{
"NDC": [
{
"NDCCode": "85477-610-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (85477-610-30) ",
"NDC11Code": "85477-0610-30",
"ProductNDC": "85477-610",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lumavex",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20251015",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "THIAMINE HYDROCHLORIDE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; ASCORBIC ACID; PANTOTHENIC ACID; RIBOFLAVIN; FOLIC ACID; METHYLCOBALAMIN",
"StrengthNumber": "5; 35.7; 25; 65; 20; 5; 1.67; .5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251015",
"SamplePackage": "N",
"IndicationAndUsage": "Lumavex is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a subuoptimal nutritional status in patients where advanced folate and maintenance of good health is needed.",
"Description": "Lumavex is a prescription multivitamin/multimineral dietary supplement with 1mg Folic Acid."
},
{
"NDCCode": "85477-322-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (85477-322-30) ",
"NDC11Code": "85477-0322-30",
"ProductNDC": "85477-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Embriva",
"NonProprietaryName": "Ascorbic Acid, Cholecalciferol, Thiamine, Pyridoxal Phosphate, Folic Acid, Methylcobalamin, Calcium Carbonate, Ferrous Gluconate, Potassium Iodide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250808",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "PYRIDOXAL PHOSPHATE ANHYDROUS; POTASSIUM IODIDE; ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE; FOLIC ACID; METHYLCOBALAMIN; CALCIUM CARBONATE; FERROUS GLUCONATE",
"StrengthNumber": "2.5; .15; 125; .0125; 1.4; 1; 1; 200; 13",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250808",
"SamplePackage": "N",
"IndicationAndUsage": "Prenatal and Postnatal prescriptive Folic Acid.",
"Description": "Each Tablet Contains. Amount per Tablet. Thiamine (Vitamin B-1) (from Thiamine Mononitrate) ................. 1.4 mg. Ascorbic Acid...................... ......................................................... 125 mg. Folic Acid ....................................................................................... 1 mg. Colecalciferol ............................................................................. .0125 mg. Pyridoxal Phosphate Anhydrous ................................................. 2.5 mg. Methylcobalamin.................. ........................................................ 1 mg. Calcium Carbonate ................................................................... 200 mg. Ferrous Gluconate ..................................................................... 13 mg. Potassium Iodide........................................................................ .15 mg. Other ingredients: magnesium stearate, microcrystalline cellulose, silicone dioxide."
},
{
"NDCCode": "85477-325-29",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (85477-325-29) ",
"NDC11Code": "85477-0325-29",
"ProductNDC": "85477-325",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidospra",
"NonProprietaryName": "Lidospra",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260825",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "41.2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260825",
"SamplePackage": "N",
"IndicationAndUsage": "LidoSpra is indicated for topical analgesia and for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, and rashes due to poison ivy, poison oak, or poison sumac, or as directed by a healthcare provider.",
"Description": "LidoSpra is a topical spray containing Lidocaine 4.12%."
},
{
"NDCCode": "85477-331-01",
"PackageDescription": "30 mL in 1 BOTTLE, WITH APPLICATOR (85477-331-01) ",
"NDC11Code": "85477-0331-01",
"ProductNDC": "85477-331",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tolfyra",
"NonProprietaryName": "Tolnaftate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "TOLNAFTATE",
"StrengthNumber": ".3",
"StrengthUnit": "g/30mL",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260501",
"SamplePackage": "N",
"IndicationAndUsage": "■ for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis). ■ relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions. ■ for the prevention of most Athlete’s foot with daily use. ■ eliminates fungus on fingers, toes, and around the nails. ■ eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush."
},
{
"NDCCode": "85477-503-30",
"PackageDescription": "1 TABLET in 1 BOTTLE (85477-503-30) ",
"NDC11Code": "85477-0503-30",
"ProductNDC": "85477-503",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metavex",
"NonProprietaryName": "Metavex",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "CHOLECALCIFEROL; FOLIC ACID; BLUE AGAVE INULIN (AGAVE TEQUILANA); ELM; ALOE FEROX LEAF; RHAMNUS CATHARTICA BARK",
"StrengthNumber": ".125; 1; 500; 425; 225; 135",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260101",
"SamplePackage": "N",
"IndicationAndUsage": "Metavex is indicated as a prescription dietary supplement for the dietary management of individuals with metabolic health needs where folic acid supplementation is appropriate. Administration: Take two (2) tablets daily with a 12-ounce glass of water, or as directed by a licensed healthcare practitioner.",
"Description": "Metavex is a prescription folic acid–containing dietary supplement intended to support metabolic health. Each tablet contains a combination of vitamins, minerals, and botanical ingredients formulated to provide nutritional support."
},
{
"NDCCode": "85477-511-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (85477-511-30) ",
"NDC11Code": "85477-0511-30",
"ProductNDC": "85477-511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folartex",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260223",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; MAGNESIUM OXIDE; FERROUS BISGLYCINATE; POTASSIUM IODIDE",
"StrengthNumber": "300; 60; 10; 4.5; 26; .28; 1.67; .013; 80; 25; 20; .15",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260223",
"SamplePackage": "N",
"IndicationAndUsage": "Folarex is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.",
"Description": "Folarex is a prescription multivitamin/multimineral dietary supplement. Other Ingredients: Microcrysta line Ce lulose, Maltodextrin, Croscarme lose Sodium, Silcon Dioxide, Stearic Acid, Magnesium Stearate, FiIm Coating (Hydroxypropyl Methylce lulose, Polyethylene Glycol, Titanium Dioxide, FD&C Blue# 1."
},
{
"NDCCode": "85477-513-30",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE (85477-513-30) ",
"NDC11Code": "85477-0513-30",
"ProductNDC": "85477-513",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitavera",
"NonProprietaryName": "Vitavera",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20260407",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; VITAMIN D; ALPHA-TOCOPHEROL ACETATE; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; LEVOMEFOLIC ACID; METHYLCOBALAMIN",
"StrengthNumber": "2500; 30; 30; 400; 15; 1; 1; 13; 1; 1000; 4",
"StrengthUnit": "[iU]/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260407",
"SamplePackage": "N",
"IndicationAndUsage": "Vitavera is indicated to provide supplemental amounts of essential vitamins including Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate. It is intended to supplement the diet and help prevent nutritional deficiencies. Formulated for use in patients requiring vitamin supplementation as directed by a licensed healthcare practitioner.",
"Description": "Vitavera is a chewable multivitamin dietary supplement containing essential vitamins including Vitamins A, C, D, E, B-complex vitamins, and folate. It is formulated to support general nutritional supplementation and overall health."
},
{
"NDCCode": "85477-523-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (85477-523-30) ",
"NDC11Code": "85477-0523-30",
"ProductNDC": "85477-523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folyra",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; MAGNESIUM OXIDE; FERROUS BISGLYCINATE; POTASSIUM IODIDE",
"StrengthNumber": "300; 60; 10; 4.5; 26; .28; 1.67; .013; 80; 25; 20; .15",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260101",
"SamplePackage": "N",
"IndicationAndUsage": "Folyra is a prescription multivitamin/multimineral dietary supplement indicated for the clinical dietary management of patients with suboptimal nutritional status requiring supplementation of folate and B vitamins, under physician supervision.",
"Description": "Folyra is a prescription multivitamin/multimineral dietary supplement."
},
{
"NDCCode": "85477-606-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (85477-606-30) ",
"NDC11Code": "85477-0606-30",
"ProductNDC": "85477-606",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Virexa",
"NonProprietaryName": "Vitamin C, Vitamin D3, Vitamin B1, Vitamin B6, Vitamin B12, Folic Acid, Nadh, Ubiquinone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250901",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE HCL; PYRIDOXAL PHOSPHATE ANHYDROUS; FOLIC ACID; METHYLCOBALAMIN; NICOTINAMIDE ADENINE DINUCLEOTIDE; UBIQUINONE",
"StrengthNumber": "125; 12.5; 25; 125; 1.667; 1; 5; 50",
"StrengthUnit": "mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Virexa is a multivitamin with folic acid dispensed by prescription only.",
"Description": "Active Ingredients: VItamin C, Vitamin D3, Vitamin B1, Vitamin B6, Vitamin B12, Folic Acid, NADH, Ubiquinone. Inactive Ingredients: Microcrystalline Cellulose, Pregeleatinized Starch, Coating (Beta-Carotene, Titanium Dioxide, Hypromellose, Polyvinyl Alcohol, Polyethylene Glycol, Talc), Croscarmellose Sodium, Silica, Silicon Dioxide, Hydroxypropyl Cellulose, Magnesium Stearate."
},
{
"NDCCode": "85477-623-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (85477-623-30) ",
"NDC11Code": "85477-0623-30",
"ProductNDC": "85477-623",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lunavira",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20251229",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "THIAMINE HYDROCHLORIDE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; ASCORBIC ACID; PANTOTHENIC ACID; RIBOFLAVIN; FOLIC ACID; METHYLCOBALAMIN",
"StrengthNumber": "5; 35.7; 25; 65; 20; 5; 1; .5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251229",
"SamplePackage": "N",
"Description": "Lunavira is a prescription multivitamin/multimineral dietary supplement with 1mg Folic Acid."
},
{
"NDCCode": "85477-710-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (85477-710-30) ",
"NDC11Code": "85477-0710-30",
"ProductNDC": "85477-710",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bionara Ultra",
"NonProprietaryName": "Probiotic Dietary Supplement Capsules",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260223",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "LACTOBACILLUS ACIDOPHILUS LA 14; BIFIDOBACTERIUM ANIMALIS LACTIS BL04; LACTIPLANTIBACILLUS PLANTARUM; LACTICASEIBACILLUS PARACASEI LPC-37; LESSONIA NIGRESCENS; BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES",
"StrengthNumber": "410; 410; 410; 410; 25; 10",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260223",
"SamplePackage": "N",
"IndicationAndUsage": "Bionara Ultra is a prescription probiotic supplement intended to support gastrointestinal health and maintain normal intestinal flora balance. Dispensed by prescription under medical supervision.",
"Description": "Bionara Ultra is a prescription probiotic dietary supplement containing a proprietary blend of probiotic bacteria providing 60 billion CFU per serving (2 capsules), combined with prebiotic and polysaccharide support ingredients. Each serving (2 capsules) contains 820 mg of proprietary probiotic blend delivering 60 billion CFU, including: 1 MATREK® (Bi-Pass Technology), 2 Lactobacillus acidophilus (La-14), 3 Bifidobacterium lactis (Bl-04), 4 Lactobacillus plantarum (Lp-115), 5 Lactobacillus paracasei (Lpc-37)."
},
{
"NDCCode": "85477-711-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (85477-711-30) ",
"NDC11Code": "85477-0711-30",
"ProductNDC": "85477-711",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Microvara",
"NonProprietaryName": "Probiotic Dietary Supplement",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260223",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "LACTOBACILLUS ACIDOPHILUS; LACTIPLANTIBACILLUS PLANTARUM; LACTICASEIBACILLUS RHAMNOSUS; LIMOSILACTOBACILLUS FERMENTUM; LIMOSILACTOBACILLUS REUTERI; LESSONIA NIGRESCENS",
"StrengthNumber": "217; 217; 217; 217; 217; 20",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260223",
"SamplePackage": "N",
"IndicationAndUsage": "Microvara is indicated as a probiotic dietary supplement to support digestive health and maintain normal intestinal flora. It is dispensed by prescription and intended for use under medical supervision as part of a dietary supplementation plan.",
"Description": "Microvara is a prescription-dispensed oral probiotic dietary supplement formulated to support gastrointestinal health and promote balance of normal intestinal microflora. Each serving (two capsules) provides 50 billion colony-forming units (CFU) of beneficial probiotic organisms combined with marine polysaccharide. The proprietary probiotic blend includes: 1 Lactobacillus acidophilus, 2 Lactobacillus plantarum, 3 Lactobacillus rhamnosus, 4 Lactobacillus fermentum, 5 Lactobacillus reuteri."
},
{
"NDCCode": "85477-712-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (85477-712-30) ",
"NDC11Code": "85477-0712-30",
"ProductNDC": "85477-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Probentra",
"NonProprietaryName": "Probiotic Dietary Supplement Capsules",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260223",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "LACTOBACILLUS ACIDOPHILUS LA 14; BIFIDOBACTERIUM ANIMALIS LACTIS BL04; LACTIPLANTIBACILLUS PLANTARUM; LACTICASEIBACILLUS PARACASEI LPC-37; LESSONIA NIGRESCENS; BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES",
"StrengthNumber": "400; 400; 400; 400; 30; 12",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260223",
"SamplePackage": "N",
"IndicationAndUsage": "Probentra is indicated as a probiotic dietary supplement to support digestive health and promote balance of normal intestinal microflora. It is dispensed by prescription and intended for use under medical supervision as part of a dietary supplementation plan. (Notice: no disease treatment claims — this keeps you clean in Rx dietary supplement lane.).",
"Description": "Probentra is a prescription-dispensed oral probiotic dietary supplement formulated to support gastrointestinal health and maintain normal intestinal flora. Each serving (two capsules) delivers 40 billion colony-forming units (CFU) of beneficial probiotic organisms combined with marine polysaccharide and fructooligosaccharide (FOS). The proprietary probiotic blend includes: 1 Lactobacillus acidophilus (La-14®), 2 Bifidobacterium lactis (Bl-04®), 3 Lactobacillus plantarum (Lp-115®), 4 Lactobacillus paracasei (Lpc-37®)."
},
{
"NDCCode": "85477-823-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (85477-823-30) ",
"NDC11Code": "85477-0823-30",
"ProductNDC": "85477-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folvyris",
"NonProprietaryName": "Folate, Vitamin D3",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260501",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "FOLATE SODIUM; VITAMIN D",
"StrengthNumber": "1.7; .125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260501",
"SamplePackage": "N",
"IndicationAndUsage": "Folvyris is for patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency.",
"Description": "Folvyris is an orally administered prescription folate product."
},
{
"NDCCode": "85477-901-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (85477-901-30) ",
"NDC11Code": "85477-0901-30",
"ProductNDC": "85477-901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folaten",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; MAGNESIUM OXIDE; FERROUS BISGLYCINATE; POTASSIUM IODIDE",
"StrengthNumber": "300; 60; 10; 4.5; 26; .28; 1.67; .013; 80; 25; 20; .15",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260101",
"SamplePackage": "N",
"IndicationAndUsage": "Folaten is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a subuoptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.",
"Description": "Folaten is a prescription multivitamin/multimineral dietary supplement."
},
{
"NDCCode": "85477-902-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (85477-902-30) ",
"NDC11Code": "85477-0902-30",
"ProductNDC": "85477-902",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folixia",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250224",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "FERROUS BISGLYCINATE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; MAGNESIUM OXIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-",
"StrengthNumber": "20; .15; 26; .3; 60; .1; .28; 1.67; .013; 80; 25; 4.5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250224",
"SamplePackage": "N",
"IndicationAndUsage": "Folixia is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a subuoptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.",
"Description": "Folixia is a prescription multivitamin/multimineral dietary supplement."
},
{
"NDCCode": "85477-903-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (85477-903-30) ",
"NDC11Code": "85477-0903-30",
"ProductNDC": "85477-903",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nutralyn",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250224",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "FERROUS BISGLYCINATE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; MAGNESIUM OXIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-",
"StrengthNumber": "20; .15; 26; .3; 60; .1; .28; 1.67; .013; 80; 25; 4.5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250224",
"SamplePackage": "N",
"IndicationAndUsage": "Nutralyn is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a subuoptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.",
"Description": "Nutralyn is a prescription multivitamin/multimineral dietary supplement."
},
{
"NDCCode": "85477-904-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (85477-904-30) ",
"NDC11Code": "85477-0904-30",
"ProductNDC": "85477-904",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aflora",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "FERROUS BISGLYCINATE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; MAGNESIUM OXIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-",
"StrengthNumber": "20; .15; 26; .3; 60; .1; .28; 1.67; .013; 80; 25; 4.5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "Aflora is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a subuoptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.",
"Description": "Aflora is a prescription multivitamin/multimineral dietary supplement."
},
{
"NDCCode": "85477-905-30",
"PackageDescription": "227 g in 1 BOTTLE (85477-905-30) ",
"NDC11Code": "85477-0905-30",
"ProductNDC": "85477-905",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Urea 41%",
"NonProprietaryName": "Urea",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250611",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "UREA",
"StrengthNumber": "410",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250611",
"SamplePackage": "N",
"IndicationAndUsage": "For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails."
},
{
"NDCCode": "85477-909-30",
"PackageDescription": "227 g in 1 JAR (85477-909-30) ",
"NDC11Code": "85477-0909-30",
"ProductNDC": "85477-909",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dermacure",
"NonProprietaryName": "Urea 41%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250603",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "UREA",
"StrengthNumber": "410",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250911",
"SamplePackage": "N",
"IndicationAndUsage": "For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails."
},
{
"NDCCode": "85477-921-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (85477-921-30) ",
"NDC11Code": "85477-0921-30",
"ProductNDC": "85477-921",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Foltira",
"NonProprietaryName": "Folate, Vitamin D3",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251212",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "FOLATE SODIUM; VITAMIN D",
"StrengthNumber": "1.7; .125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251212",
"SamplePackage": "N",
"IndicationAndUsage": "Foltira is for patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency.",
"Description": "Foltira is an orally administered prescription folate product."
},
{
"NDCCode": "85477-922-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (85477-922-30) ",
"NDC11Code": "85477-0922-30",
"ProductNDC": "85477-922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gestyra",
"NonProprietaryName": "Ascorbic Acid, Cholecalciferol, Thiamine, Pyridoxal Phosphate, Folic Acid, Methylcobalamin, Calcium Carbonate, Ferrous Gluconate, Potassium Iodide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251222",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma LLC",
"SubstanceName": "ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE; PYRIDOXAL PHOSPHATE ANHYDROUS; FOLIC ACID; METHYLCOBALAMIN; CALCIUM CARBONATE; FERROUS GLUCONATE; POTASSIUM IODIDE",
"StrengthNumber": "125; 12.5; 1.4; 2.5; 1; 1000; 200; 13; .15",
"StrengthUnit": "mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251222",
"SamplePackage": "N",
"IndicationAndUsage": "Prenatal and Postnatal prescriptive Folic Acid.",
"Description": "Each Tablet Contains. Amount per Tablet. Vitamin C (as ascorbic acid) ............................................................................... 125 mg. Vitamin D (as cholecalciferol) ............................................................................. 12.5 mcg. Thiamine (as hydrochloride) ............................................................................... 1.4 mg. Vitamin B6 (as pyridoxalSphosphate) ...................................... ....................... 2.5 mg. Folic Acid ............................................................................................................ 1 mg. Vitamin B12 (as methylcobalamin)...................................................................... 1,000 mcg. Calcium (from calcium carbonate) ...................................................................... 200 mg. Iron (as ferrous gluconate) ................................................................................. 13 mg. Iodine (as potassium iodide............................................................................... 150 mcg. OTHER INGREDIENTS: Microcrystalline Cellulose, Magnesium Stearate, Silia, Glycerin, Vanilla Extract."
},
{
"NDCCode": "85477-924-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (85477-924-30) ",
"NDC11Code": "85477-0924-30",
"ProductNDC": "85477-924",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minovia Mini",
"NonProprietaryName": "Minovia Mini",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260624",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE; FOLIC ACID; CYANOCOBALAMIN; FERROUS FUMARATE",
"StrengthNumber": "1000; 100; 1000; 20; 1.67; 100; 27",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; mg/1; mg/1; ug/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260624",
"SamplePackage": "N",
"IndicationAndUsage": "Minovia Mini is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.",
"Description": "Minovia Mini is a prescription multivitamin/multimineral dietary supplement."
},
{
"NDCCode": "85477-925-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (85477-925-30) ",
"NDC11Code": "85477-0925-30",
"ProductNDC": "85477-925",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirexa Mini",
"NonProprietaryName": "Mirexa Mini",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260825",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE; FOLIC ACID; CYANOCOBALAMIN; FERROUS FUMARATE",
"StrengthNumber": "1000; 100; 1000; 20; 1.67; 100; 27",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; mg/1; mg/1; ug/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260825",
"SamplePackage": "N",
"IndicationAndUsage": "Mirexa Mini is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.",
"Description": "Mirexa Mini is a prescription multivitamin/multimineral dietary supplement."
},
{
"NDCCode": "11410-610-29",
"PackageDescription": "1 TUBE in 1 BOX (11410-610-29) > 30 mL in 1 TUBE",
"NDC11Code": "11410-0610-29",
"ProductNDC": "11410-610",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Solution",
"ProprietaryNameSuffix": "Purifying Botanical Peel",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120210",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": ".5",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "13668-610-02",
"PackageDescription": "1 TUBE in 1 CARTON (13668-610-02) / 30 g in 1 TUBE",
"NDC11Code": "13668-0610-02",
"ProductNDC": "13668-610",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin And Triamcinolone Acetonide",
"NonProprietaryName": "Nystatin And Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213142",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "100000; 1",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2023-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200714",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin and triamcinolone acetonide cream USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.",
"Description": "Nystatin and triamcinolone acetonide cream USP for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin USP is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder. Is hygroscopic and is affected by long exposure to light, heat and air. freely soluble in dimethylformamide and in dimethyl sulfoxide; very slightly soluble in methanol, practically insoluble or insoluble in water in alcohol, in n-propyl alcohol, in n-butyl alcohol, in chloroform and in ether. Structural formula. Triamcinolone acetonide USP is designated chemically as 9-fluoro-11ß, 16α, 17, 21-tetrahydroxy pregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder having not more than a slight odour, is practically insoluble in water, and sparingly soluble in dehydrated alcohol, in chloroform, and in methanol. Structural formula. Nystatin and triamcinolone acetonide cream USP is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an aqueous cream base containing aluminium hydroxide gel, ceteareth-15, methylparaben, mono- and di- glycerides, polyoxyl 8 stearate, polysorbate 60, propylparaben, propylene glycol, simethicone emulsion, sorbic acid, noncrystallizing sorbitol solution, titanium dioxide and white petrolatum."
},
{
"NDCCode": "25000-610-03",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (25000-610-03) ",
"NDC11Code": "25000-0610-03",
"ProductNDC": "25000-610",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090723",
"LabelerName": "MARKSANS PHARMA LIMITED",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220527",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain in adults Fibromyalgia in adults and pediatric patients 13 years of age and older Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive Ingredients include sugar spheres (contains sugar and corn starch), hypromellose, glycine, sucrose, talc, hypromellose phthalate, triethyl citrate, gelatin, titanium dioxide, FD&C Blue 2, sodium lauryl sulfate, shellac and iron oxide yellow. The 20 mg capsules also contain black iron oxide and potassium hydroxide. The 60 mg capsules also contain potassium hydroxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "35356-610-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-610-30)",
"NDC11Code": "35356-0610-30",
"ProductNDC": "35356-610",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exalgo",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110314",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021217",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-04-09",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "37000-610-30",
"PackageDescription": "915 mL in 1 BOTTLE, PUMP (37000-610-30)",
"NDC11Code": "37000-0610-30",
"ProductNDC": "37000-610",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dawn",
"ProprietaryNameSuffix": "Direct Foam Citrus Kick",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Procter & Gamble Manufacturing Company",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2014-06-17"
},
{
"NDCCode": "42549-610-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (42549-610-30)",
"NDC11Code": "42549-0610-30",
"ProductNDC": "42549-610",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078206",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.",
"Description": "Oxycodone Hydrochloride Tablets USP are an opioid analgesic. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, stearic acid, D&C Yellow No. 10 (15 mg tablet), and FD&C Blue No. 2 (15 mg and 30 mg tablets). The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27.0 mg, respectively, of oxycodone free base."
}
]
}
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<NDCList>
<NDC>
<NDCCode>85477-610-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (85477-610-30) </PackageDescription>
<NDC11Code>85477-0610-30</NDC11Code>
<ProductNDC>85477-610</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lumavex</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251015</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>THIAMINE HYDROCHLORIDE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; ASCORBIC ACID; PANTOTHENIC ACID; RIBOFLAVIN; FOLIC ACID; METHYLCOBALAMIN</SubstanceName>
<StrengthNumber>5; 35.7; 25; 65; 20; 5; 1.67; .5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lumavex is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a subuoptimal nutritional status in patients where advanced folate and maintenance of good health is needed.</IndicationAndUsage>
<Description>Lumavex is a prescription multivitamin/multimineral dietary supplement with 1mg Folic Acid.</Description>
</NDC>
<NDC>
<NDCCode>85477-322-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (85477-322-30) </PackageDescription>
<NDC11Code>85477-0322-30</NDC11Code>
<ProductNDC>85477-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Embriva</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Cholecalciferol, Thiamine, Pyridoxal Phosphate, Folic Acid, Methylcobalamin, Calcium Carbonate, Ferrous Gluconate, Potassium Iodide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250808</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>PYRIDOXAL PHOSPHATE ANHYDROUS; POTASSIUM IODIDE; ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE; FOLIC ACID; METHYLCOBALAMIN; CALCIUM CARBONATE; FERROUS GLUCONATE</SubstanceName>
<StrengthNumber>2.5; .15; 125; .0125; 1.4; 1; 1; 200; 13</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prenatal and Postnatal prescriptive Folic Acid.</IndicationAndUsage>
<Description>Each Tablet Contains. Amount per Tablet. Thiamine (Vitamin B-1) (from Thiamine Mononitrate) ................. 1.4 mg. Ascorbic Acid...................... ......................................................... 125 mg. Folic Acid ....................................................................................... 1 mg. Colecalciferol ............................................................................. .0125 mg. Pyridoxal Phosphate Anhydrous ................................................. 2.5 mg. Methylcobalamin.................. ........................................................ 1 mg. Calcium Carbonate ................................................................... 200 mg. Ferrous Gluconate ..................................................................... 13 mg. Potassium Iodide........................................................................ .15 mg. Other ingredients: magnesium stearate, microcrystalline cellulose, silicone dioxide.</Description>
</NDC>
<NDC>
<NDCCode>85477-325-29</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (85477-325-29) </PackageDescription>
<NDC11Code>85477-0325-29</NDC11Code>
<ProductNDC>85477-325</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidospra</ProprietaryName>
<NonProprietaryName>Lidospra</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260825</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>41.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LidoSpra is indicated for topical analgesia and for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, and rashes due to poison ivy, poison oak, or poison sumac, or as directed by a healthcare provider.</IndicationAndUsage>
<Description>LidoSpra is a topical spray containing Lidocaine 4.12%.</Description>
</NDC>
<NDC>
<NDCCode>85477-331-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, WITH APPLICATOR (85477-331-01) </PackageDescription>
<NDC11Code>85477-0331-01</NDC11Code>
<ProductNDC>85477-331</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tolfyra</ProprietaryName>
<NonProprietaryName>Tolnaftate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>TOLNAFTATE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>g/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis). ■ relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions. ■ for the prevention of most Athlete’s foot with daily use. ■ eliminates fungus on fingers, toes, and around the nails. ■ eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85477-503-30</NDCCode>
<PackageDescription>1 TABLET in 1 BOTTLE (85477-503-30) </PackageDescription>
<NDC11Code>85477-0503-30</NDC11Code>
<ProductNDC>85477-503</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metavex</ProprietaryName>
<NonProprietaryName>Metavex</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>CHOLECALCIFEROL; FOLIC ACID; BLUE AGAVE INULIN (AGAVE TEQUILANA); ELM; ALOE FEROX LEAF; RHAMNUS CATHARTICA BARK</SubstanceName>
<StrengthNumber>.125; 1; 500; 425; 225; 135</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metavex is indicated as a prescription dietary supplement for the dietary management of individuals with metabolic health needs where folic acid supplementation is appropriate. Administration: Take two (2) tablets daily with a 12-ounce glass of water, or as directed by a licensed healthcare practitioner.</IndicationAndUsage>
<Description>Metavex is a prescription folic acid–containing dietary supplement intended to support metabolic health. Each tablet contains a combination of vitamins, minerals, and botanical ingredients formulated to provide nutritional support.</Description>
</NDC>
<NDC>
<NDCCode>85477-511-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (85477-511-30) </PackageDescription>
<NDC11Code>85477-0511-30</NDC11Code>
<ProductNDC>85477-511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folartex</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260223</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; MAGNESIUM OXIDE; FERROUS BISGLYCINATE; POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>300; 60; 10; 4.5; 26; .28; 1.67; .013; 80; 25; 20; .15</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Folarex is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.</IndicationAndUsage>
<Description>Folarex is a prescription multivitamin/multimineral dietary supplement. Other Ingredients: Microcrysta line Ce lulose, Maltodextrin, Croscarme lose Sodium, Silcon Dioxide, Stearic Acid, Magnesium Stearate, FiIm Coating (Hydroxypropyl Methylce lulose, Polyethylene Glycol, Titanium Dioxide, FD&C Blue# 1.</Description>
</NDC>
<NDC>
<NDCCode>85477-513-30</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (85477-513-30) </PackageDescription>
<NDC11Code>85477-0513-30</NDC11Code>
<ProductNDC>85477-513</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitavera</ProprietaryName>
<NonProprietaryName>Vitavera</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260407</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; VITAMIN D; ALPHA-TOCOPHEROL ACETATE; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; LEVOMEFOLIC ACID; METHYLCOBALAMIN</SubstanceName>
<StrengthNumber>2500; 30; 30; 400; 15; 1; 1; 13; 1; 1000; 4</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitavera is indicated to provide supplemental amounts of essential vitamins including Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate. It is intended to supplement the diet and help prevent nutritional deficiencies. Formulated for use in patients requiring vitamin supplementation as directed by a licensed healthcare practitioner.</IndicationAndUsage>
<Description>Vitavera is a chewable multivitamin dietary supplement containing essential vitamins including Vitamins A, C, D, E, B-complex vitamins, and folate. It is formulated to support general nutritional supplementation and overall health.</Description>
</NDC>
<NDC>
<NDCCode>85477-523-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (85477-523-30) </PackageDescription>
<NDC11Code>85477-0523-30</NDC11Code>
<ProductNDC>85477-523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folyra</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; MAGNESIUM OXIDE; FERROUS BISGLYCINATE; POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>300; 60; 10; 4.5; 26; .28; 1.67; .013; 80; 25; 20; .15</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Folyra is a prescription multivitamin/multimineral dietary supplement indicated for the clinical dietary management of patients with suboptimal nutritional status requiring supplementation of folate and B vitamins, under physician supervision.</IndicationAndUsage>
<Description>Folyra is a prescription multivitamin/multimineral dietary supplement.</Description>
</NDC>
<NDC>
<NDCCode>85477-606-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (85477-606-30) </PackageDescription>
<NDC11Code>85477-0606-30</NDC11Code>
<ProductNDC>85477-606</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Virexa</ProprietaryName>
<NonProprietaryName>Vitamin C, Vitamin D3, Vitamin B1, Vitamin B6, Vitamin B12, Folic Acid, Nadh, Ubiquinone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE HCL; PYRIDOXAL PHOSPHATE ANHYDROUS; FOLIC ACID; METHYLCOBALAMIN; NICOTINAMIDE ADENINE DINUCLEOTIDE; UBIQUINONE</SubstanceName>
<StrengthNumber>125; 12.5; 25; 125; 1.667; 1; 5; 50</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Virexa is a multivitamin with folic acid dispensed by prescription only.</IndicationAndUsage>
<Description>Active Ingredients: VItamin C, Vitamin D3, Vitamin B1, Vitamin B6, Vitamin B12, Folic Acid, NADH, Ubiquinone. Inactive Ingredients: Microcrystalline Cellulose, Pregeleatinized Starch, Coating (Beta-Carotene, Titanium Dioxide, Hypromellose, Polyvinyl Alcohol, Polyethylene Glycol, Talc), Croscarmellose Sodium, Silica, Silicon Dioxide, Hydroxypropyl Cellulose, Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>85477-623-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (85477-623-30) </PackageDescription>
<NDC11Code>85477-0623-30</NDC11Code>
<ProductNDC>85477-623</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lunavira</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251229</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>THIAMINE HYDROCHLORIDE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; ASCORBIC ACID; PANTOTHENIC ACID; RIBOFLAVIN; FOLIC ACID; METHYLCOBALAMIN</SubstanceName>
<StrengthNumber>5; 35.7; 25; 65; 20; 5; 1; .5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Lunavira is a prescription multivitamin/multimineral dietary supplement with 1mg Folic Acid.</Description>
</NDC>
<NDC>
<NDCCode>85477-710-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (85477-710-30) </PackageDescription>
<NDC11Code>85477-0710-30</NDC11Code>
<ProductNDC>85477-710</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bionara Ultra</ProprietaryName>
<NonProprietaryName>Probiotic Dietary Supplement Capsules</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260223</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>LACTOBACILLUS ACIDOPHILUS LA 14; BIFIDOBACTERIUM ANIMALIS LACTIS BL04; LACTIPLANTIBACILLUS PLANTARUM; LACTICASEIBACILLUS PARACASEI LPC-37; LESSONIA NIGRESCENS; BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES</SubstanceName>
<StrengthNumber>410; 410; 410; 410; 25; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bionara Ultra is a prescription probiotic supplement intended to support gastrointestinal health and maintain normal intestinal flora balance. Dispensed by prescription under medical supervision.</IndicationAndUsage>
<Description>Bionara Ultra is a prescription probiotic dietary supplement containing a proprietary blend of probiotic bacteria providing 60 billion CFU per serving (2 capsules), combined with prebiotic and polysaccharide support ingredients. Each serving (2 capsules) contains 820 mg of proprietary probiotic blend delivering 60 billion CFU, including: 1 MATREK® (Bi-Pass Technology), 2 Lactobacillus acidophilus (La-14), 3 Bifidobacterium lactis (Bl-04), 4 Lactobacillus plantarum (Lp-115), 5 Lactobacillus paracasei (Lpc-37).</Description>
</NDC>
<NDC>
<NDCCode>85477-711-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (85477-711-30) </PackageDescription>
<NDC11Code>85477-0711-30</NDC11Code>
<ProductNDC>85477-711</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Microvara</ProprietaryName>
<NonProprietaryName>Probiotic Dietary Supplement</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260223</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>LACTOBACILLUS ACIDOPHILUS; LACTIPLANTIBACILLUS PLANTARUM; LACTICASEIBACILLUS RHAMNOSUS; LIMOSILACTOBACILLUS FERMENTUM; LIMOSILACTOBACILLUS REUTERI; LESSONIA NIGRESCENS</SubstanceName>
<StrengthNumber>217; 217; 217; 217; 217; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Microvara is indicated as a probiotic dietary supplement to support digestive health and maintain normal intestinal flora. It is dispensed by prescription and intended for use under medical supervision as part of a dietary supplementation plan.</IndicationAndUsage>
<Description>Microvara is a prescription-dispensed oral probiotic dietary supplement formulated to support gastrointestinal health and promote balance of normal intestinal microflora. Each serving (two capsules) provides 50 billion colony-forming units (CFU) of beneficial probiotic organisms combined with marine polysaccharide. The proprietary probiotic blend includes: 1 Lactobacillus acidophilus, 2 Lactobacillus plantarum, 3 Lactobacillus rhamnosus, 4 Lactobacillus fermentum, 5 Lactobacillus reuteri.</Description>
</NDC>
<NDC>
<NDCCode>85477-712-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (85477-712-30) </PackageDescription>
<NDC11Code>85477-0712-30</NDC11Code>
<ProductNDC>85477-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Probentra</ProprietaryName>
<NonProprietaryName>Probiotic Dietary Supplement Capsules</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260223</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>LACTOBACILLUS ACIDOPHILUS LA 14; BIFIDOBACTERIUM ANIMALIS LACTIS BL04; LACTIPLANTIBACILLUS PLANTARUM; LACTICASEIBACILLUS PARACASEI LPC-37; LESSONIA NIGRESCENS; BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES</SubstanceName>
<StrengthNumber>400; 400; 400; 400; 30; 12</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Probentra is indicated as a probiotic dietary supplement to support digestive health and promote balance of normal intestinal microflora. It is dispensed by prescription and intended for use under medical supervision as part of a dietary supplementation plan. (Notice: no disease treatment claims — this keeps you clean in Rx dietary supplement lane.).</IndicationAndUsage>
<Description>Probentra is a prescription-dispensed oral probiotic dietary supplement formulated to support gastrointestinal health and maintain normal intestinal flora. Each serving (two capsules) delivers 40 billion colony-forming units (CFU) of beneficial probiotic organisms combined with marine polysaccharide and fructooligosaccharide (FOS). The proprietary probiotic blend includes: 1 Lactobacillus acidophilus (La-14®), 2 Bifidobacterium lactis (Bl-04®), 3 Lactobacillus plantarum (Lp-115®), 4 Lactobacillus paracasei (Lpc-37®).</Description>
</NDC>
<NDC>
<NDCCode>85477-823-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (85477-823-30) </PackageDescription>
<NDC11Code>85477-0823-30</NDC11Code>
<ProductNDC>85477-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folvyris</ProprietaryName>
<NonProprietaryName>Folate, Vitamin D3</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>FOLATE SODIUM; VITAMIN D</SubstanceName>
<StrengthNumber>1.7; .125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Folvyris is for patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency.</IndicationAndUsage>
<Description>Folvyris is an orally administered prescription folate product.</Description>
</NDC>
<NDC>
<NDCCode>85477-901-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (85477-901-30) </PackageDescription>
<NDC11Code>85477-0901-30</NDC11Code>
<ProductNDC>85477-901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folaten</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; MAGNESIUM OXIDE; FERROUS BISGLYCINATE; POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>300; 60; 10; 4.5; 26; .28; 1.67; .013; 80; 25; 20; .15</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Folaten is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a subuoptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.</IndicationAndUsage>
<Description>Folaten is a prescription multivitamin/multimineral dietary supplement.</Description>
</NDC>
<NDC>
<NDCCode>85477-902-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (85477-902-30) </PackageDescription>
<NDC11Code>85477-0902-30</NDC11Code>
<ProductNDC>85477-902</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folixia</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250224</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>FERROUS BISGLYCINATE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; MAGNESIUM OXIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-</SubstanceName>
<StrengthNumber>20; .15; 26; .3; 60; .1; .28; 1.67; .013; 80; 25; 4.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Folixia is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a subuoptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.</IndicationAndUsage>
<Description>Folixia is a prescription multivitamin/multimineral dietary supplement.</Description>
</NDC>
<NDC>
<NDCCode>85477-903-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (85477-903-30) </PackageDescription>
<NDC11Code>85477-0903-30</NDC11Code>
<ProductNDC>85477-903</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nutralyn</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250224</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>FERROUS BISGLYCINATE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; MAGNESIUM OXIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-</SubstanceName>
<StrengthNumber>20; .15; 26; .3; 60; .1; .28; 1.67; .013; 80; 25; 4.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nutralyn is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a subuoptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.</IndicationAndUsage>
<Description>Nutralyn is a prescription multivitamin/multimineral dietary supplement.</Description>
</NDC>
<NDC>
<NDCCode>85477-904-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (85477-904-30) </PackageDescription>
<NDC11Code>85477-0904-30</NDC11Code>
<ProductNDC>85477-904</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aflora</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>FERROUS BISGLYCINATE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; MAGNESIUM OXIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-</SubstanceName>
<StrengthNumber>20; .15; 26; .3; 60; .1; .28; 1.67; .013; 80; 25; 4.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aflora is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a subuoptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.</IndicationAndUsage>
<Description>Aflora is a prescription multivitamin/multimineral dietary supplement.</Description>
</NDC>
<NDC>
<NDCCode>85477-905-30</NDCCode>
<PackageDescription>227 g in 1 BOTTLE (85477-905-30) </PackageDescription>
<NDC11Code>85477-0905-30</NDC11Code>
<ProductNDC>85477-905</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Urea 41%</ProprietaryName>
<NonProprietaryName>Urea</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250611</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>UREA</SubstanceName>
<StrengthNumber>410</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250611</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85477-909-30</NDCCode>
<PackageDescription>227 g in 1 JAR (85477-909-30) </PackageDescription>
<NDC11Code>85477-0909-30</NDC11Code>
<ProductNDC>85477-909</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dermacure</ProprietaryName>
<NonProprietaryName>Urea 41%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250603</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>UREA</SubstanceName>
<StrengthNumber>410</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85477-921-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (85477-921-30) </PackageDescription>
<NDC11Code>85477-0921-30</NDC11Code>
<ProductNDC>85477-921</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Foltira</ProprietaryName>
<NonProprietaryName>Folate, Vitamin D3</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251212</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>FOLATE SODIUM; VITAMIN D</SubstanceName>
<StrengthNumber>1.7; .125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Foltira is for patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency.</IndicationAndUsage>
<Description>Foltira is an orally administered prescription folate product.</Description>
</NDC>
<NDC>
<NDCCode>85477-922-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (85477-922-30) </PackageDescription>
<NDC11Code>85477-0922-30</NDC11Code>
<ProductNDC>85477-922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gestyra</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Cholecalciferol, Thiamine, Pyridoxal Phosphate, Folic Acid, Methylcobalamin, Calcium Carbonate, Ferrous Gluconate, Potassium Iodide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251222</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE; PYRIDOXAL PHOSPHATE ANHYDROUS; FOLIC ACID; METHYLCOBALAMIN; CALCIUM CARBONATE; FERROUS GLUCONATE; POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>125; 12.5; 1.4; 2.5; 1; 1000; 200; 13; .15</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prenatal and Postnatal prescriptive Folic Acid.</IndicationAndUsage>
<Description>Each Tablet Contains. Amount per Tablet. Vitamin C (as ascorbic acid) ............................................................................... 125 mg. Vitamin D (as cholecalciferol) ............................................................................. 12.5 mcg. Thiamine (as hydrochloride) ............................................................................... 1.4 mg. Vitamin B6 (as pyridoxalSphosphate) ...................................... ....................... 2.5 mg. Folic Acid ............................................................................................................ 1 mg. Vitamin B12 (as methylcobalamin)...................................................................... 1,000 mcg. Calcium (from calcium carbonate) ...................................................................... 200 mg. Iron (as ferrous gluconate) ................................................................................. 13 mg. Iodine (as potassium iodide............................................................................... 150 mcg. OTHER INGREDIENTS: Microcrystalline Cellulose, Magnesium Stearate, Silia, Glycerin, Vanilla Extract.</Description>
</NDC>
<NDC>
<NDCCode>85477-924-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (85477-924-30) </PackageDescription>
<NDC11Code>85477-0924-30</NDC11Code>
<ProductNDC>85477-924</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minovia Mini</ProprietaryName>
<NonProprietaryName>Minovia Mini</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260624</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE; FOLIC ACID; CYANOCOBALAMIN; FERROUS FUMARATE</SubstanceName>
<StrengthNumber>1000; 100; 1000; 20; 1.67; 100; 27</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; mg/1; mg/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minovia Mini is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.</IndicationAndUsage>
<Description>Minovia Mini is a prescription multivitamin/multimineral dietary supplement.</Description>
</NDC>
<NDC>
<NDCCode>85477-925-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (85477-925-30) </PackageDescription>
<NDC11Code>85477-0925-30</NDC11Code>
<ProductNDC>85477-925</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirexa Mini</ProprietaryName>
<NonProprietaryName>Mirexa Mini</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260825</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE; FOLIC ACID; CYANOCOBALAMIN; FERROUS FUMARATE</SubstanceName>
<StrengthNumber>1000; 100; 1000; 20; 1.67; 100; 27</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; mg/1; mg/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirexa Mini is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.</IndicationAndUsage>
<Description>Mirexa Mini is a prescription multivitamin/multimineral dietary supplement.</Description>
</NDC>
<NDC>
<NDCCode>11410-610-29</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (11410-610-29) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>11410-0610-29</NDC11Code>
<ProductNDC>11410-610</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Proactiv Solution</ProprietaryName>
<ProprietaryNameSuffix>Purifying Botanical Peel</ProprietaryNameSuffix>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120210</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Guthy-Renker LLC</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13668-610-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (13668-610-02) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>13668-0610-02</NDC11Code>
<ProductNDC>13668-610</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin And Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Nystatin And Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213142</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>NYSTATIN; TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>100000; 1</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin and triamcinolone acetonide cream USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.</IndicationAndUsage>
<Description>Nystatin and triamcinolone acetonide cream USP for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin USP is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder. Is hygroscopic and is affected by long exposure to light, heat and air. freely soluble in dimethylformamide and in dimethyl sulfoxide; very slightly soluble in methanol, practically insoluble or insoluble in water in alcohol, in n-propyl alcohol, in n-butyl alcohol, in chloroform and in ether. Structural formula. Triamcinolone acetonide USP is designated chemically as 9-fluoro-11ß, 16α, 17, 21-tetrahydroxy pregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder having not more than a slight odour, is practically insoluble in water, and sparingly soluble in dehydrated alcohol, in chloroform, and in methanol. Structural formula. Nystatin and triamcinolone acetonide cream USP is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an aqueous cream base containing aluminium hydroxide gel, ceteareth-15, methylparaben, mono- and di- glycerides, polyoxyl 8 stearate, polysorbate 60, propylparaben, propylene glycol, simethicone emulsion, sorbic acid, noncrystallizing sorbitol solution, titanium dioxide and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>25000-610-03</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (25000-610-03) </PackageDescription>
<NDC11Code>25000-0610-03</NDC11Code>
<ProductNDC>25000-610</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090723</ApplicationNumber>
<LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain in adults Fibromyalgia in adults and pediatric patients 13 years of age and older Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive Ingredients include sugar spheres (contains sugar and corn starch), hypromellose, glycine, sucrose, talc, hypromellose phthalate, triethyl citrate, gelatin, titanium dioxide, FD&C Blue 2, sodium lauryl sulfate, shellac and iron oxide yellow. The 20 mg capsules also contain black iron oxide and potassium hydroxide. The 60 mg capsules also contain potassium hydroxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>35356-610-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-610-30)</PackageDescription>
<NDC11Code>35356-0610-30</NDC11Code>
<ProductNDC>35356-610</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Exalgo</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110314</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021217</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-04-09</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>37000-610-30</NDCCode>
<PackageDescription>915 mL in 1 BOTTLE, PUMP (37000-610-30)</PackageDescription>
<NDC11Code>37000-0610-30</NDC11Code>
<ProductNDC>37000-610</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dawn</ProprietaryName>
<ProprietaryNameSuffix>Direct Foam Citrus Kick</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-06-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>42549-610-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42549-610-30)</PackageDescription>
<NDC11Code>42549-0610-30</NDC11Code>
<ProductNDC>42549-610</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070319</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078206</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets USP are an opioid analgesic. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, stearic acid, D&C Yellow No. 10 (15 mg tablet), and FD&C Blue No. 2 (15 mg and 30 mg tablets). The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27.0 mg, respectively, of oxycodone free base.</Description>
</NDC>
</NDCList>