{
"NDC": [
{
"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": "85477-322-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (85477-322-30) ",
"NDC11Code": "85477-0322-30",
"ProductNDC": "85477-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Embriva",
"NonProprietaryName": "Ascorbic Acid, Cholecalciferol, Thiamine, Pyridoxal Phosphate, Folic Acid, Methylcobalamin, Calcium Carbonate, Ferrous Gluconate, Potassium Iodide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250808",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "PYRIDOXAL PHOSPHATE ANHYDROUS; POTASSIUM IODIDE; ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE; FOLIC ACID; METHYLCOBALAMIN; CALCIUM CARBONATE; FERROUS GLUCONATE",
"StrengthNumber": "2.5; .15; 125; .0125; 1.4; 1; 1; 200; 13",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250808",
"SamplePackage": "N",
"IndicationAndUsage": "Prenatal and Postnatal prescriptive Folic Acid.",
"Description": "Each Tablet Contains. Amount per Tablet. Thiamine (Vitamin B-1) (from Thiamine Mononitrate) ................. 1.4 mg. Ascorbic Acid...................... ......................................................... 125 mg. Folic Acid ....................................................................................... 1 mg. Colecalciferol ............................................................................. .0125 mg. Pyridoxal Phosphate Anhydrous ................................................. 2.5 mg. Methylcobalamin.................. ........................................................ 1 mg. Calcium Carbonate ................................................................... 200 mg. Ferrous Gluconate ..................................................................... 13 mg. Potassium Iodide........................................................................ .15 mg. Other ingredients: magnesium stearate, microcrystalline cellulose, silicone dioxide."
},
{
"NDCCode": "85477-325-29",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (85477-325-29) ",
"NDC11Code": "85477-0325-29",
"ProductNDC": "85477-325",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidospra",
"NonProprietaryName": "Lidospra",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260825",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "41.2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260825",
"SamplePackage": "N",
"IndicationAndUsage": "LidoSpra is indicated for topical analgesia and for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, and rashes due to poison ivy, poison oak, or poison sumac, or as directed by a healthcare provider.",
"Description": "LidoSpra is a topical spray containing Lidocaine 4.12%."
},
{
"NDCCode": "85477-331-01",
"PackageDescription": "30 mL in 1 BOTTLE, WITH APPLICATOR (85477-331-01) ",
"NDC11Code": "85477-0331-01",
"ProductNDC": "85477-331",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tolfyra",
"NonProprietaryName": "Tolnaftate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "TOLNAFTATE",
"StrengthNumber": ".3",
"StrengthUnit": "g/30mL",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260501",
"SamplePackage": "N",
"IndicationAndUsage": "■ for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis). ■ relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions. ■ for the prevention of most Athlete’s foot with daily use. ■ eliminates fungus on fingers, toes, and around the nails. ■ eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush."
},
{
"NDCCode": "85477-503-30",
"PackageDescription": "1 TABLET in 1 BOTTLE (85477-503-30) ",
"NDC11Code": "85477-0503-30",
"ProductNDC": "85477-503",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metavex",
"NonProprietaryName": "Metavex",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "CHOLECALCIFEROL; FOLIC ACID; BLUE AGAVE INULIN (AGAVE TEQUILANA); ELM; ALOE FEROX LEAF; RHAMNUS CATHARTICA BARK",
"StrengthNumber": ".125; 1; 500; 425; 225; 135",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260101",
"SamplePackage": "N",
"IndicationAndUsage": "Metavex is indicated as a prescription dietary supplement for the dietary management of individuals with metabolic health needs where folic acid supplementation is appropriate. Administration: Take two (2) tablets daily with a 12-ounce glass of water, or as directed by a licensed healthcare practitioner.",
"Description": "Metavex is a prescription folic acid–containing dietary supplement intended to support metabolic health. Each tablet contains a combination of vitamins, minerals, and botanical ingredients formulated to provide nutritional support."
},
{
"NDCCode": "85477-511-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (85477-511-30) ",
"NDC11Code": "85477-0511-30",
"ProductNDC": "85477-511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folartex",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260223",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; MAGNESIUM OXIDE; FERROUS BISGLYCINATE; POTASSIUM IODIDE",
"StrengthNumber": "300; 60; 10; 4.5; 26; .28; 1.67; .013; 80; 25; 20; .15",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260223",
"SamplePackage": "N",
"IndicationAndUsage": "Folarex is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.",
"Description": "Folarex is a prescription multivitamin/multimineral dietary supplement. Other Ingredients: Microcrysta line Ce lulose, Maltodextrin, Croscarme lose Sodium, Silcon Dioxide, Stearic Acid, Magnesium Stearate, FiIm Coating (Hydroxypropyl Methylce lulose, Polyethylene Glycol, Titanium Dioxide, FD&C Blue# 1."
},
{
"NDCCode": "85477-513-30",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE (85477-513-30) ",
"NDC11Code": "85477-0513-30",
"ProductNDC": "85477-513",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitavera",
"NonProprietaryName": "Vitavera",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20260407",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; VITAMIN D; ALPHA-TOCOPHEROL ACETATE; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; LEVOMEFOLIC ACID; METHYLCOBALAMIN",
"StrengthNumber": "2500; 30; 30; 400; 15; 1; 1; 13; 1; 1000; 4",
"StrengthUnit": "[iU]/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260407",
"SamplePackage": "N",
"IndicationAndUsage": "Vitavera is indicated to provide supplemental amounts of essential vitamins including Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate. It is intended to supplement the diet and help prevent nutritional deficiencies. Formulated for use in patients requiring vitamin supplementation as directed by a licensed healthcare practitioner.",
"Description": "Vitavera is a chewable multivitamin dietary supplement containing essential vitamins including Vitamins A, C, D, E, B-complex vitamins, and folate. It is formulated to support general nutritional supplementation and overall health."
},
{
"NDCCode": "85477-523-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (85477-523-30) ",
"NDC11Code": "85477-0523-30",
"ProductNDC": "85477-523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folyra",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; MAGNESIUM OXIDE; FERROUS BISGLYCINATE; POTASSIUM IODIDE",
"StrengthNumber": "300; 60; 10; 4.5; 26; .28; 1.67; .013; 80; 25; 20; .15",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260101",
"SamplePackage": "N",
"IndicationAndUsage": "Folyra is a prescription multivitamin/multimineral dietary supplement indicated for the clinical dietary management of patients with suboptimal nutritional status requiring supplementation of folate and B vitamins, under physician supervision.",
"Description": "Folyra is a prescription multivitamin/multimineral dietary supplement."
},
{
"NDCCode": "85477-606-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (85477-606-30) ",
"NDC11Code": "85477-0606-30",
"ProductNDC": "85477-606",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Virexa",
"NonProprietaryName": "Vitamin C, Vitamin D3, Vitamin B1, Vitamin B6, Vitamin B12, Folic Acid, Nadh, Ubiquinone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250901",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE HCL; PYRIDOXAL PHOSPHATE ANHYDROUS; FOLIC ACID; METHYLCOBALAMIN; NICOTINAMIDE ADENINE DINUCLEOTIDE; UBIQUINONE",
"StrengthNumber": "125; 12.5; 25; 125; 1.667; 1; 5; 50",
"StrengthUnit": "mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Virexa is a multivitamin with folic acid dispensed by prescription only.",
"Description": "Active Ingredients: VItamin C, Vitamin D3, Vitamin B1, Vitamin B6, Vitamin B12, Folic Acid, NADH, Ubiquinone. Inactive Ingredients: Microcrystalline Cellulose, Pregeleatinized Starch, Coating (Beta-Carotene, Titanium Dioxide, Hypromellose, Polyvinyl Alcohol, Polyethylene Glycol, Talc), Croscarmellose Sodium, Silica, Silicon Dioxide, Hydroxypropyl Cellulose, Magnesium Stearate."
},
{
"NDCCode": "85477-610-30",
"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": "85477-901-30",
"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": "10135-823-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-30) ",
"NDC11Code": "10135-0823-30",
"ProductNDC": "10135-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202306",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260901",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Extended-Release Tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-Release Tablets USP, 500 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose and povidone. Metformin Hydrochloride Extended-Release Tablets USP, 750 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, red iron oxide and yellow iron oxide. System Components and Performance – Metformin Hydrochloride Extended-Release Tablets USP is based on a hydrophilic polymer matrix drug delivery system. On oral administration, fluid from the gastrointestinal tract wets and penetrates the matrix leading to the formation of a hydrogel and swelling of the polymer matrix. Drug is released slowly over time in a controlled manner, independent of pH, by a process of drug dissolution followed by drug diffusion through the hydrogel barrier formed and gradual matrix erosion. Metformin Hydrochloride Extended-Release Tablets USP meets USP Dissolution Test 6."
},
{
"NDCCode": "21695-823-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (21695-823-30)",
"NDC11Code": "21695-0823-30",
"ProductNDC": "21695-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20071226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076549",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ramipril capsules are indicated in patients 55 years or older at high risk of developing a major cardiovascular event because of a history of coronary artery disease, stroke, peripheral vascular disease, or diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria), to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes. Ramipril capsules can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy).",
"Description": "Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C and 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)-1[(S)-N-[(S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [b]pyrrole-2-carboxylic acid, 1-ethyl ester; its structural formula is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl angiotensin converting enzyme inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group. Ramipril is supplied as hard shell capsules for oral administration containing 1.25 mg, 2.5 mg, 5 mg, and 10 mg of ramipril. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains yellow iron oxide, the 2.5 mg capsule shell contains D&C yellow #10, D&C red #28, FD&C red #40 and yellow iron oxide, the 5 mg capsule shell contains D&C red #28, D&C yellow #10, FD&C blue #1 and FD&C red #40, and the 10 mg capsule shell contains D&C red #28, FD&C blue #1, FD&C red #40 and black iron oxide."
},
{
"NDCCode": "33261-823-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (33261-823-30)",
"NDC11Code": "33261-0823-30",
"ProductNDC": "33261-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077183",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "2.5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Amlodipine besylate and benazepril hydrochloride capsules is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting enzyme (ACE) inhibitor. Amlodipine besylate and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
"Description": "Amlodipine besylate and benazepril hydrochloride capsules is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)- propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its molecular formula is C24H28N205HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4- dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN205C6H603S, and its molecular weight is 567.1. Amlodipine besylate and benazepril hydrochloride capsules are formulated in six different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg,5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, hydrogenated castor oil, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and talc. Each hard-gelatin capsule contains gelatin, sodium lauryl sulfate, titanium dioxide, D&C yellow # 10 and D&C red # 28, (5 mg/20 mg, 10 mg/40 mg), FD&C blue # 1 and FD&C red # 40 (5 mg/20 mg, 5 mg/40 mg), FD & C Yellow 6 (5 mg/40 mg), FD&C green # 3 (2.5 mg/10 mg), iron oxide black (10 mg/20 mg) and iron oxide red (5 mg/20 mg and 10 mg/20 mg ) as coloring agents."
},
{
"NDCCode": "35356-823-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35356-823-30)",
"NDC11Code": "35356-0823-30",
"ProductNDC": "35356-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trifluoperazine Hydrochloride",
"NonProprietaryName": "Trifluoperazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040209",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "TRIFLUOPERAZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-11-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "42637-823-01",
"PackageDescription": "30 LOZENGE in 1 PACKAGE (42637-823-01) ",
"NDC11Code": "42637-0823-01",
"ProductNDC": "42637-823",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jakemans Peppermint",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Jakemans (Confectioners) Ltd.",
"SubstanceName": "MENTHOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N"
},
{
"NDCCode": "46708-823-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-823-30) ",
"NDC11Code": "46708-0823-30",
"ProductNDC": "46708-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexlansoprazole",
"NonProprietaryName": "Dexlansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219115",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DEXLANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251114",
"SamplePackage": "N",
"IndicationAndUsage": "Dexlansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: Healing of all grades of erosive esophagitis (EE). (1.1) Maintenance of healed EE and relief of heartburn. (1.2) Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). (1.3).",
"Description": "The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R-enantiomer of lansoprazole (a racemic mixture of the R-and S-enantiomers). Its empirical formula is: C16H14F3N3O2S, with a molecular weight of 369.36. Dexlansoprazole has the following chemical structure. Dexlansoprazole is a white to brownish powder which melts at about 146°C. Dexlansoprazole is freely soluble in methanol, dichloromethane, soluble in acetonitrile, practically insoluble in water. Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated pellets with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3)]. Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated pellets consisting of dexlansoprazole (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, confectioner’s sugar, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium carbonate, methacrylic acid copolymer dispersion, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol 8000, polysorbate 80, sodium lauryl sulfate, sugar spheres (composed of corn starch, sucrose, and water), talc, titanium dioxide and triethyl citrate. The capsule shell contains carrageenan, hypromellose and potassium chloride, Additionally, 30 mg capsule shell contains FD&C Blue No. 1, iron oxide red, iron oxide yellow, titanium dioxide and whereas 60 mg capsule shell contains iron oxide red. The capsule shells are printed with edible ink containing black iron oxide, potassium hydroxide and shellac."
}
]
}
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<NDCList>
<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>85477-322-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (85477-322-30) </PackageDescription>
<NDC11Code>85477-0322-30</NDC11Code>
<ProductNDC>85477-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Embriva</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Cholecalciferol, Thiamine, Pyridoxal Phosphate, Folic Acid, Methylcobalamin, Calcium Carbonate, Ferrous Gluconate, Potassium Iodide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250808</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>PYRIDOXAL PHOSPHATE ANHYDROUS; POTASSIUM IODIDE; ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE; FOLIC ACID; METHYLCOBALAMIN; CALCIUM CARBONATE; FERROUS GLUCONATE</SubstanceName>
<StrengthNumber>2.5; .15; 125; .0125; 1.4; 1; 1; 200; 13</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prenatal and Postnatal prescriptive Folic Acid.</IndicationAndUsage>
<Description>Each Tablet Contains. Amount per Tablet. Thiamine (Vitamin B-1) (from Thiamine Mononitrate) ................. 1.4 mg. Ascorbic Acid...................... ......................................................... 125 mg. Folic Acid ....................................................................................... 1 mg. Colecalciferol ............................................................................. .0125 mg. Pyridoxal Phosphate Anhydrous ................................................. 2.5 mg. Methylcobalamin.................. ........................................................ 1 mg. Calcium Carbonate ................................................................... 200 mg. Ferrous Gluconate ..................................................................... 13 mg. Potassium Iodide........................................................................ .15 mg. Other ingredients: magnesium stearate, microcrystalline cellulose, silicone dioxide.</Description>
</NDC>
<NDC>
<NDCCode>85477-325-29</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (85477-325-29) </PackageDescription>
<NDC11Code>85477-0325-29</NDC11Code>
<ProductNDC>85477-325</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidospra</ProprietaryName>
<NonProprietaryName>Lidospra</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260825</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>41.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LidoSpra is indicated for topical analgesia and for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, and rashes due to poison ivy, poison oak, or poison sumac, or as directed by a healthcare provider.</IndicationAndUsage>
<Description>LidoSpra is a topical spray containing Lidocaine 4.12%.</Description>
</NDC>
<NDC>
<NDCCode>85477-331-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, WITH APPLICATOR (85477-331-01) </PackageDescription>
<NDC11Code>85477-0331-01</NDC11Code>
<ProductNDC>85477-331</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tolfyra</ProprietaryName>
<NonProprietaryName>Tolnaftate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>TOLNAFTATE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>g/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis). ■ relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions. ■ for the prevention of most Athlete’s foot with daily use. ■ eliminates fungus on fingers, toes, and around the nails. ■ eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85477-503-30</NDCCode>
<PackageDescription>1 TABLET in 1 BOTTLE (85477-503-30) </PackageDescription>
<NDC11Code>85477-0503-30</NDC11Code>
<ProductNDC>85477-503</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metavex</ProprietaryName>
<NonProprietaryName>Metavex</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>CHOLECALCIFEROL; FOLIC ACID; BLUE AGAVE INULIN (AGAVE TEQUILANA); ELM; ALOE FEROX LEAF; RHAMNUS CATHARTICA BARK</SubstanceName>
<StrengthNumber>.125; 1; 500; 425; 225; 135</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metavex is indicated as a prescription dietary supplement for the dietary management of individuals with metabolic health needs where folic acid supplementation is appropriate. Administration: Take two (2) tablets daily with a 12-ounce glass of water, or as directed by a licensed healthcare practitioner.</IndicationAndUsage>
<Description>Metavex is a prescription folic acid–containing dietary supplement intended to support metabolic health. Each tablet contains a combination of vitamins, minerals, and botanical ingredients formulated to provide nutritional support.</Description>
</NDC>
<NDC>
<NDCCode>85477-511-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (85477-511-30) </PackageDescription>
<NDC11Code>85477-0511-30</NDC11Code>
<ProductNDC>85477-511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folartex</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260223</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; MAGNESIUM OXIDE; FERROUS BISGLYCINATE; POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>300; 60; 10; 4.5; 26; .28; 1.67; .013; 80; 25; 20; .15</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Folarex is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.</IndicationAndUsage>
<Description>Folarex is a prescription multivitamin/multimineral dietary supplement. Other Ingredients: Microcrysta line Ce lulose, Maltodextrin, Croscarme lose Sodium, Silcon Dioxide, Stearic Acid, Magnesium Stearate, FiIm Coating (Hydroxypropyl Methylce lulose, Polyethylene Glycol, Titanium Dioxide, FD&C Blue# 1.</Description>
</NDC>
<NDC>
<NDCCode>85477-513-30</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (85477-513-30) </PackageDescription>
<NDC11Code>85477-0513-30</NDC11Code>
<ProductNDC>85477-513</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitavera</ProprietaryName>
<NonProprietaryName>Vitavera</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260407</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; VITAMIN D; ALPHA-TOCOPHEROL ACETATE; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; LEVOMEFOLIC ACID; METHYLCOBALAMIN</SubstanceName>
<StrengthNumber>2500; 30; 30; 400; 15; 1; 1; 13; 1; 1000; 4</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitavera is indicated to provide supplemental amounts of essential vitamins including Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate. It is intended to supplement the diet and help prevent nutritional deficiencies. Formulated for use in patients requiring vitamin supplementation as directed by a licensed healthcare practitioner.</IndicationAndUsage>
<Description>Vitavera is a chewable multivitamin dietary supplement containing essential vitamins including Vitamins A, C, D, E, B-complex vitamins, and folate. It is formulated to support general nutritional supplementation and overall health.</Description>
</NDC>
<NDC>
<NDCCode>85477-523-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (85477-523-30) </PackageDescription>
<NDC11Code>85477-0523-30</NDC11Code>
<ProductNDC>85477-523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folyra</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; MAGNESIUM OXIDE; FERROUS BISGLYCINATE; POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>300; 60; 10; 4.5; 26; .28; 1.67; .013; 80; 25; 20; .15</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Folyra is a prescription multivitamin/multimineral dietary supplement indicated for the clinical dietary management of patients with suboptimal nutritional status requiring supplementation of folate and B vitamins, under physician supervision.</IndicationAndUsage>
<Description>Folyra is a prescription multivitamin/multimineral dietary supplement.</Description>
</NDC>
<NDC>
<NDCCode>85477-606-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (85477-606-30) </PackageDescription>
<NDC11Code>85477-0606-30</NDC11Code>
<ProductNDC>85477-606</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Virexa</ProprietaryName>
<NonProprietaryName>Vitamin C, Vitamin D3, Vitamin B1, Vitamin B6, Vitamin B12, Folic Acid, Nadh, Ubiquinone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oncora Pharma, LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE HCL; PYRIDOXAL PHOSPHATE ANHYDROUS; FOLIC ACID; METHYLCOBALAMIN; NICOTINAMIDE ADENINE DINUCLEOTIDE; UBIQUINONE</SubstanceName>
<StrengthNumber>125; 12.5; 25; 125; 1.667; 1; 5; 50</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Virexa is a multivitamin with folic acid dispensed by prescription only.</IndicationAndUsage>
<Description>Active Ingredients: VItamin C, Vitamin D3, Vitamin B1, Vitamin B6, Vitamin B12, Folic Acid, NADH, Ubiquinone. Inactive Ingredients: Microcrystalline Cellulose, Pregeleatinized Starch, Coating (Beta-Carotene, Titanium Dioxide, Hypromellose, Polyvinyl Alcohol, Polyethylene Glycol, Talc), Croscarmellose Sodium, Silica, Silicon Dioxide, Hydroxypropyl Cellulose, Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>85477-610-30</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>85477-901-30</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>10135-823-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-30) </PackageDescription>
<NDC11Code>10135-0823-30</NDC11Code>
<ProductNDC>10135-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202306</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin Hydrochloride Extended-Release Tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-Release Tablets USP, 500 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose and povidone. Metformin Hydrochloride Extended-Release Tablets USP, 750 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, red iron oxide and yellow iron oxide. System Components and Performance – Metformin Hydrochloride Extended-Release Tablets USP is based on a hydrophilic polymer matrix drug delivery system. On oral administration, fluid from the gastrointestinal tract wets and penetrates the matrix leading to the formation of a hydrogel and swelling of the polymer matrix. Drug is released slowly over time in a controlled manner, independent of pH, by a process of drug dissolution followed by drug diffusion through the hydrogel barrier formed and gradual matrix erosion. Metformin Hydrochloride Extended-Release Tablets USP meets USP Dissolution Test 6.</Description>
</NDC>
<NDC>
<NDCCode>21695-823-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (21695-823-30)</PackageDescription>
<NDC11Code>21695-0823-30</NDC11Code>
<ProductNDC>21695-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramipril</ProprietaryName>
<NonProprietaryName>Ramipril</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076549</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>RAMIPRIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ramipril capsules are indicated in patients 55 years or older at high risk of developing a major cardiovascular event because of a history of coronary artery disease, stroke, peripheral vascular disease, or diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria), to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes. Ramipril capsules can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy).</IndicationAndUsage>
<Description>Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C and 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)-1[(S)-N-[(S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [b]pyrrole-2-carboxylic acid, 1-ethyl ester; its structural formula is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl angiotensin converting enzyme inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group. Ramipril is supplied as hard shell capsules for oral administration containing 1.25 mg, 2.5 mg, 5 mg, and 10 mg of ramipril. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains yellow iron oxide, the 2.5 mg capsule shell contains D&C yellow #10, D&C red #28, FD&C red #40 and yellow iron oxide, the 5 mg capsule shell contains D&C red #28, D&C yellow #10, FD&C blue #1 and FD&C red #40, and the 10 mg capsule shell contains D&C red #28, FD&C blue #1, FD&C red #40 and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>33261-823-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (33261-823-30)</PackageDescription>
<NDC11Code>33261-0823-30</NDC11Code>
<ProductNDC>33261-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077183</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amlodipine besylate and benazepril hydrochloride capsules is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting enzyme (ACE) inhibitor. Amlodipine besylate and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).</IndicationAndUsage>
<Description>Amlodipine besylate and benazepril hydrochloride capsules is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)- propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its molecular formula is C24H28N205HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4- dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN205C6H603S, and its molecular weight is 567.1. Amlodipine besylate and benazepril hydrochloride capsules are formulated in six different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg,5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, hydrogenated castor oil, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and talc. Each hard-gelatin capsule contains gelatin, sodium lauryl sulfate, titanium dioxide, D&C yellow # 10 and D&C red # 28, (5 mg/20 mg, 10 mg/40 mg), FD&C blue # 1 and FD&C red # 40 (5 mg/20 mg, 5 mg/40 mg), FD & C Yellow 6 (5 mg/40 mg), FD&C green # 3 (2.5 mg/10 mg), iron oxide black (10 mg/20 mg) and iron oxide red (5 mg/20 mg and 10 mg/20 mg ) as coloring agents.</Description>
</NDC>
<NDC>
<NDCCode>35356-823-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35356-823-30)</PackageDescription>
<NDC11Code>35356-0823-30</NDC11Code>
<ProductNDC>35356-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trifluoperazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Trifluoperazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040209</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>TRIFLUOPERAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42637-823-01</NDCCode>
<PackageDescription>30 LOZENGE in 1 PACKAGE (42637-823-01) </PackageDescription>
<NDC11Code>42637-0823-01</NDC11Code>
<ProductNDC>42637-823</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Jakemans Peppermint</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Jakemans (Confectioners) Ltd.</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>46708-823-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-823-30) </PackageDescription>
<NDC11Code>46708-0823-30</NDC11Code>
<ProductNDC>46708-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexlansoprazole</ProprietaryName>
<NonProprietaryName>Dexlansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219115</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DEXLANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexlansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: Healing of all grades of erosive esophagitis (EE). (1.1) Maintenance of healed EE and relief of heartburn. (1.2) Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). (1.3).</IndicationAndUsage>
<Description>The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R-enantiomer of lansoprazole (a racemic mixture of the R-and S-enantiomers). Its empirical formula is: C16H14F3N3O2S, with a molecular weight of 369.36. Dexlansoprazole has the following chemical structure. Dexlansoprazole is a white to brownish powder which melts at about 146°C. Dexlansoprazole is freely soluble in methanol, dichloromethane, soluble in acetonitrile, practically insoluble in water. Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated pellets with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3)]. Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated pellets consisting of dexlansoprazole (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, confectioner’s sugar, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium carbonate, methacrylic acid copolymer dispersion, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol 8000, polysorbate 80, sodium lauryl sulfate, sugar spheres (composed of corn starch, sucrose, and water), talc, titanium dioxide and triethyl citrate. The capsule shell contains carrageenan, hypromellose and potassium chloride, Additionally, 30 mg capsule shell contains FD&C Blue No. 1, iron oxide red, iron oxide yellow, titanium dioxide and whereas 60 mg capsule shell contains iron oxide red. The capsule shells are printed with edible ink containing black iron oxide, potassium hydroxide and shellac.</Description>
</NDC>
</NDCList>