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed 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 sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins."
},
{
"NDCCode": "0065-0416-36",
"PackageDescription": "60 VIAL, SINGLE-DOSE in 1 CARTON (0065-0416-36) > .8 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00065-0416-36",
"ProductNDC": "0065-0416",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tears Naturale Free",
"NonProprietaryName": "Dextran 70, Hypromellose 2910",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19901101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "HYPROMELLOSE 2910 (4000 MPA.S); DEXTRAN 70",
"StrengthNumber": "3; 1",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20020301",
"SamplePackage": "N"
},
{
"NDCCode": "0065-5060-09",
"PackageDescription": "36 VIAL, SINGLE-DOSE in 1 CARTON (0065-5060-09) > .8 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00065-5060-09",
"ProductNDC": "0065-5060",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tears Naturale Free",
"NonProprietaryName": "Dextran 70, Hypromellose 2910",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19901101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "HYPROMELLOSE 2910 (4000 MPA.S); DEXTRAN 70",
"StrengthNumber": "3; 1",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0065-5060-10",
"PackageDescription": "60 VIAL, SINGLE-DOSE in 1 CARTON (0065-5060-10) > .8 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00065-5060-10",
"ProductNDC": "0065-5060",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tears Naturale Free",
"NonProprietaryName": "Dextran 70, Hypromellose 2910",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19901101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "HYPROMELLOSE 2910 (4000 MPA.S); DEXTRAN 70",
"StrengthNumber": "3; 1",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0069-1307-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0069-1307-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0069-1307-01) ",
"NDC11Code": "00069-1307-10",
"ProductNDC": "0069-1307",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Retacrit",
"NonProprietaryName": "Epoetin Alfa-epbx",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20180618",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125545",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "EPOETIN",
"StrengthNumber": "4000",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180618",
"SamplePackage": "N",
"IndicationAndUsage": "RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: 1 Treatment of anemia due tooChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).oZidovudine in patients with Human Immunodeficiency Virus (HIV) infection (1.2).oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3)., 2 Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).",
"Description": "Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin. RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in vials in multiple formulations. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL single-dose vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL multiple-dose vial of 20,000 Units of epoetin alfa-epbx contains benzyl alcohol (8.5 mg), L-methionine (0.45 mg), polysorbate 20 (0.04 mg), sodium phosphate dibasic anhydrous (0.09 mg), sodium phosphate monobasic monohydrate (2.67 mg), and sucrose (60 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6). Each 2 mL multiple-dose vial of 20,000 Units (10,000 Units/mL) of epoetin alfa-epbx contains benzyl alcohol (17 mg), L-methionine (0.9 mg), polysorbate 20 (0.08 mg), sodium phosphate dibasic anhydrous (0.18 mg), sodium phosphate monobasic monohydrate (5.34 mg), and sucrose (120 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6)."
},
{
"NDCCode": "0093-4000-62",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (0093-4000-62) / 1 KIT in 1 BLISTER PACK (0093-4000-28) * 24 TABLET in 1 BLISTER PACK (0093-3634-11) * 4 TABLET in 1 BLISTER PACK (0093-3622-22) ",
"NDC11Code": "00093-4000-62",
"ProductNDC": "0093-4000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vestura",
"NonProprietaryName": "Drospirenone And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20210302",
"EndMarketingDate": "20260531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078833",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Deprecated",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210302",
"EndMarketingDatePackage": "20260531",
"SamplePackage": "N",
"IndicationAndUsage": "Vestura is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3).",
"Description": "Vestura® (drospirenone and ethinyl estradiol) tablets, USP provides an oral contraceptive regimen consisting of 24 pink active uncoated tablets each containing 3 mg of drospirenone, USP and 0.02 mg of ethinyl estradiol, USP (stabilized using vitamin E and an enhanced processing technique) and 4 peach inert uncoated tablets. The inactive ingredients in the pink tablets are lactose monohydrate, corn starch, pregelatinized corn starch, magnesium stearate, and FD&C Red #40. The peach inert uncoated tablets contain lactose anhydrous, microcrystalline cellulose, FD&C Yellow #6, and magnesium stearate. Drospirenone, USP (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3’,4’,6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16]cyclopenta[a]phenanthrene-17,2’(5H)-furan]-3,5’(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol, USP (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>50154-4000-8</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE (50154-4000-8)</PackageDescription>
<NDC11Code>50154-4000-08</NDC11Code>
<ProductNDC>50154-4000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Instant Hand Sanitizer With Shea Butter Beads</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Lantern Enterprises Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50154-4000-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE (50154-4000-2)</PackageDescription>
<NDC11Code>50154-4000-02</NDC11Code>
<ProductNDC>50154-4000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Instant Hand Sanitizer With Shea Butter Beads</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Lantern Enterprises Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50154-1060-8</NDCCode>
<PackageDescription>9 mL in 1 PACKAGE (50154-1060-8)</PackageDescription>
<NDC11Code>50154-1060-08</NDC11Code>
<ProductNDC>50154-1060</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Instant Hand Sanitizer With Aloe And Vitamin E</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100506</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Lantern Enterprises Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50154-5000-8</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE (50154-5000-8)</PackageDescription>
<NDC11Code>50154-5000-08</NDC11Code>
<ProductNDC>50154-5000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Instant Hand Sanitizer Unscented With Moisturizer And Vitamin E</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Lantern Enterprises Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44087-4000-8</NDCCode>
<PackageDescription>8 BLISTER PACK in 1 CARTON (44087-4000-8) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>44087-4000-08</NDC11Code>
<ProductNDC>44087-4000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mavenclad</ProprietaryName>
<NonProprietaryName>Cladribine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022561</ApplicationNumber>
<LabelerName>EMD Serono, Inc.</LabelerName>
<SubstanceName>CLADRIBINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Purine Antimetabolite [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MAVENCLAD is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS [see Warnings and Precautions (5)]. Limitations of Use. MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile [see Warnings and Precautions (5)].</IndicationAndUsage>
<Description>MAVENCLAD contains the nucleoside metabolic inhibitor cladribine, which is a white or almost white, non-hydroscopic, crystalline powder with the molecular formula C10H12ClN5O3 and molecular weight 285.69. It differs in structure from the naturally occurring nucleoside, deoxyadenosine, by the substitution of chlorine for hydrogen in the 2-position of the purine ring. The chemical name of cladribine is 2-chloro-2′-deoxy-adenosine. The structural formula is shown below. Cladribine is stable at slightly basic and at neutral pH. The main degradation pathway is hydrolysis and at acidic pH significant decomposition occurs with time. The ionization behavior of the molecule over the pH range 0 to 12 is characterized by a single pKa of approximately 1.21. MAVENCLAD is provided as 10 mg tablets for oral use. Each MAVENCLAD 10 mg tablet contains cladribine as an active ingredient and hydroxypropyl betadex, magnesium stearate, and sorbitol as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>47682-931-51</NDCCode>
<PackageDescription>4000 PACKET in 1 CASE (47682-931-51) > .8 mL in 1 PACKET</PackageDescription>
<NDC11Code>47682-0931-51</NDC11Code>
<ProductNDC>47682-931</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medi-first Plus Sterile Alcohol Pads</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111223</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Unifirst First Aid Corporation</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-08-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>51552-0256-8</NDCCode>
<PackageDescription>4000 mL in 1 CONTAINER (51552-0256-8) </PackageDescription>
<NDC11Code>51552-0256-08</NDC11Code>
<ProductNDC>51552-0256</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ethyl Alcohol 200 Pr</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>19980401</StartMarketingDate>
<EndMarketingDate>20250704</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>01-APR-98</StartMarketingDatePackage>
<EndMarketingDatePackage>04-JUL-25</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>55154-0407-8</NDCCode>
<PackageDescription>4000 CAPSULE in 1 BOTTLE, PLASTIC (55154-0407-8)</PackageDescription>
<NDC11Code>55154-0407-08</NDC11Code>
<ProductNDC>55154-0407</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flomax</ProprietaryName>
<NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970912</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020579</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>63586-0115-8</NDCCode>
<PackageDescription>4000 g in 1 BOTTLE, GLASS (63586-0115-8) </PackageDescription>
<NDC11Code>63586-0115-08</NDC11Code>
<ProductNDC>63586-0115</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20170925</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>PolyPeptide Laboratories (Sweden) AB</LabelerName>
<SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/4g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-01-24</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JUN-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>75125-4000-8</NDCCode>
<PackageDescription>1040.98824 L in 1 TANK (75125-4000-8) </PackageDescription>
<NDC11Code>75125-4000-08</NDC11Code>
<ProductNDC>75125-4000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Essential Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200413</StartMarketingDate>
<EndMarketingDate>20230416</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Genesis Custom Chemical Blending</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200413</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>78354-0004-8</NDCCode>
<PackageDescription>4000 mL in 1 BOTTLE (78354-0004-8) </PackageDescription>
<NDC11Code>78354-0004-08</NDC11Code>
<ProductNDC>78354-0004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200522</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Pomok, S.A. de C.V.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Place enough product on hands to cover all surfaces. Rub hands together until dry.</IndicationAndUsage>
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<NDCCode>78501-4000-8</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (78501-4000-8) </PackageDescription>
<NDC11Code>78501-4000-08</NDC11Code>
<ProductNDC>78501-4000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bv Bye Virus 99</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>COMERCIAL GOURA,S. DE R.L.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use[s]. Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83103-4000-1</NDCCode>
<PackageDescription>1 TUBE in 1 PACKAGE (83103-4000-1) / 8 mg in 1 TUBE</PackageDescription>
<NDC11Code>83103-4000-01</NDC11Code>
<ProductNDC>83103-4000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ceile Shade Protect Broad Spectrum Spf 45 Sunscreen Amalfi</ProprietaryName>
<NonProprietaryName>Ceile Shade Protect Broad Spectrum Spf 45 Sunscreen Amalfi</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260127</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>L�E COSMETICS INC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
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<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>● helps prevent sunburn ● if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83295-4000-1</NDCCode>
<PackageDescription>8 POUCH in 1 BOX (83295-4000-1) / 4 PATCH in 1 POUCH / 2.7 g in 1 PATCH</PackageDescription>
<NDC11Code>83295-4000-01</NDC11Code>
<ProductNDC>83295-4000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trubrexa</ProprietaryName>
<NonProprietaryName>Lidocaine And Capsaicin</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20231003</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Strand Health Group</LabelerName>
<SubstanceName>CAPSAICIN; LIDOCAINE</SubstanceName>
<StrengthNumber>.00025; .0475</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trubrexa TM Transdermal Patch is indicated in adults over the age of 12 years old for the treatment of acute and chronic pain in muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, and more.</IndicationAndUsage>
<Description>Trubrexa TM Transdermal Patch is comprised of an adhesive material containing 4.75% lidocaine and 0.025% capsaicin. Each patch is 2 in x 2 in (5.08 cm x 5.08 cm) and consists of an adhesive side containing the active/inactive ingredients and an outer surface backing layer with breathable fabric. The adhesive side is covered with a removable, clear, unprinted, plastic film. The outer surface of the backing layer is imprinted with the Trubrexa TM Transdermal Patch logo. 4 patches are included in each pouch bag. The inactive ingredients include: Arnica, Magnesium, Polyacrylate, Vegan Glycerol, and Water. Trubrexa TM Transdermal Patch is Latex Free, Paraben Free, and Vegan.</Description>
</NDC>
<NDC>
<NDCCode>85509-4000-3</NDCCode>
<PackageDescription>8 POUCH in 1 BOX (85509-4000-3) / 4 PATCH in 1 POUCH / 2.7 g in 1 PATCH</PackageDescription>
<NDC11Code>85509-4000-03</NDC11Code>
<ProductNDC>85509-4000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trubrexa</ProprietaryName>
<NonProprietaryName>Lidocaine And Capsaicin</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
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<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PHOENIX RX LLC</LabelerName>
<SubstanceName>CAPSAICIN; LIDOCAINE</SubstanceName>
<StrengthNumber>.00025; .0475</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trubrexa TMTransdermal Patch is indicated in adults over the age of 12 years old for the treatment of acute and chronic pain in muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, and more.</IndicationAndUsage>
<Description>Trubrexa TMTransdermal Patch is comprised of an adhesive material containing 4.75% lidocaine and 0.025% capsaicin. Each patch is 2 in x 2 in (5.08 cm x 5.08 cm) and consists of an adhesive side containing the active/inactive ingredients and an outer surface backing layer with breathable fabric. The adhesive side is covered with a removable, clear, unprinted, plastic film. The outer surface of the backing layer is imprinted with the Trubrexa TMTransdermal Patch logo. 4 patches are included in each pouch bag. The inactive ingredients include: Arnica, Magnesium, Polyacrylate, Vegan Glycerol, and Water. Trubrexa TMTransdermal Patch is Latex Free, Paraben Free, and Vegan.</Description>
</NDC>
<NDC>
<NDCCode>0026-3942-25</NDCCode>
<PackageDescription>1 KIT in 1 BOX (0026-3942-25) * 2.5 mL in 1 VIAL (0026-4942-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4942-01) </PackageDescription>
<NDC11Code>00026-3942-25</NDC11Code>
<ProductNDC>0026-3942</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Jivi</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant) Pegylated-aucl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180830</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125661</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JIVI, is indicated for use in previously treated adults and pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed 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 sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins.</Description>
</NDC>
<NDC>
<NDCCode>0026-3942-99</NDCCode>
<PackageDescription>1 KIT in 1 BOX (0026-3942-99) * 2.5 mL in 1 VIAL (0026-4942-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4942-01) </PackageDescription>
<NDC11Code>00026-3942-99</NDC11Code>
<ProductNDC>0026-3942</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Jivi</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant) Pegylated-aucl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180830</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125661</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JIVI, is indicated for use in previously treated adults and pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed 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 sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins.</Description>
</NDC>
<NDC>
<NDCCode>0026-3944-25</NDCCode>
<PackageDescription>1 KIT in 1 BOX (0026-3944-25) * 2.5 mL in 1 VIAL (0026-4944-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4944-01) </PackageDescription>
<NDC11Code>00026-3944-25</NDC11Code>
<ProductNDC>0026-3944</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Jivi</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant) Pegylated-aucl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180830</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125661</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JIVI, is indicated for use in previously treated adults and pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed 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 sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins.</Description>
</NDC>
<NDC>
<NDCCode>0026-3944-99</NDCCode>
<PackageDescription>1 KIT in 1 BOX (0026-3944-99) * 2.5 mL in 1 VIAL (0026-4944-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4944-01) </PackageDescription>
<NDC11Code>00026-3944-99</NDC11Code>
<ProductNDC>0026-3944</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Jivi</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant) Pegylated-aucl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180830</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125661</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JIVI, is indicated for use in previously treated adults and pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed 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 sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins.</Description>
</NDC>
<NDC>
<NDCCode>0026-3946-25</NDCCode>
<PackageDescription>1 KIT in 1 BOX (0026-3946-25) * 2.5 mL in 1 VIAL (0026-4946-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4946-01) </PackageDescription>
<NDC11Code>00026-3946-25</NDC11Code>
<ProductNDC>0026-3946</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Jivi</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant) Pegylated-aucl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180830</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125661</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180830</StartMarketingDatePackage>
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<IndicationAndUsage>JIVI, is indicated for use in previously treated adults and pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
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<Description>JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed 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 sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins.</Description>
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<Description>JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed 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 sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins.</Description>
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<NDC>
<NDCCode>0069-1307-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0069-1307-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0069-1307-01) </PackageDescription>
<NDC11Code>00069-1307-10</NDC11Code>
<ProductNDC>0069-1307</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Retacrit</ProprietaryName>
<NonProprietaryName>Epoetin Alfa-epbx</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180618</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125545</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>EPOETIN</SubstanceName>
<StrengthNumber>4000</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: 1 Treatment of anemia due tooChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).oZidovudine in patients with Human Immunodeficiency Virus (HIV) infection (1.2).oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3)., 2 Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).</IndicationAndUsage>
<Description>Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin. RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in vials in multiple formulations. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL single-dose vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL multiple-dose vial of 20,000 Units of epoetin alfa-epbx contains benzyl alcohol (8.5 mg), L-methionine (0.45 mg), polysorbate 20 (0.04 mg), sodium phosphate dibasic anhydrous (0.09 mg), sodium phosphate monobasic monohydrate (2.67 mg), and sucrose (60 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6). Each 2 mL multiple-dose vial of 20,000 Units (10,000 Units/mL) of epoetin alfa-epbx contains benzyl alcohol (17 mg), L-methionine (0.9 mg), polysorbate 20 (0.08 mg), sodium phosphate dibasic anhydrous (0.18 mg), sodium phosphate monobasic monohydrate (5.34 mg), and sucrose (120 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6).</Description>
</NDC>
<NDC>
<NDCCode>0093-4000-62</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (0093-4000-62) / 1 KIT in 1 BLISTER PACK (0093-4000-28) * 24 TABLET in 1 BLISTER PACK (0093-3634-11) * 4 TABLET in 1 BLISTER PACK (0093-3622-22) </PackageDescription>
<NDC11Code>00093-4000-62</NDC11Code>
<ProductNDC>0093-4000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vestura</ProprietaryName>
<NonProprietaryName>Drospirenone And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210302</StartMarketingDate>
<EndMarketingDate>20260531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078833</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210302</StartMarketingDatePackage>
<EndMarketingDatePackage>20260531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vestura is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3).</IndicationAndUsage>
<Description>Vestura® (drospirenone and ethinyl estradiol) tablets, USP provides an oral contraceptive regimen consisting of 24 pink active uncoated tablets each containing 3 mg of drospirenone, USP and 0.02 mg of ethinyl estradiol, USP (stabilized using vitamin E and an enhanced processing technique) and 4 peach inert uncoated tablets. The inactive ingredients in the pink tablets are lactose monohydrate, corn starch, pregelatinized corn starch, magnesium stearate, and FD&C Red #40. The peach inert uncoated tablets contain lactose anhydrous, microcrystalline cellulose, FD&C Yellow #6, and magnesium stearate. Drospirenone, USP (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3’,4’,6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16]cyclopenta[a]phenanthrene-17,2’(5H)-furan]-3,5’(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol, USP (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows.</Description>
</NDC>
</NDCList>