{
"NDC": [
{
"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": "85477-322-30",
"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": "85477-606-30",
"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": "85477-610-30",
"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": "85477-623-30",
"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": "10544-523-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (10544-523-30)",
"NDC11Code": "10544-0523-30",
"ProductNDC": "10544-523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone",
"NonProprietaryName": "Spironolactone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091426",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "SPIRONOLACTONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Spironolactone tablets, USP are indicated in the management of. Primary hyperaldosteronism for: : 1 Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial., 2 Short-term preoperative treatment of patients with primary hyperaldosteronism., 3 Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery., 4 Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism).",
"Description": "Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ- lactone acetate, which has the following structural formula. Spironolactone, USP is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, corn starch, croscarmellose sodium, flavor, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide, and triacetin. The 50 mg tablet also contains D&C yellow # 10 and FD&C yellow # 6."
},
{
"NDCCode": "16590-523-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (16590-523-30)",
"NDC11Code": "16590-0523-30",
"ProductNDC": "16590-523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sucralfate",
"NonProprietaryName": "Sucralfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074415",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "SUCRALFATE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Tablets for oral administration contain 1 g of sucralfate. Also contain: povidone, magnesium stearate, and colloidal silicon dioxide. Therapeutic category: antiulcer. Sucralfate is only minimally absorbed from the gastrointestinal tract. The small amounts of the sulfated disaccharide that are absorbed are excreted primarily in the urine. Although the mechanism of sucralfate’s ability to accelerate healing of duodenal ulcers remains to be fully defined, it is known that it exerts its effect through a local, rather than systemic, action. The following observations also appear pertinent: 1 Studies in human subjects and with animal models of ulcer disease have shown that sucralfate forms an ulcer-adherent complex with proteinaceous exudate at the ulcer site. , 2 In vitro, a sucralfate-albumin film provides a barrier to diffusion of hydrogen ions. , 3 In human subjects, sucralfate given in doses recommended for ulcer therapy inhibits pepsin activity in gastric juice by 32%. , 4 In vitro, sucralfate adsorbs bile salts. ."
},
{
"NDCCode": "21695-523-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (21695-523-30)",
"NDC11Code": "21695-0523-30",
"ProductNDC": "21695-523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19860212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070756",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Indomethacin and other treatment options before deciding to use Indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease., 2 Moderate to severe ankylosing spondylitis., 3 Moderate to severe osteoarthritis., 4 Acute painful shoulder (bursitis and/or tendinitis)., 5 Acute gouty arthritis.",
"Description": "Indomethacin is available in 25 mg and 50 mg capsules for oral administration. Inactive ingredients include: black iron oxide, corn starch, D&C Yellow No. 10, FD&C Green No. 3, gelatin, lactose monohydrate, lecithin, propylene glycol, shellac, silicon dioxide, stearic acid, and titanium dioxide. May also contain: D&C Red No. 7 calcium lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, and sodium lauryl sulfate. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. Indomethacin is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The structural formula is. C19H16CINO4 M.W.357.79."
},
{
"NDCCode": "24236-523-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (24236-523-02) ",
"NDC11Code": "24236-0523-02",
"ProductNDC": "24236-523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074342",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "33342-523-07",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-523-07) ",
"NDC11Code": "33342-0523-07",
"ProductNDC": "33342-523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218744",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230623",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules is indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3¬ (acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: acetyl tributyl citrate, Ethyl Cellulose, hydroxypropyl methyl cellulose (Methocel E3 Premium LV), hydroxypropyl methyl cellulose (Methocel E5 Premium LV), microcrystalline cellulose, Talc. The capsule shells contain FD&C Blue #1, gelatin and titanium dioxide black iron oxide (300 mg). The capsules are imprinted with black TekPrint TM SW-0012 White Ink or TekPrint TM SB-6018 Blue Ink which contains FD & C Blue # 2 Aluminum Lake - E 132, potassium hydroxide, propylene glycol, titanium Dioxide and shellac. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "41250-523-39",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (41250-523-39) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "41250-0523-39",
"ProductNDC": "41250-523",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076301",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170712",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<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>85477-322-30</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>85477-606-30</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>85477-610-30</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>85477-623-30</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>10544-523-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (10544-523-30)</PackageDescription>
<NDC11Code>10544-0523-30</NDC11Code>
<ProductNDC>10544-523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spironolactone</ProprietaryName>
<NonProprietaryName>Spironolactone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091426</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>SPIRONOLACTONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Spironolactone tablets, USP are indicated in the management of. Primary hyperaldosteronism for: : 1 Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial., 2 Short-term preoperative treatment of patients with primary hyperaldosteronism., 3 Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery., 4 Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism).</IndicationAndUsage>
<Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ- lactone acetate, which has the following structural formula. Spironolactone, USP is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, corn starch, croscarmellose sodium, flavor, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide, and triacetin. The 50 mg tablet also contains D&C yellow # 10 and FD&C yellow # 6.</Description>
</NDC>
<NDC>
<NDCCode>16590-523-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (16590-523-30)</PackageDescription>
<NDC11Code>16590-0523-30</NDC11Code>
<ProductNDC>16590-523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sucralfate</ProprietaryName>
<NonProprietaryName>Sucralfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074415</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>SUCRALFATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Tablets for oral administration contain 1 g of sucralfate. Also contain: povidone, magnesium stearate, and colloidal silicon dioxide. Therapeutic category: antiulcer. Sucralfate is only minimally absorbed from the gastrointestinal tract. The small amounts of the sulfated disaccharide that are absorbed are excreted primarily in the urine. Although the mechanism of sucralfate’s ability to accelerate healing of duodenal ulcers remains to be fully defined, it is known that it exerts its effect through a local, rather than systemic, action. The following observations also appear pertinent: 1 Studies in human subjects and with animal models of ulcer disease have shown that sucralfate forms an ulcer-adherent complex with proteinaceous exudate at the ulcer site. , 2 In vitro, a sucralfate-albumin film provides a barrier to diffusion of hydrogen ions. , 3 In human subjects, sucralfate given in doses recommended for ulcer therapy inhibits pepsin activity in gastric juice by 32%. , 4 In vitro, sucralfate adsorbs bile salts. .</Description>
</NDC>
<NDC>
<NDCCode>21695-523-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (21695-523-30)</PackageDescription>
<NDC11Code>21695-0523-30</NDC11Code>
<ProductNDC>21695-523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070756</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Indomethacin and other treatment options before deciding to use Indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease., 2 Moderate to severe ankylosing spondylitis., 3 Moderate to severe osteoarthritis., 4 Acute painful shoulder (bursitis and/or tendinitis)., 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin is available in 25 mg and 50 mg capsules for oral administration. Inactive ingredients include: black iron oxide, corn starch, D&C Yellow No. 10, FD&C Green No. 3, gelatin, lactose monohydrate, lecithin, propylene glycol, shellac, silicon dioxide, stearic acid, and titanium dioxide. May also contain: D&C Red No. 7 calcium lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, and sodium lauryl sulfate. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. Indomethacin is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The structural formula is. C19H16CINO4 M.W.357.79.</Description>
</NDC>
<NDC>
<NDCCode>24236-523-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (24236-523-02) </PackageDescription>
<NDC11Code>24236-0523-02</NDC11Code>
<ProductNDC>24236-523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074342</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>33342-523-07</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-523-07) </PackageDescription>
<NDC11Code>33342-0523-07</NDC11Code>
<ProductNDC>33342-523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230623</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218744</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules is indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3¬ (acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: acetyl tributyl citrate, Ethyl Cellulose, hydroxypropyl methyl cellulose (Methocel E3 Premium LV), hydroxypropyl methyl cellulose (Methocel E5 Premium LV), microcrystalline cellulose, Talc. The capsule shells contain FD&C Blue #1, gelatin and titanium dioxide black iron oxide (300 mg). The capsules are imprinted with black TekPrint TM SW-0012 White Ink or TekPrint TM SB-6018 Blue Ink which contains FD & C Blue # 2 Aluminum Lake - E 132, potassium hydroxide, propylene glycol, titanium Dioxide and shellac. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>41250-523-39</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (41250-523-39) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>41250-0523-39</NDC11Code>
<ProductNDC>41250-523</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076301</ApplicationNumber>
<LabelerName>Meijer Distribution Inc</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>