{
"NDC": [
{
"NDCCode": "72603-410-25",
"PackageDescription": "25 VIAL in 1 CARTON (72603-410-25) / 2 mL in 1 VIAL (72603-410-01) ",
"NDC11Code": "72603-0410-25",
"ProductNDC": "72603-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20240501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217692",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-07-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240501",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine hydrochloride injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.",
"Description": "Lidocaine hydrochloride injection, USP is sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS AND USAGE section for specific uses. Lidocaine hydrochloride injection, USP solution contain lidocaine hydrochloride, USP which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine hydrochloride, USP (C14H22N2OHCl) has the following structural formula. Lidocaine hydrochloride injection, USP is a clear, colorless, sterile, nonpyrogenic, isotonic solution containing sodium chloride. The pH of this solution is adjusted to approximately 5.0 to 7.0 with sodium hydroxide and/or hydrochloric acid."
},
{
"NDCCode": "11410-410-47",
"PackageDescription": "25 mL in 1 BOTTLE, DISPENSING (11410-410-47)",
"NDC11Code": "11410-0410-47",
"ProductNDC": "11410-410",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jane Seymour Natural Advantage",
"ProprietaryNameSuffix": "Am Spf 15 All Day Moisture With Ahas",
"NonProprietaryName": "Octinoxate, Oxybenzone, And Octisalate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080508",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "OCTINOXATE; OXYBENZONE; OCTISALATE",
"StrengthNumber": ".075; .04; .035",
"StrengthUnit": "mL/mL; mg/mL; mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "12943-410-01",
"PackageDescription": "25 kg in 1 CONTAINER (12943-410-01)",
"NDC11Code": "12943-0410-01",
"ProductNDC": "12943-410",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110525",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "SCORA",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "21130-410-52",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (21130-410-52) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "21130-0410-52",
"ProductNDC": "21130-410",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gentle Laxative",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "BETTER LIVING BRANDS LLC.",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230601",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. : 1 for relief of occasional constipation and irregularity, 2 this product generally produces bowel movement in 6-12 hours."
},
{
"NDCCode": "43598-410-25",
"PackageDescription": "5 POUCH in 1 CARTON (43598-410-25) / 5 VIAL in 1 POUCH (43598-410-05) / 3 mL in 1 VIAL",
"NDC11Code": "43598-0410-25",
"ProductNDC": "43598-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levalbuterol Inhalation",
"NonProprietaryName": "Levalbuterol Inhalation 0.63mg/3ml",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078171",
"LabelerName": "Dr. Reddy�s Laboratories, Inc.",
"SubstanceName": "LEVALBUTEROL",
"StrengthNumber": ".63",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140916",
"SamplePackage": "N",
"IndicationAndUsage": "Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.",
"Description": "Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg (0.0103%) of Levalbuterol (as 0.36 mg of levalbuterol HCl) or 0.63 mg (0.021%) of levalbuterol (as 0.73 mg of levalbuterol HCl) or 1.25 mg (0.042%) of levalbuterol (as 1.44 mg of levalbuterol HCl), edetate disodium as a chelating agent, sodium chloride to adjust tonicity, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5)."
},
{
"NDCCode": "43744-410-25",
"PackageDescription": "25 g in 1 DRUM (43744-410-25)",
"NDC11Code": "43744-0410-25",
"ProductNDC": "43744-410",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Flucytosine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130110",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "FLUCYTOSINE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "53329-410-59",
"PackageDescription": "25 PACKET in 1 BOX (53329-410-59) / 1 APPLICATOR in 1 PACKET / 1.4 g in 1 APPLICATOR",
"NDC11Code": "53329-0410-59",
"ProductNDC": "53329-410",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mediplast",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "PLASTER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M030",
"LabelerName": "Medline Industries, LP",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "40",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080801",
"SamplePackage": "N",
"IndicationAndUsage": "for the removal of corns and calluses. Relieves pain by removing corns and calluses. for the removal of common warts. The common wart is easily recognized by the rough ‘cauliflower-like’ appearance of the surface. for the removal of plantar warts on the bottom of the foot. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern."
},
{
"NDCCode": "55570-410-12",
"PackageDescription": "25 kg in 1 BOX (55570-410-12) ",
"NDC11Code": "55570-0410-12",
"ProductNDC": "55570-410",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sodium Carbonate Anhydrous",
"DosageFormName": "GRANULE",
"StartMarketingDate": "20080313",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Jost Chemical Co.",
"SubstanceName": "SODIUM CARBONATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "13-MAR-08"
},
{
"NDCCode": "55570-410-13",
"PackageDescription": "25 kg in 1 DRUM (55570-410-13) ",
"NDC11Code": "55570-0410-13",
"ProductNDC": "55570-410",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sodium Carbonate Anhydrous",
"DosageFormName": "GRANULE",
"StartMarketingDate": "20080313",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Jost Chemical Co.",
"SubstanceName": "SODIUM CARBONATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "13-MAR-08"
},
{
"NDCCode": "58980-410-25",
"PackageDescription": "25 SUPPOSITORY in 1 JAR (58980-410-25) ",
"NDC11Code": "58980-0410-25",
"ProductNDC": "58980-410",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stratuscare Adult Glycerin",
"NonProprietaryName": "Glycerin",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20140530",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Stratus Pharmaceuticals",
"SubstanceName": "GLYCERIN",
"StrengthNumber": "2",
"StrengthUnit": "g/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140530",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of occasional constipation (irregularity). generally produces bowel movement in ¼ to 1 hour."
},
{
"NDCCode": "63307-410-11",
"PackageDescription": "25 g in 1 BOTTLE (63307-410-11)",
"NDC11Code": "63307-0410-11",
"ProductNDC": "63307-410",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Progesterone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20151130",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Total Pharmacy Supply, Inc.",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "63307-410-25",
"PackageDescription": "500 g in 1 BOTTLE (63307-410-25)",
"NDC11Code": "63307-0410-25",
"ProductNDC": "63307-410",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Progesterone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20151130",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Total Pharmacy Supply, Inc.",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "73069-410-17",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-410-17) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0410-17",
"ProductNDC": "73069-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-pigmentation",
"NonProprietaryName": "Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN",
"StrengthNumber": "31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-410-25",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 BOX (73069-410-25) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0410-25",
"ProductNDC": "73069-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-pigmentation",
"NonProprietaryName": "Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN",
"StrengthNumber": "31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-410-27",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-410-27) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0410-27",
"ProductNDC": "73069-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-pigmentation",
"NonProprietaryName": "Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN",
"StrengthNumber": "31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-410-37",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-410-37) > 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0410-37",
"ProductNDC": "73069-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-pigmentation",
"NonProprietaryName": "Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN",
"StrengthNumber": "31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-410-47",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-410-47) > 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0410-47",
"ProductNDC": "73069-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-pigmentation",
"NonProprietaryName": "Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN",
"StrengthNumber": "31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-410-57",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-410-57) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0410-57",
"ProductNDC": "73069-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-pigmentation",
"NonProprietaryName": "Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN",
"StrengthNumber": "31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-410-67",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-410-67) > 30 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0410-67",
"ProductNDC": "73069-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-pigmentation",
"NonProprietaryName": "Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN",
"StrengthNumber": "31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-410-77",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-410-77) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0410-77",
"ProductNDC": "73069-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-pigmentation",
"NonProprietaryName": "Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN",
"StrengthNumber": "31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-410-87",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-410-87) > 100 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0410-87",
"ProductNDC": "73069-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-pigmentation",
"NonProprietaryName": "Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN",
"StrengthNumber": "31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "78756-410-25",
"PackageDescription": "250 mL in 1 BOTTLE (78756-410-25) ",
"NDC11Code": "78756-0410-25",
"ProductNDC": "78756-410",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lrv Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "LEROLAV HEALTH LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "72603-104-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (72603-104-01) / 25 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "72603-0104-01",
"ProductNDC": "72603-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclophosphamide",
"NonProprietaryName": "Cyclophosphamide",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS; ORAL",
"StartMarketingDate": "20190510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210046",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "CYCLOPHOSPHAMIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/25mL",
"Status": "Deprecated",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190510",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclophosphamide for injection is an alkylating drug indicated for treatment of: 1 Malignant Diseases: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. (1.1).",
"Description": "Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide, USP is a white crystalline powder with the molecular formula C7H15Cl2N2O2PH2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. Cyclophosphamide for Injection, USP is a sterile white powder available as 500 mg, 1 g, and 2 g strength vials. : 1 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide, USP., 2 1 g vial contains 1069 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide, USP, 3 2 g vial contains 2138 mg cyclophosphamide monohydrate equivalent to 2 g cyclophosphamide, USP."
},
{
"NDCCode": "72603-133-25",
"PackageDescription": "25 VIAL in 1 CARTON (72603-133-25) / 2 mL in 1 VIAL (72603-133-01) ",
"NDC11Code": "72603-0133-25",
"ProductNDC": "72603-133",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203428",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250715",
"SamplePackage": "N",
"IndicationAndUsage": "Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema: Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Molecular Formula: Molecular Weight. C12H11ClN2O5S 330.74. Each mL contains: Furosemide USP 10 mg, Water for Injection q.s., Sodium Chloride for isotonicity, Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3."
},
{
"NDCCode": "72603-139-25",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (72603-139-25) / 2 mL in 1 VIAL, MULTI-DOSE (72603-139-01) ",
"NDC11Code": "72603-0139-25",
"ProductNDC": "72603-139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thiamine",
"NonProprietaryName": "Thiamine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20230420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215692",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "THIAMINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230420",
"SamplePackage": "N",
"IndicationAndUsage": "Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke’s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. Thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. Thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given.",
"Description": "Thiamine Hydrochloride Injection, USP is a sterile solution of thiamine hydrochloride in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration. Each mL contains: Thiamine hydrochloride 100 mg; chlorobutanol anhydrous (chloral derivative) 0.5%; monothioglycerol 0.5%; water for injection, q.s. Sodium hydroxide may have been added for pH adjustment (2.5 to 4.5). Thiamine hydrochloride, or vitamin B1, occurs as white crystals or crystalline powder that usually has a slight characteristic odor. Freely soluble in water; soluble in glycerin; slightly soluble in alcohol; insoluble in ether and benzene. Thiamine is rapidly destroyed in neutral or alkaline solutions but is stable in the dry state. It is reasonably stable to heat in acid solution. The chemical name of thiamine hydrochloride is thiazolium,3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methylchloride, monohydrochloride and it has the following structural formula."
},
{
"NDCCode": "72603-153-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (72603-153-25) / 1 mL in 1 VIAL, SINGLE-DOSE (72603-153-01) ",
"NDC11Code": "72603-0153-25",
"ProductNDC": "72603-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20230708",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217789",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230708",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult PatientsKetorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.",
"Description": "Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color."
},
{
"NDCCode": "72603-161-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (72603-161-25) / 1 mL in 1 VIAL, SINGLE-DOSE (72603-161-01) ",
"NDC11Code": "72603-0161-25",
"ProductNDC": "72603-161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20230708",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217789",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230708",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult PatientsKetorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.",
"Description": "Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color."
},
{
"NDCCode": "72603-172-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (72603-172-25) / 2 mL in 1 VIAL, SINGLE-DOSE (72603-172-01) ",
"NDC11Code": "72603-0172-25",
"ProductNDC": "72603-172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20240426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217789",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240426",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult PatientsKetorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.",
"Description": "Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color."
},
{
"NDCCode": "72603-179-25",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (72603-179-25) / 10 mL in 1 VIAL, MULTI-DOSE (72603-179-01) ",
"NDC11Code": "72603-0179-25",
"ProductNDC": "72603-179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium",
"NonProprietaryName": "Heparin Sodium",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211007",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "HEPARIN SODIUM",
"StrengthNumber": "1000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "Heparin Sodium Injection is indicated for: 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism;, 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease;, 3 Atrial fibrillation with embolization;, 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation);, 5 Prevention of clotting in arterial and cardiac surgery;, 6 Prophylaxis and treatment of peripheral arterial embolism., 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.",
"Description": "Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of heparin sodium (representative subunits). Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium Injection, USP preserved with Benzyl Alcohol is available in the following concentrations per mL. pH 5.0-7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment."
},
{
"NDCCode": "72603-200-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 PACKAGE (72603-200-01) / 25 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "72603-0200-01",
"ProductNDC": "72603-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxorubicin Hydrochloride",
"NonProprietaryName": "Doxorubicin Hydrochloride",
"DosageFormName": "INJECTABLE, LIPOSOMAL",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203263",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "DOXORUBICIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190529",
"SamplePackage": "N",
"IndicationAndUsage": "Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor indicated for: 1 Ovarian cancer: After failure of platinum-based chemotherapy (1.1)., 2 AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy (1.2)., 3 Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy (1.3).",
"Description": "The active ingredient in doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in pegylated liposomes for intravenous use. The chemical name of doxorubicin hydrochloride is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C27H29NO11 HCl and the molecular weight is 579.99. The structural formula is. Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion. Each single-dose vial contains 20 mg or 50 mg doxorubicin hydrochloride, USP at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin) and a pH of 6.5. The pegylated liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine, 1.50 mg as a buffer; hydrochloric acid and/or sodium hydroxide for pH control; and sucrose, 100 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the pegylated liposomes."
}
]
}
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Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc"},{"NDCCode":"73069-410-87","ProprietaryName":"Viatrexx-pigmentation","NonProprietaryName":"Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc"},{"NDCCode":"78756-410-25","ProprietaryName":"Lrv Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"72603-104-01","ProprietaryName":"Cyclophosphamide","NonProprietaryName":"Cyclophosphamide"},{"NDCCode":"72603-133-25","ProprietaryName":"Furosemide","NonProprietaryName":"Furosemide"},{"NDCCode":"72603-139-25","ProprietaryName":"Thiamine","NonProprietaryName":"Thiamine Hydrochloride"},{"NDCCode":"72603-153-25","ProprietaryName":"Ketorolac Tromethamine","NonProprietaryName":"Ketorolac Tromethamine"},{"NDCCode":"72603-161-25","ProprietaryName":"Ketorolac Tromethamine","NonProprietaryName":"Ketorolac Tromethamine"},{"NDCCode":"72603-172-25","ProprietaryName":"Ketorolac Tromethamine","NonProprietaryName":"Ketorolac Tromethamine"},{"NDCCode":"72603-179-25","ProprietaryName":"Heparin Sodium","NonProprietaryName":"Heparin Sodium"},{"NDCCode":"72603-200-01","ProprietaryName":"Doxorubicin Hydrochloride","NonProprietaryName":"Doxorubicin Hydrochloride"}]}
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<NDCList>
<NDC>
<NDCCode>72603-410-25</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (72603-410-25) / 2 mL in 1 VIAL (72603-410-01) </PackageDescription>
<NDC11Code>72603-0410-25</NDC11Code>
<ProductNDC>72603-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL</RouteName>
<StartMarketingDate>20240501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217692</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine hydrochloride injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
<Description>Lidocaine hydrochloride injection, USP is sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS AND USAGE section for specific uses. Lidocaine hydrochloride injection, USP solution contain lidocaine hydrochloride, USP which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine hydrochloride, USP (C14H22N2OHCl) has the following structural formula. Lidocaine hydrochloride injection, USP is a clear, colorless, sterile, nonpyrogenic, isotonic solution containing sodium chloride. The pH of this solution is adjusted to approximately 5.0 to 7.0 with sodium hydroxide and/or hydrochloric acid.</Description>
</NDC>
<NDC>
<NDCCode>11410-410-47</NDCCode>
<PackageDescription>25 mL in 1 BOTTLE, DISPENSING (11410-410-47)</PackageDescription>
<NDC11Code>11410-0410-47</NDC11Code>
<ProductNDC>11410-410</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Jane Seymour Natural Advantage</ProprietaryName>
<ProprietaryNameSuffix>Am Spf 15 All Day Moisture With Ahas</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Oxybenzone, And Octisalate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080508</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Guthy-Renker LLC</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE; OCTISALATE</SubstanceName>
<StrengthNumber>.075; .04; .035</StrengthNumber>
<StrengthUnit>mL/mL; mg/mL; mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>12943-410-01</NDCCode>
<PackageDescription>25 kg in 1 CONTAINER (12943-410-01)</PackageDescription>
<NDC11Code>12943-0410-01</NDC11Code>
<ProductNDC>12943-410</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110525</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>SCORA</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>21130-410-52</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (21130-410-52) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21130-0410-52</NDC11Code>
<ProductNDC>21130-410</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gentle Laxative</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>BETTER LIVING BRANDS LLC.</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. : 1 for relief of occasional constipation and irregularity, 2 this product generally produces bowel movement in 6-12 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-410-25</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (43598-410-25) / 5 VIAL in 1 POUCH (43598-410-05) / 3 mL in 1 VIAL</PackageDescription>
<NDC11Code>43598-0410-25</NDC11Code>
<ProductNDC>43598-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levalbuterol Inhalation</ProprietaryName>
<NonProprietaryName>Levalbuterol Inhalation 0.63mg/3ml</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078171</ApplicationNumber>
<LabelerName>Dr. Reddy�s Laboratories, Inc.</LabelerName>
<SubstanceName>LEVALBUTEROL</SubstanceName>
<StrengthNumber>.63</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
<Description>Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg (0.0103%) of Levalbuterol (as 0.36 mg of levalbuterol HCl) or 0.63 mg (0.021%) of levalbuterol (as 0.73 mg of levalbuterol HCl) or 1.25 mg (0.042%) of levalbuterol (as 1.44 mg of levalbuterol HCl), edetate disodium as a chelating agent, sodium chloride to adjust tonicity, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5).</Description>
</NDC>
<NDC>
<NDCCode>43744-410-25</NDCCode>
<PackageDescription>25 g in 1 DRUM (43744-410-25)</PackageDescription>
<NDC11Code>43744-0410-25</NDC11Code>
<ProductNDC>43744-410</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Flucytosine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130110</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>FLUCYTOSINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>53329-410-59</NDCCode>
<PackageDescription>25 PACKET in 1 BOX (53329-410-59) / 1 APPLICATOR in 1 PACKET / 1.4 g in 1 APPLICATOR</PackageDescription>
<NDC11Code>53329-0410-59</NDC11Code>
<ProductNDC>53329-410</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mediplast</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>PLASTER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M030</ApplicationNumber>
<LabelerName>Medline Industries, LP</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the removal of corns and calluses. Relieves pain by removing corns and calluses. for the removal of common warts. The common wart is easily recognized by the rough ‘cauliflower-like’ appearance of the surface. for the removal of plantar warts on the bottom of the foot. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55570-410-12</NDCCode>
<PackageDescription>25 kg in 1 BOX (55570-410-12) </PackageDescription>
<NDC11Code>55570-0410-12</NDC11Code>
<ProductNDC>55570-410</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sodium Carbonate Anhydrous</NonProprietaryName>
<DosageFormName>GRANULE</DosageFormName>
<StartMarketingDate>20080313</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Jost Chemical Co.</LabelerName>
<SubstanceName>SODIUM CARBONATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-MAR-08</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>55570-410-13</NDCCode>
<PackageDescription>25 kg in 1 DRUM (55570-410-13) </PackageDescription>
<NDC11Code>55570-0410-13</NDC11Code>
<ProductNDC>55570-410</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sodium Carbonate Anhydrous</NonProprietaryName>
<DosageFormName>GRANULE</DosageFormName>
<StartMarketingDate>20080313</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Jost Chemical Co.</LabelerName>
<SubstanceName>SODIUM CARBONATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-MAR-08</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>58980-410-25</NDCCode>
<PackageDescription>25 SUPPOSITORY in 1 JAR (58980-410-25) </PackageDescription>
<NDC11Code>58980-0410-25</NDC11Code>
<ProductNDC>58980-410</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stratuscare Adult Glycerin</ProprietaryName>
<NonProprietaryName>Glycerin</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20140530</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Stratus Pharmaceuticals</LabelerName>
<SubstanceName>GLYCERIN</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of occasional constipation (irregularity). generally produces bowel movement in ¼ to 1 hour.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63307-410-11</NDCCode>
<PackageDescription>25 g in 1 BOTTLE (63307-410-11)</PackageDescription>
<NDC11Code>63307-0410-11</NDC11Code>
<ProductNDC>63307-410</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20151130</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Total Pharmacy Supply, Inc.</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63307-410-25</NDCCode>
<PackageDescription>500 g in 1 BOTTLE (63307-410-25)</PackageDescription>
<NDC11Code>63307-0410-25</NDC11Code>
<ProductNDC>63307-410</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20151130</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Total Pharmacy Supply, Inc.</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>73069-410-17</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-410-17) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0410-17</NDC11Code>
<ProductNDC>73069-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-pigmentation</ProprietaryName>
<NonProprietaryName>Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-410-25</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 BOX (73069-410-25) > 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0410-25</NDC11Code>
<ProductNDC>73069-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-pigmentation</ProprietaryName>
<NonProprietaryName>Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-410-27</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-410-27) > 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0410-27</NDC11Code>
<ProductNDC>73069-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-pigmentation</ProprietaryName>
<NonProprietaryName>Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-410-37</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-410-37) > 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0410-37</NDC11Code>
<ProductNDC>73069-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-pigmentation</ProprietaryName>
<NonProprietaryName>Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-410-47</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-410-47) > 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0410-47</NDC11Code>
<ProductNDC>73069-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-pigmentation</ProprietaryName>
<NonProprietaryName>Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-410-57</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-410-57) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0410-57</NDC11Code>
<ProductNDC>73069-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-pigmentation</ProprietaryName>
<NonProprietaryName>Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-410-67</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-410-67) > 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0410-67</NDC11Code>
<ProductNDC>73069-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-pigmentation</ProprietaryName>
<NonProprietaryName>Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-410-77</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-410-77) > 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0410-77</NDC11Code>
<ProductNDC>73069-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-pigmentation</ProprietaryName>
<NonProprietaryName>Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-410-87</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-410-87) > 100 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0410-87</NDC11Code>
<ProductNDC>73069-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-pigmentation</ProprietaryName>
<NonProprietaryName>Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>78756-410-25</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE (78756-410-25) </PackageDescription>
<NDC11Code>78756-0410-25</NDC11Code>
<ProductNDC>78756-410</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lrv Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>LEROLAV HEALTH LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72603-104-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (72603-104-01) / 25 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>72603-0104-01</NDC11Code>
<ProductNDC>72603-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclophosphamide</ProprietaryName>
<NonProprietaryName>Cyclophosphamide</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20190510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210046</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>CYCLOPHOSPHAMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/25mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclophosphamide for injection is an alkylating drug indicated for treatment of: 1 Malignant Diseases: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. (1.1).</IndicationAndUsage>
<Description>Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide, USP is a white crystalline powder with the molecular formula C7H15Cl2N2O2PH2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. Cyclophosphamide for Injection, USP is a sterile white powder available as 500 mg, 1 g, and 2 g strength vials. : 1 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide, USP., 2 1 g vial contains 1069 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide, USP, 3 2 g vial contains 2138 mg cyclophosphamide monohydrate equivalent to 2 g cyclophosphamide, USP.</Description>
</NDC>
<NDC>
<NDCCode>72603-133-25</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (72603-133-25) / 2 mL in 1 VIAL (72603-133-01) </PackageDescription>
<NDC11Code>72603-0133-25</NDC11Code>
<ProductNDC>72603-133</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203428</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema: Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.</IndicationAndUsage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Molecular Formula: Molecular Weight. C12H11ClN2O5S 330.74. Each mL contains: Furosemide USP 10 mg, Water for Injection q.s., Sodium Chloride for isotonicity, Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3.</Description>
</NDC>
<NDC>
<NDCCode>72603-139-25</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (72603-139-25) / 2 mL in 1 VIAL, MULTI-DOSE (72603-139-01) </PackageDescription>
<NDC11Code>72603-0139-25</NDC11Code>
<ProductNDC>72603-139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thiamine</ProprietaryName>
<NonProprietaryName>Thiamine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20230420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215692</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>THIAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke’s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. Thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. Thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given.</IndicationAndUsage>
<Description>Thiamine Hydrochloride Injection, USP is a sterile solution of thiamine hydrochloride in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration. Each mL contains: Thiamine hydrochloride 100 mg; chlorobutanol anhydrous (chloral derivative) 0.5%; monothioglycerol 0.5%; water for injection, q.s. Sodium hydroxide may have been added for pH adjustment (2.5 to 4.5). Thiamine hydrochloride, or vitamin B1, occurs as white crystals or crystalline powder that usually has a slight characteristic odor. Freely soluble in water; soluble in glycerin; slightly soluble in alcohol; insoluble in ether and benzene. Thiamine is rapidly destroyed in neutral or alkaline solutions but is stable in the dry state. It is reasonably stable to heat in acid solution. The chemical name of thiamine hydrochloride is thiazolium,3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methylchloride, monohydrochloride and it has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>72603-153-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (72603-153-25) / 1 mL in 1 VIAL, SINGLE-DOSE (72603-153-01) </PackageDescription>
<NDC11Code>72603-0153-25</NDC11Code>
<ProductNDC>72603-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20230708</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217789</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230708</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult PatientsKetorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.</IndicationAndUsage>
<Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color.</Description>
</NDC>
<NDC>
<NDCCode>72603-161-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (72603-161-25) / 1 mL in 1 VIAL, SINGLE-DOSE (72603-161-01) </PackageDescription>
<NDC11Code>72603-0161-25</NDC11Code>
<ProductNDC>72603-161</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20230708</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217789</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230708</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult PatientsKetorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.</IndicationAndUsage>
<Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color.</Description>
</NDC>
<NDC>
<NDCCode>72603-172-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (72603-172-25) / 2 mL in 1 VIAL, SINGLE-DOSE (72603-172-01) </PackageDescription>
<NDC11Code>72603-0172-25</NDC11Code>
<ProductNDC>72603-172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20240426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217789</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult PatientsKetorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.</IndicationAndUsage>
<Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color.</Description>
</NDC>
<NDC>
<NDCCode>72603-179-25</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (72603-179-25) / 10 mL in 1 VIAL, MULTI-DOSE (72603-179-01) </PackageDescription>
<NDC11Code>72603-0179-25</NDC11Code>
<ProductNDC>72603-179</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium</ProprietaryName>
<NonProprietaryName>Heparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211007</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>HEPARIN SODIUM</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Heparin Sodium Injection is indicated for: 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism;, 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease;, 3 Atrial fibrillation with embolization;, 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation);, 5 Prevention of clotting in arterial and cardiac surgery;, 6 Prophylaxis and treatment of peripheral arterial embolism., 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.</IndicationAndUsage>
<Description>Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of heparin sodium (representative subunits). Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium Injection, USP preserved with Benzyl Alcohol is available in the following concentrations per mL. pH 5.0-7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>72603-200-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 PACKAGE (72603-200-01) / 25 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>72603-0200-01</NDC11Code>
<ProductNDC>72603-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxorubicin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxorubicin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTABLE, LIPOSOMAL</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203263</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>DOXORUBICIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor indicated for: 1 Ovarian cancer: After failure of platinum-based chemotherapy (1.1)., 2 AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy (1.2)., 3 Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy (1.3).</IndicationAndUsage>
<Description>The active ingredient in doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in pegylated liposomes for intravenous use. The chemical name of doxorubicin hydrochloride is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C27H29NO11 HCl and the molecular weight is 579.99. The structural formula is. Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion. Each single-dose vial contains 20 mg or 50 mg doxorubicin hydrochloride, USP at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin) and a pH of 6.5. The pegylated liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine, 1.50 mg as a buffer; hydrochloric acid and/or sodium hydroxide for pH control; and sucrose, 100 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the pegylated liposomes.</Description>
</NDC>
</NDCList>