{
"NDC": [
{
"NDCCode": "75854-312-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-312-30) ",
"NDC11Code": "75854-0312-30",
"ProductNDC": "75854-312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenate Dha",
"NonProprietaryName": "Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Folic Acid, Levomefolate Calcium, Pyridoxine Hydrochloride, Cyanocobalamin, Calcium Formate, Ferrous Asparto Glycinate, Magnesium Oxide And Doconexent",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140605",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "LEVOMEFOLATE CALCIUM; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM FORMATE; FERROUS ASPARTO GLYCINATE; MAGNESIUM OXIDE; DOCONEXENT",
"StrengthNumber": "600; 90; 10; 18; 400; 26; 25; 160; 18; 50; 300",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; ug/1; mg/1; ug/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], Folate Analog [EPC], Folic Acid [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": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140605",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS: PRENATE DHA ® is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.",
"Description": "DESCRIPTION: PRENATE DHA® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is blue in color, opaque, and imprinted with “DHA” on one side and blank on the other. PRENATE DHA® can also be beneficial in improving the nutritional status of women prior to conception. PRENATE DHA ® contains fish oil and soy. OTHER INGREDIENTS: Gelatin capsule (FD&C Blue #1, FD&C Red #3, gelatin, glycerin, purified water, sorbitol and titanium dioxide), beeswax, soy lecithin, and soybean oil."
},
{
"NDCCode": "75854-104-30",
"PackageDescription": "30 BOX in 1 CARTON (75854-104-30) > 3.7 g in 1 BOX",
"NDC11Code": "75854-0104-30",
"ProductNDC": "75854-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosula",
"NonProprietaryName": "Sodium Sulfacetamide 10% And Sulfur 5%",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150313",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "100; 50",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150313",
"SamplePackage": "N"
},
{
"NDCCode": "75854-301-30",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (75854-301-30) ",
"NDC11Code": "75854-0301-30",
"ProductNDC": "75854-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenate Elite",
"NonProprietaryName": ".beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Pantothenate, Calcium Carbonate, Ferrous Fumarate, Potassium Iodide, Magnesium Oxide, Zinc Oxide And Cupric Oxide",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120806",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": ".BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE",
"StrengthNumber": "2600; 75; 450; 10; 3; 3.5; 21; 21; 1; 13; 330; 6; 100; 26; 150; 25; 15; 1.5",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20120806",
"SamplePackage": "N"
},
{
"NDCCode": "75854-302-30",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (75854-302-30) > 30 CAPSULE, GELATIN COATED in 1 BLISTER PACK",
"NDC11Code": "75854-0302-30",
"ProductNDC": "75854-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenate Dha",
"NonProprietaryName": "Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide And Doconexent",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120131",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; MAGNESIUM OXIDE; DOCONEXENT",
"StrengthNumber": "90; 220; 10; 26; 1; 13; 145; 28; 50; 300",
"StrengthUnit": "mg/1; [iU]/1; [iU]/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20120131",
"SamplePackage": "N"
},
{
"NDCCode": "75854-303-30",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (75854-303-30) > 30 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "75854-0303-30",
"ProductNDC": "75854-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenate Essential",
"NonProprietaryName": "- Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Carbonate, Ferrous Fumarate, Potassium Iodide, Magnesium Oxide, Doconexent And Icosapent",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121112",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT; ICOSAPENT",
"StrengthNumber": "90; 220; 10; 26; 1; 13; 280; 145; 29; 150; 50; 300; 40",
"StrengthUnit": "mg/1; [iU]/1; [iU]/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20121112",
"SamplePackage": "N"
},
{
"NDCCode": "75854-304-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-304-30) ",
"NDC11Code": "75854-0304-30",
"ProductNDC": "75854-304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenate Mini",
"NonProprietaryName": "Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Carbonate, Iron Pentacarbonyl, Potassium Iodide, Magnesium Oxide, Doconexent And Lowbush Blueberry",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120515",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM CARBONATE; IRON PENTACARBONYL; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT; LOWBUSH BLUEBERRY; ASCORBIC ACID",
"StrengthNumber": "220; 10; 26; 1; 13; 280; 100; 29; 150; 25; 350; 25; 60",
"StrengthUnit": "[iU]/1; [iU]/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20120515",
"SamplePackage": "N"
},
{
"NDCCode": "75854-305-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (75854-305-30) ",
"NDC11Code": "75854-0305-30",
"ProductNDC": "75854-305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Feriva",
"NonProprietaryName": "Ferrous Bisglycinate, Ascorbic Acid, Folic Acid, Cyanocobalamin, Biotin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20121230",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "FERROUS BISGLYCINATE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; BIOTIN",
"StrengthNumber": "75; 175; 1; 120; 300",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20121230",
"SamplePackage": "N"
},
{
"NDCCode": "75854-306-30",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE (75854-306-30) ",
"NDC11Code": "75854-0306-30",
"ProductNDC": "75854-306",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenate Chewable",
"NonProprietaryName": "Calcium Carbonate, Cholecalciferol, Magnesium Oxide, Boron, Folic Acid, Levomefolate Glucosamine, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin And Blueberry",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20130116",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "CALCIUM CARBONATE; CHOLECALCIFEROL; MAGNESIUM OXIDE; BORON; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; BLUEBERRY; LEVOMEFOLATE GLUCOSAMINE",
"StrengthNumber": "500; 7.5; 50; 12.5; 400; 10; 125; 280; 25; 600",
"StrengthUnit": "mg/1; ug/1; mg/1; ug/1; ug/1; mg/1; ug/1; ug/1; mg/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], 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 D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130116",
"SamplePackage": "N",
"IndicationAndUsage": "PRENATE CHEWABLE ®is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. PRENATE CHEWABLE ®can also be beneficial in improving the nutritional status of women prior to conception.",
"Description": "PRENATE CHEWABLE ®is a prescription prenatal/postnatal multivitamin/mineral chocolate chewable tablet. Each tablet is brown and imprinted with “Prenate Chew” on one side and blank on the other. OTHER INGREDIENTS:Cocoa powder, magnesium stearate, maltodextrin, modified food starch, natural milk chocolate flavor, silica, stearic acid, and sucrose. THIS PRODUCT MAY CONTAIN SOY."
},
{
"NDCCode": "75854-307-30",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (75854-307-30) ",
"NDC11Code": "75854-0307-30",
"ProductNDC": "75854-307",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenate Am",
"NonProprietaryName": ".pyridoxine Hydrochloride, Cyanocobalamin, Calcium Carbonate And Folic Acid",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130615",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM CARBONATE; FOLIC ACID",
"StrengthNumber": "75; 12; 200; 1",
"StrengthUnit": "mg/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130615",
"SamplePackage": "N",
"Description": "DESCRIPTION: PRENATE ® AM is a yellow, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with \"Prenate\" on one side and \"AM\" on the other."
},
{
"NDCCode": "75854-308-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-308-30) ",
"NDC11Code": "75854-0308-30",
"ProductNDC": "75854-308",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenate Restore",
"NonProprietaryName": "Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Lactic Acid And Doconexent",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130917",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM CARBONATE; FERROUS FUMARATE; MAGNESIUM OXIDE; LACTIC ACID; DOCONEXENT",
"StrengthNumber": "85; 1000; 10; 1; 25; 12; 500; 155; 27; 45; 10; 400",
"StrengthUnit": "mg/1; [iU]/1; [iU]/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Acidifying Activity [MoA], 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": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130917",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS: PRENATE ® Restore is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women during the postnatal period for both lactating and nonlactating mothers.",
"Description": "DESCRIPTION: PRENATE ® Restore is a prescription postnatal vitamin dietary supplement that contains probiotics, DHA and advanced calcium. Each dark blue softgel is imprinted with Omega Rx on one side and blank on the other."
},
{
"NDCCode": "75854-309-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-309-30) ",
"NDC11Code": "75854-0309-30",
"ProductNDC": "75854-309",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenate Enhance",
"NonProprietaryName": "Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Lactic Acid And Doconexent",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130917",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT",
"StrengthNumber": "85; 1000; 10; 1; 25; 12; 500; 155; 28; 150; 50; 400",
"StrengthUnit": "mg/1; [iU]/1; [iU]/1; mg/1; mg/1; ug/1; ug/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": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131016",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS: PRENATE ® Enhance is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. PRENATE ® Enhance can also be beneficial in improving the nutritional status of women prior to conception.",
"Description": "DESCRIPTION: PRENATE® Enhance is a prescription prenatal vitamin that contains 400 mg of DHA and advanced calcium. Each dark purple softgel is imprinted with “N” on one side and blank on the other. OTHER INGREDIENTS: Beeswax, palm shortening, and soy lecithin, Gelatin capsule (FD+C Blue #1, FD+C Red #40, gelatin, glycerin, purified water, sorbitol, and titanium dioxide)."
},
{
"NDCCode": "75854-310-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-310-30) ",
"NDC11Code": "75854-0310-30",
"ProductNDC": "75854-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ferivafa",
"NonProprietaryName": "Ferrous Bisglycinate, Ascorbic Acid, Folic Acid, Cyanocobalamin, Biotin, Cupric Oxide And Docusate Sodium",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140102",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "FERROUS BISGLYCINATE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CUPRIC OXIDE; DOCUSATE SODIUM",
"StrengthNumber": "110; 175; 1; 12; 300; 1; 50",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140102",
"SamplePackage": "N"
},
{
"NDCCode": "75854-311-30",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (75854-311-30) ",
"NDC11Code": "75854-0311-30",
"ProductNDC": "75854-311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenate Star",
"NonProprietaryName": ".beta.-carotene, Ascorbic Acid, Cholecalciferol, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Pantothenate, Calcium Formate, Ferrous Asparto Glycinate, Potassium Iodide, Magnesium Oxide, Zinc Oxide And Cupric Oxide",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140605",
"EndMarketingDate": "20180131",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": ".BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; CALCIUM FORMATE; FERROUS ASPARTO GLYCINATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE",
"StrengthNumber": "3300; 75; 450; 1.5; 2; 21; 21; 1; 12; 330; 6; 155; 20; 150; 25; 15; 1.5",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140605",
"EndMarketingDatePackage": "20180131",
"SamplePackage": "N"
},
{
"NDCCode": "75854-313-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-313-30) ",
"NDC11Code": "75854-0313-30",
"ProductNDC": "75854-313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenate Essential",
"NonProprietaryName": "Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Biotin, Calcium Formate, Ferrous Asparto Glycinate, Potassium Iodide, Magnesium Oxide, Doconexent And Icosapent",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140718",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "ICOSAPENT; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM; CYANOCOBALAMIN; BIOTIN; CALCIUM FORMATE; FERROUS ASPARTO GLYCINATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT",
"StrengthNumber": "40; 90; 5.5; 4.5; 26; 400; 600; 13; 280; 160; 18; 150; 50; 300",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; ug/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], Folate Analog [EPC], Folic Acid [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": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140718",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS: PRENATE ESSENTIAL ® is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.",
"Description": "DESCRIPTION: PRENATE ESSENTIAL® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is dark green in color, opaque, and imprinted with “Prenate” on one side and blank on the other. PRENATE ESSENTIAL® contains fish oil and soy."
},
{
"NDCCode": "75854-314-30",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (75854-314-30) ",
"NDC11Code": "75854-0314-30",
"ProductNDC": "75854-314",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenate Elite",
"NonProprietaryName": ".beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Calcium Formate, Ferrous Asparto Glycinate, Cyanocobalamin, Biotin, Potassium Iodide, Magnesium Oxide, Zinc Oxide And Cupric Oxide",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140605",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": ".BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM; CALCIUM FORMATE; FERROUS ASPARTO GLYCINATE; CYANOCOBALAMIN; BIOTIN; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE",
"StrengthNumber": "780; 75; 15; 18; 3; 3.5; 21; 21; 400; 600; 160; 20; 13; 330; 150; 25; 15; 1.5",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; ug/1; ug/1; ug/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], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [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": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140605",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS: PRENATE ELITE ® is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.",
"Description": "DESCRIPTION: PRENATE ELITE ® is a white, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with “PN” on one side and blank on the other. Contains no ingredient made from gluten-containing grain (wheat, barley, or rye)."
},
{
"NDCCode": "75854-315-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-315-30) ",
"NDC11Code": "75854-0315-30",
"ProductNDC": "75854-315",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenate Mini",
"NonProprietaryName": "Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Biotin, Calcium Carbonate, Ferrous Asparto Glycinate, Iron, Potassium Iodide, Magnesium Oxide, Doconexent And Lowbush Blueberry",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141118",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "BIOTIN; CALCIUM CARBONATE; FERROUS ASPARTO GLYCINATE; IRON; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT; LOWBUSH BLUEBERRY; LEVOMEFOLATE CALCIUM; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": "280; 80; 9; 9; 150; 25; 350; 25; 600; 60; 25; 4.5; 26; 400; 13",
"StrengthUnit": "ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Folate Analog [EPC], Folic Acid [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": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141118",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS: PRENATE MINI ® is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.",
"Description": "DESCRIPTION: PRENATE MINI® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each oval softgel is teal green in color and imprinted with “Mini”. Contains no ingredient made from a gluten containing grain (wheat, barley or rye). Contains fish oil and soy."
},
{
"NDCCode": "75854-316-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (75854-316-30) ",
"NDC11Code": "75854-0316-30",
"ProductNDC": "75854-316",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenate Pixie",
"NonProprietaryName": "Ascorbic Acid, Biotin, Cholecalciferol, Cyanocobalamin, Levomefolate Calcium, Folic Acid, Ferrous Asparto Glycinate, Potassium Iodide, Pyridoxine Hydrochloride, .alpha.-tocopherol Acetate, Dl-, Docosahexaenoic Acid, And Blueberry",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140815",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; FERROUS ASPARTO GLYCINATE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; BLUEBERRY; DOCOSAHEXAENOIC ACID; LEVOMEFOLATE CALCIUM",
"StrengthNumber": "30; 75; 12.5; 13; 400; 10; 150; 5; 4.5; 5; 200; 600",
"StrengthUnit": "mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], 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": "2025-05-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140815",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS:PRENATE PIXIE ®is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.",
"Description": "Rx Only Dietary Supplement. DESCRIPTION:PRENATE PIXIE ®is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color, opaque, and imprinted with “PIX”. Prenate Pixie ®contains no ingredient made from gluten-containing grain (wheat, barley, or rye)."
},
{
"NDCCode": "75854-319-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-319-30) ",
"NDC11Code": "75854-0319-30",
"ProductNDC": "75854-319",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Feriva Fa",
"NonProprietaryName": "Ferrous Bisglycinate, Ferrous Asparto Glycinate, Ferrous Fumarate, Ascorbic Acid, Folic Acid, Cyanocobalamin, Biotin, Cupric Oxide And Docusate Sodium",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "FERROUS BISGLYCINATE; FERROUS ASPARTO GLYCINATE; FERROUS FUMARATE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CUPRIC OXIDE; DOCUSATE SODIUM",
"StrengthNumber": "36.7; 36.7; 36.7; 175; 1; 12; 300; 1.5; 50",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B 12 [CS],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150101",
"SamplePackage": "N"
},
{
"NDCCode": "75854-320-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (75854-320-30) ",
"NDC11Code": "75854-0320-30",
"ProductNDC": "75854-320",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chromagen",
"NonProprietaryName": "Ferrous Asparto Glycinate, Ferrous Fumarate, Ascorbic Acid, Folic Acid, Levomefolate Glucosamine, Cyanocobalamin, Zinc, And Intrinsic Factor",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170110",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "FERROUS ASPARTO GLYCINATE; FERROUS FUMARATE; ASCORBIC ACID; LEVOMEFOLATE GLUCOSAMINE; FOLIC ACID; CYANOCOBALAMIN; ZINC; INTRINSIC FACTOR",
"StrengthNumber": "25; 50; 60; 750; 250; 10; 12; 100",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170123",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS: Chromagen is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.",
"Description": "DESCRIPTION: Chromagen for oral administration is an iron supplement softgel that is pearlescent dark blue and embossed with “CH75” on one side."
},
{
"NDCCode": "75854-321-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (75854-321-30) ",
"NDC11Code": "75854-0321-30",
"ProductNDC": "75854-321",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niferex",
"NonProprietaryName": "Ferrous Asparto Glycinate, Iron, Ascorbic Acid, Folic Acid, Cyanocobalamin, Zinc, Succinic Acid, And Intrinsic Factor",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170110",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "ASCORBIC ACID; CYANOCOBALAMIN; FERROUS ASPARTO GLYCINATE; FOLIC ACID; INTRINSIC FACTOR; IRON DEXTRAN; LEVOMEFOLIC ACID; SUCCINIC ACID; ZINC",
"StrengthNumber": "60; 25; 50; 250; 100; 100; 750; 50; 15",
"StrengthUnit": "mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170110",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS: Niferex is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.",
"Description": "DESCRIPTION: Niferex for oral administrationis a prenatal/postnatal iron supplement that is a round, copper colored tablet with \"NxFE\" embossed on one side."
},
{
"NDCCode": "75854-322-30",
"PackageDescription": "30 PILL in 1 BOTTLE (75854-322-30) ",
"NDC11Code": "75854-0322-30",
"ProductNDC": "75854-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Primacare",
"NonProprietaryName": "Calcium Ascorbate Dihydrate, Cholecalciferol, Dl-a Tocopheryl Acetate, Riboflavin, Niacinamide, Folate, Biotin, Calcium, Ferrous Asparto Glycinate, Potassium Iodide, Magnesium Oxide, Zinc Bisglycinate Chelate, Alpha Linoleic Acid, Dha, Epa",
"DosageFormName": "PILL",
"RouteName": "ORAL",
"StartMarketingDate": "20170123",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals",
"SubstanceName": "ALPHA-TOCOPHEROL ACETATE; BIOTIN; CALCIUM ASCORBATE; CALCIUM CARBONATE; CHOLECALCIFEROL; FOLIC ACID; LINOLEIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; OMEGA-3 FATTY ACIDS; POTASSIUM IODIDE; PYRIDOXINE; RIBOFLAVIN; ZINC",
"StrengthNumber": "15; 1; 25; 100; 1000; 1; 50; 50; 10; 420; 150; 50; 1.5; 15",
"StrengthUnit": "[iU]/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/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], Fatty Acids, Omega-3 [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], Omega-3 Fatty Acid [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170123",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS: PrimaCare is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of omen throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.",
"Description": "DESCRIPTION: PrimaCare is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color and imprinted with “PRIMA” on one side and blank on the other.'. PrimaCare contains flaxseed oil, fish oil and soy. OTHER INGREDIENTS: Gelatin capsule (bovine gelatin, sorbitol, glycerin, purified water, titanium dioxide, FD&C Red #40, caramel coloring, FD&C Blue #1), yellow beeswax and soy lecithin."
},
{
"NDCCode": "75854-344-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (75854-344-30) ",
"NDC11Code": "75854-0344-30",
"ProductNDC": "75854-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niferex",
"NonProprietaryName": "Ferrous Asparto Glycinate, Iron, Ascorbic Acid, Folic Acid, Cyanocobalamin, Zinc, And Succinic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241216",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "FERROUS ASPARTO GLYCINATE; ASCORBIC ACID; LEVOMEFOLATE GLUCOSAMINE; FOLIC ACID; CYANOCOBALAMIN; ZINC; SUCCINIC ACID",
"StrengthNumber": "75; 175; 750; 250; 25; 15; 150",
"StrengthUnit": "mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241216",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS: Niferex® is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.",
"Description": "DESCRIPTION: Niferex® for oral administration is an iron supplement that is an oval, copper colored, coated tablet with \"344\" embossed on one side."
},
{
"NDCCode": "75854-602-02",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (75854-602-02) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "75854-0602-02",
"ProductNDC": "75854-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Balcoltra",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180410",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208612",
"LabelerName": "Avion Pharmaceuticals",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180410",
"SamplePackage": "N",
"IndicationAndUsage": "Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Balcoltra (levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets) provides an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets. 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound. 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate. The inactive ingredients present in orange active tablet are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch. Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate, citric acid, glycine, water, maltodextrin , silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake. Levonorgestrel has the empirical formula of C21H28O2 and the molecular weight of 312.4, and ethinyl estradiol has the empirical formula of C20H24O2 and the molecular weight of 296.4. The molecular structures are provided below."
},
{
"NDCCode": "75854-602-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (75854-602-03) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "75854-0602-03",
"ProductNDC": "75854-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Balcoltra",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180410",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208612",
"LabelerName": "Avion Pharmaceuticals",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180410",
"SamplePackage": "N",
"IndicationAndUsage": "Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Balcoltra (levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets) provides an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets. 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound. 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate. The inactive ingredients present in orange active tablet are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch. Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate, citric acid, glycine, water, maltodextrin , silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake. Levonorgestrel has the empirical formula of C21H28O2 and the molecular weight of 312.4, and ethinyl estradiol has the empirical formula of C20H24O2 and the molecular weight of 296.4. The molecular structures are provided below."
},
{
"NDCCode": "75854-602-28",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (75854-602-28) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "75854-0602-28",
"ProductNDC": "75854-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Balcoltra",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180410",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208612",
"LabelerName": "Avion Pharmaceuticals",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180410",
"SamplePackage": "N",
"IndicationAndUsage": "Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Balcoltra (levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets) provides an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets. 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound. 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate. The inactive ingredients present in orange active tablet are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch. Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate, citric acid, glycine, water, maltodextrin , silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake. Levonorgestrel has the empirical formula of C21H28O2 and the molecular weight of 312.4, and ethinyl estradiol has the empirical formula of C20H24O2 and the molecular weight of 296.4. The molecular structures are provided below."
},
{
"NDCCode": "13537-312-02",
"PackageDescription": "1 BOTTLE in 1 BOX (13537-312-02) > 30 mL in 1 BOTTLE (13537-312-01)",
"NDC11Code": "13537-0312-02",
"ProductNDC": "13537-312",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika",
"ProprietaryNameSuffix": "Hydro-nutrative Foundation Spf 13",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110517",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation (San Juan, P.R)",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".05; .02",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides moderate protection against sunburn."
},
{
"NDCCode": "13668-312-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (13668-312-30) ",
"NDC11Code": "13668-0312-30",
"ProductNDC": "13668-312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Olmesartan Medoxomil",
"NonProprietaryName": "Amlodipine And Olmesartan Medoxomil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202933",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "AMLODIPINE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "10; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20161125",
"SamplePackage": "N"
},
{
"NDCCode": "16590-312-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16590-312-30)",
"NDC11Code": "16590-0312-30",
"ProductNDC": "16590-312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diovan Hct",
"NonProprietaryName": "Hydrochlorothiazide, Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060428",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020818",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "HYDROCHLOROTHIAZIDE; VALSARTAN",
"StrengthNumber": "12.5; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.",
"Description": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is."
},
{
"NDCCode": "16714-312-02",
"PackageDescription": "30 TABLET in 1 BOTTLE (16714-312-02)",
"NDC11Code": "16714-0312-02",
"ProductNDC": "16714-312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078932",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-07-29",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "33342-312-07",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-312-07) ",
"NDC11Code": "33342-0312-07",
"ProductNDC": "33342-312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine And Donepezil",
"NonProprietaryName": "Memantine And Donepezil",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208672",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "14; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250715",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.",
"Description": "Memantine and donepezil hydrochlorides extended-release capsules contain memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine HydrochlorideThe chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac."
}
]
}
{"NDC":[{"NDCCode":"75854-312-30","ProprietaryName":"Prenate Dha","NonProprietaryName":"Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Folic Acid, Levomefolate Calcium, Pyridoxine Hydrochloride, Cyanocobalamin, Calcium Formate, Ferrous Asparto Glycinate, Magnesium Oxide And Doconexent"},{"NDCCode":"75854-104-30","ProprietaryName":"Rosula","NonProprietaryName":"Sodium Sulfacetamide 10% And Sulfur 5%"},{"NDCCode":"75854-301-30","ProprietaryName":"Prenate Elite","NonProprietaryName":".beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Pantothenate, Calcium Carbonate, Ferrous Fumarate, Potassium Iodide, Magnesium Oxide, Zinc Oxide And Cupric Oxide"},{"NDCCode":"75854-302-30","ProprietaryName":"Prenate Dha","NonProprietaryName":"Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide And Doconexent"},{"NDCCode":"75854-303-30","ProprietaryName":"Prenate Essential","NonProprietaryName":"- Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Carbonate, Ferrous Fumarate, Potassium Iodide, Magnesium Oxide, Doconexent And Icosapent"},{"NDCCode":"75854-304-30","ProprietaryName":"Prenate Mini","NonProprietaryName":"Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Carbonate, Iron Pentacarbonyl, Potassium Iodide, Magnesium Oxide, Doconexent And Lowbush Blueberry"},{"NDCCode":"75854-305-30","ProprietaryName":"Feriva","NonProprietaryName":"Ferrous Bisglycinate, Ascorbic Acid, Folic Acid, Cyanocobalamin, Biotin"},{"NDCCode":"75854-306-30","ProprietaryName":"Prenate Chewable","NonProprietaryName":"Calcium Carbonate, Cholecalciferol, Magnesium Oxide, Boron, Folic Acid, Levomefolate Glucosamine, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin And Blueberry"},{"NDCCode":"75854-307-30","ProprietaryName":"Prenate Am","NonProprietaryName":".pyridoxine Hydrochloride, Cyanocobalamin, Calcium Carbonate And Folic Acid"},{"NDCCode":"75854-308-30","ProprietaryName":"Prenate Restore","NonProprietaryName":"Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Lactic Acid And Doconexent"},{"NDCCode":"75854-309-30","ProprietaryName":"Prenate Enhance","NonProprietaryName":"Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Lactic Acid And Doconexent"},{"NDCCode":"75854-310-30","ProprietaryName":"Ferivafa","NonProprietaryName":"Ferrous Bisglycinate, Ascorbic Acid, Folic Acid, Cyanocobalamin, Biotin, Cupric Oxide And Docusate Sodium"},{"NDCCode":"75854-311-30","ProprietaryName":"Prenate Star","NonProprietaryName":".beta.-carotene, Ascorbic Acid, Cholecalciferol, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Pantothenate, Calcium Formate, Ferrous Asparto Glycinate, Potassium Iodide, Magnesium Oxide, Zinc Oxide And Cupric Oxide"},{"NDCCode":"75854-313-30","ProprietaryName":"Prenate Essential","NonProprietaryName":"Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Biotin, Calcium Formate, Ferrous Asparto Glycinate, Potassium Iodide, Magnesium Oxide, Doconexent And Icosapent"},{"NDCCode":"75854-314-30","ProprietaryName":"Prenate Elite","NonProprietaryName":".beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Levomefolate 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<SubstanceName>LEVOMEFOLATE CALCIUM; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM FORMATE; FERROUS ASPARTO GLYCINATE; MAGNESIUM OXIDE; DOCONEXENT</SubstanceName>
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<PackageDescription>30 BOX in 1 CARTON (75854-104-30) > 3.7 g in 1 BOX</PackageDescription>
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<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<PackageDescription>30 TABLET, COATED in 1 BOTTLE (75854-301-30) </PackageDescription>
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<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
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<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
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<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
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<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<PackageDescription>30 BLISTER PACK in 1 CARTON (75854-303-30) > 30 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>75854-0303-30</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenate Essential</ProprietaryName>
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<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121112</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT; ICOSAPENT</SubstanceName>
<StrengthNumber>90; 220; 10; 26; 1; 13; 280; 145; 29; 150; 50; 300; 40</StrengthNumber>
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<Pharm_Classes>Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>75854-304-30</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-304-30) </PackageDescription>
<NDC11Code>75854-0304-30</NDC11Code>
<ProductNDC>75854-304</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenate Mini</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Carbonate, Iron Pentacarbonyl, Potassium Iodide, Magnesium Oxide, Doconexent And Lowbush Blueberry</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20120515</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM CARBONATE; IRON PENTACARBONYL; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT; LOWBUSH BLUEBERRY; ASCORBIC ACID</SubstanceName>
<StrengthNumber>220; 10; 26; 1; 13; 280; 100; 29; 150; 25; 350; 25; 60</StrengthNumber>
<StrengthUnit>[iU]/1; [iU]/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>75854-305-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (75854-305-30) </PackageDescription>
<NDC11Code>75854-0305-30</NDC11Code>
<ProductNDC>75854-305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Feriva</ProprietaryName>
<NonProprietaryName>Ferrous Bisglycinate, Ascorbic Acid, Folic Acid, Cyanocobalamin, Biotin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
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<StartMarketingDate>20121230</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>FERROUS BISGLYCINATE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; BIOTIN</SubstanceName>
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<Pharm_Classes>Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75854-306-30</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (75854-306-30) </PackageDescription>
<NDC11Code>75854-0306-30</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenate Chewable</ProprietaryName>
<NonProprietaryName>Calcium Carbonate, Cholecalciferol, Magnesium Oxide, Boron, Folic Acid, Levomefolate Glucosamine, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin And Blueberry</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130116</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CALCIUM CARBONATE; CHOLECALCIFEROL; MAGNESIUM OXIDE; BORON; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; BLUEBERRY; LEVOMEFOLATE GLUCOSAMINE</SubstanceName>
<StrengthNumber>500; 7.5; 50; 12.5; 400; 10; 125; 280; 25; 600</StrengthNumber>
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<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], 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 D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRENATE CHEWABLE ®is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. PRENATE CHEWABLE ®can also be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>PRENATE CHEWABLE ®is a prescription prenatal/postnatal multivitamin/mineral chocolate chewable tablet. Each tablet is brown and imprinted with “Prenate Chew” on one side and blank on the other. OTHER INGREDIENTS:Cocoa powder, magnesium stearate, maltodextrin, modified food starch, natural milk chocolate flavor, silica, stearic acid, and sucrose. THIS PRODUCT MAY CONTAIN SOY.</Description>
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<NDC>
<NDCCode>75854-307-30</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (75854-307-30) </PackageDescription>
<NDC11Code>75854-0307-30</NDC11Code>
<ProductNDC>75854-307</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenate Am</ProprietaryName>
<NonProprietaryName>.pyridoxine Hydrochloride, Cyanocobalamin, Calcium Carbonate And Folic Acid</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130615</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM CARBONATE; FOLIC ACID</SubstanceName>
<StrengthNumber>75; 12; 200; 1</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>DESCRIPTION: PRENATE ® AM is a yellow, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with "Prenate" on one side and "AM" on the other.</Description>
</NDC>
<NDC>
<NDCCode>75854-308-30</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-308-30) </PackageDescription>
<NDC11Code>75854-0308-30</NDC11Code>
<ProductNDC>75854-308</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenate Restore</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Lactic Acid And Doconexent</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130917</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM CARBONATE; FERROUS FUMARATE; MAGNESIUM OXIDE; LACTIC ACID; DOCONEXENT</SubstanceName>
<StrengthNumber>85; 1000; 10; 1; 25; 12; 500; 155; 27; 45; 10; 400</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; [iU]/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], 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>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS: PRENATE ® Restore is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women during the postnatal period for both lactating and nonlactating mothers.</IndicationAndUsage>
<Description>DESCRIPTION: PRENATE ® Restore is a prescription postnatal vitamin dietary supplement that contains probiotics, DHA and advanced calcium. Each dark blue softgel is imprinted with Omega Rx on one side and blank on the other.</Description>
</NDC>
<NDC>
<NDCCode>75854-309-30</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-309-30) </PackageDescription>
<NDC11Code>75854-0309-30</NDC11Code>
<ProductNDC>75854-309</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenate Enhance</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Lactic Acid And Doconexent</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130917</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT</SubstanceName>
<StrengthNumber>85; 1000; 10; 1; 25; 12; 500; 155; 28; 150; 50; 400</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; [iU]/1; mg/1; mg/1; ug/1; ug/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>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS: PRENATE ® Enhance is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. PRENATE ® Enhance can also be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>DESCRIPTION: PRENATE® Enhance is a prescription prenatal vitamin that contains 400 mg of DHA and advanced calcium. Each dark purple softgel is imprinted with “N” on one side and blank on the other. OTHER INGREDIENTS: Beeswax, palm shortening, and soy lecithin, Gelatin capsule (FD+C Blue #1, FD+C Red #40, gelatin, glycerin, purified water, sorbitol, and titanium dioxide).</Description>
</NDC>
<NDC>
<NDCCode>75854-310-30</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-310-30) </PackageDescription>
<NDC11Code>75854-0310-30</NDC11Code>
<ProductNDC>75854-310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ferivafa</ProprietaryName>
<NonProprietaryName>Ferrous Bisglycinate, Ascorbic Acid, Folic Acid, Cyanocobalamin, Biotin, Cupric Oxide And Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140102</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>FERROUS BISGLYCINATE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CUPRIC OXIDE; DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>110; 175; 1; 12; 300; 1; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75854-311-30</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (75854-311-30) </PackageDescription>
<NDC11Code>75854-0311-30</NDC11Code>
<ProductNDC>75854-311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenate Star</ProprietaryName>
<NonProprietaryName>.beta.-carotene, Ascorbic Acid, Cholecalciferol, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Pantothenate, Calcium Formate, Ferrous Asparto Glycinate, Potassium Iodide, Magnesium Oxide, Zinc Oxide And Cupric Oxide</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140605</StartMarketingDate>
<EndMarketingDate>20180131</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>.BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; CALCIUM FORMATE; FERROUS ASPARTO GLYCINATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE</SubstanceName>
<StrengthNumber>3300; 75; 450; 1.5; 2; 21; 21; 1; 12; 330; 6; 155; 20; 150; 25; 15; 1.5</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140605</StartMarketingDatePackage>
<EndMarketingDatePackage>20180131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75854-313-30</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-313-30) </PackageDescription>
<NDC11Code>75854-0313-30</NDC11Code>
<ProductNDC>75854-313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenate Essential</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Biotin, Calcium Formate, Ferrous Asparto Glycinate, Potassium Iodide, Magnesium Oxide, Doconexent And Icosapent</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140718</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ICOSAPENT; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM; CYANOCOBALAMIN; BIOTIN; CALCIUM FORMATE; FERROUS ASPARTO GLYCINATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT</SubstanceName>
<StrengthNumber>40; 90; 5.5; 4.5; 26; 400; 600; 13; 280; 160; 18; 150; 50; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; ug/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], Folate Analog [EPC], Folic Acid [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>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS: PRENATE ESSENTIAL ® is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.</IndicationAndUsage>
<Description>DESCRIPTION: PRENATE ESSENTIAL® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is dark green in color, opaque, and imprinted with “Prenate” on one side and blank on the other. PRENATE ESSENTIAL® contains fish oil and soy.</Description>
</NDC>
<NDC>
<NDCCode>75854-314-30</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (75854-314-30) </PackageDescription>
<NDC11Code>75854-0314-30</NDC11Code>
<ProductNDC>75854-314</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenate Elite</ProprietaryName>
<NonProprietaryName>.beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Calcium Formate, Ferrous Asparto Glycinate, Cyanocobalamin, Biotin, Potassium Iodide, Magnesium Oxide, Zinc Oxide And Cupric Oxide</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140605</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>.BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM; CALCIUM FORMATE; FERROUS ASPARTO GLYCINATE; CYANOCOBALAMIN; BIOTIN; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE</SubstanceName>
<StrengthNumber>780; 75; 15; 18; 3; 3.5; 21; 21; 400; 600; 160; 20; 13; 330; 150; 25; 15; 1.5</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; ug/1; ug/1; ug/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], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [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>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS: PRENATE ELITE ® is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.</IndicationAndUsage>
<Description>DESCRIPTION: PRENATE ELITE ® is a white, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with “PN” on one side and blank on the other. Contains no ingredient made from gluten-containing grain (wheat, barley, or rye).</Description>
</NDC>
<NDC>
<NDCCode>75854-315-30</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-315-30) </PackageDescription>
<NDC11Code>75854-0315-30</NDC11Code>
<ProductNDC>75854-315</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenate Mini</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Biotin, Calcium Carbonate, Ferrous Asparto Glycinate, Iron, Potassium Iodide, Magnesium Oxide, Doconexent And Lowbush Blueberry</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141118</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BIOTIN; CALCIUM CARBONATE; FERROUS ASPARTO GLYCINATE; IRON; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT; LOWBUSH BLUEBERRY; LEVOMEFOLATE CALCIUM; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>280; 80; 9; 9; 150; 25; 350; 25; 600; 60; 25; 4.5; 26; 400; 13</StrengthNumber>
<StrengthUnit>ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Folate Analog [EPC], Folic Acid [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>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS: PRENATE MINI ® is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.</IndicationAndUsage>
<Description>DESCRIPTION: PRENATE MINI® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each oval softgel is teal green in color and imprinted with “Mini”. Contains no ingredient made from a gluten containing grain (wheat, barley or rye). Contains fish oil and soy.</Description>
</NDC>
<NDC>
<NDCCode>75854-316-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (75854-316-30) </PackageDescription>
<NDC11Code>75854-0316-30</NDC11Code>
<ProductNDC>75854-316</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenate Pixie</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Biotin, Cholecalciferol, Cyanocobalamin, Levomefolate Calcium, Folic Acid, Ferrous Asparto Glycinate, Potassium Iodide, Pyridoxine Hydrochloride, .alpha.-tocopherol Acetate, Dl-, Docosahexaenoic Acid, And Blueberry</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; FERROUS ASPARTO GLYCINATE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; BLUEBERRY; DOCOSAHEXAENOIC ACID; LEVOMEFOLATE CALCIUM</SubstanceName>
<StrengthNumber>30; 75; 12.5; 13; 400; 10; 150; 5; 4.5; 5; 200; 600</StrengthNumber>
<StrengthUnit>mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], 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>2025-05-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS:PRENATE PIXIE ®is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.</IndicationAndUsage>
<Description>Rx Only Dietary Supplement. DESCRIPTION:PRENATE PIXIE ®is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color, opaque, and imprinted with “PIX”. Prenate Pixie ®contains no ingredient made from gluten-containing grain (wheat, barley, or rye).</Description>
</NDC>
<NDC>
<NDCCode>75854-319-30</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-319-30) </PackageDescription>
<NDC11Code>75854-0319-30</NDC11Code>
<ProductNDC>75854-319</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Feriva Fa</ProprietaryName>
<NonProprietaryName>Ferrous Bisglycinate, Ferrous Asparto Glycinate, Ferrous Fumarate, Ascorbic Acid, Folic Acid, Cyanocobalamin, Biotin, Cupric Oxide And Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>FERROUS BISGLYCINATE; FERROUS ASPARTO GLYCINATE; FERROUS FUMARATE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CUPRIC OXIDE; DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>36.7; 36.7; 36.7; 175; 1; 12; 300; 1.5; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B 12 [CS],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75854-320-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (75854-320-30) </PackageDescription>
<NDC11Code>75854-0320-30</NDC11Code>
<ProductNDC>75854-320</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chromagen</ProprietaryName>
<NonProprietaryName>Ferrous Asparto Glycinate, Ferrous Fumarate, Ascorbic Acid, Folic Acid, Levomefolate Glucosamine, Cyanocobalamin, Zinc, And Intrinsic Factor</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>FERROUS ASPARTO GLYCINATE; FERROUS FUMARATE; ASCORBIC ACID; LEVOMEFOLATE GLUCOSAMINE; FOLIC ACID; CYANOCOBALAMIN; ZINC; INTRINSIC FACTOR</SubstanceName>
<StrengthNumber>25; 50; 60; 750; 250; 10; 12; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS: Chromagen is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.</IndicationAndUsage>
<Description>DESCRIPTION: Chromagen for oral administration is an iron supplement softgel that is pearlescent dark blue and embossed with “CH75” on one side.</Description>
</NDC>
<NDC>
<NDCCode>75854-321-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (75854-321-30) </PackageDescription>
<NDC11Code>75854-0321-30</NDC11Code>
<ProductNDC>75854-321</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niferex</ProprietaryName>
<NonProprietaryName>Ferrous Asparto Glycinate, Iron, Ascorbic Acid, Folic Acid, Cyanocobalamin, Zinc, Succinic Acid, And Intrinsic Factor</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; CYANOCOBALAMIN; FERROUS ASPARTO GLYCINATE; FOLIC ACID; INTRINSIC FACTOR; IRON DEXTRAN; LEVOMEFOLIC ACID; SUCCINIC ACID; ZINC</SubstanceName>
<StrengthNumber>60; 25; 50; 250; 100; 100; 750; 50; 15</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS: Niferex is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.</IndicationAndUsage>
<Description>DESCRIPTION: Niferex for oral administrationis a prenatal/postnatal iron supplement that is a round, copper colored tablet with "NxFE" embossed on one side.</Description>
</NDC>
<NDC>
<NDCCode>75854-322-30</NDCCode>
<PackageDescription>30 PILL in 1 BOTTLE (75854-322-30) </PackageDescription>
<NDC11Code>75854-0322-30</NDC11Code>
<ProductNDC>75854-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Primacare</ProprietaryName>
<NonProprietaryName>Calcium Ascorbate Dihydrate, Cholecalciferol, Dl-a Tocopheryl Acetate, Riboflavin, Niacinamide, Folate, Biotin, Calcium, Ferrous Asparto Glycinate, Potassium Iodide, Magnesium Oxide, Zinc Bisglycinate Chelate, Alpha Linoleic Acid, Dha, Epa</NonProprietaryName>
<DosageFormName>PILL</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170123</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals</LabelerName>
<SubstanceName>ALPHA-TOCOPHEROL ACETATE; BIOTIN; CALCIUM ASCORBATE; CALCIUM CARBONATE; CHOLECALCIFEROL; FOLIC ACID; LINOLEIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; OMEGA-3 FATTY ACIDS; POTASSIUM IODIDE; PYRIDOXINE; RIBOFLAVIN; ZINC</SubstanceName>
<StrengthNumber>15; 1; 25; 100; 1000; 1; 50; 50; 10; 420; 150; 50; 1.5; 15</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/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], Fatty Acids, Omega-3 [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], Omega-3 Fatty Acid [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170123</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS: PrimaCare is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of omen throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.</IndicationAndUsage>
<Description>DESCRIPTION: PrimaCare is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color and imprinted with “PRIMA” on one side and blank on the other.'. PrimaCare contains flaxseed oil, fish oil and soy. OTHER INGREDIENTS: Gelatin capsule (bovine gelatin, sorbitol, glycerin, purified water, titanium dioxide, FD&C Red #40, caramel coloring, FD&C Blue #1), yellow beeswax and soy lecithin.</Description>
</NDC>
<NDC>
<NDCCode>75854-344-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (75854-344-30) </PackageDescription>
<NDC11Code>75854-0344-30</NDC11Code>
<ProductNDC>75854-344</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niferex</ProprietaryName>
<NonProprietaryName>Ferrous Asparto Glycinate, Iron, Ascorbic Acid, Folic Acid, Cyanocobalamin, Zinc, And Succinic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241216</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>FERROUS ASPARTO GLYCINATE; ASCORBIC ACID; LEVOMEFOLATE GLUCOSAMINE; FOLIC ACID; CYANOCOBALAMIN; ZINC; SUCCINIC ACID</SubstanceName>
<StrengthNumber>75; 175; 750; 250; 25; 15; 150</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS: Niferex® is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.</IndicationAndUsage>
<Description>DESCRIPTION: Niferex® for oral administration is an iron supplement that is an oval, copper colored, coated tablet with "344" embossed on one side.</Description>
</NDC>
<NDC>
<NDCCode>75854-602-02</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (75854-602-02) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>75854-0602-02</NDC11Code>
<ProductNDC>75854-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Balcoltra</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180410</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208612</ApplicationNumber>
<LabelerName>Avion Pharmaceuticals</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Balcoltra (levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets) provides an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets. 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound. 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate. The inactive ingredients present in orange active tablet are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch. Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate, citric acid, glycine, water, maltodextrin , silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake. Levonorgestrel has the empirical formula of C21H28O2 and the molecular weight of 312.4, and ethinyl estradiol has the empirical formula of C20H24O2 and the molecular weight of 296.4. The molecular structures are provided below.</Description>
</NDC>
<NDC>
<NDCCode>75854-602-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (75854-602-03) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>75854-0602-03</NDC11Code>
<ProductNDC>75854-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Balcoltra</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180410</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208612</ApplicationNumber>
<LabelerName>Avion Pharmaceuticals</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Balcoltra (levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets) provides an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets. 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound. 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate. The inactive ingredients present in orange active tablet are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch. Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate, citric acid, glycine, water, maltodextrin , silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake. Levonorgestrel has the empirical formula of C21H28O2 and the molecular weight of 312.4, and ethinyl estradiol has the empirical formula of C20H24O2 and the molecular weight of 296.4. The molecular structures are provided below.</Description>
</NDC>
<NDC>
<NDCCode>75854-602-28</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (75854-602-28) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>75854-0602-28</NDC11Code>
<ProductNDC>75854-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Balcoltra</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180410</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208612</ApplicationNumber>
<LabelerName>Avion Pharmaceuticals</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Balcoltra (levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets) provides an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets. 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound. 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate. The inactive ingredients present in orange active tablet are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch. Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate, citric acid, glycine, water, maltodextrin , silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake. Levonorgestrel has the empirical formula of C21H28O2 and the molecular weight of 312.4, and ethinyl estradiol has the empirical formula of C20H24O2 and the molecular weight of 296.4. The molecular structures are provided below.</Description>
</NDC>
<NDC>
<NDCCode>13537-312-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (13537-312-02) > 30 mL in 1 BOTTLE (13537-312-01)</PackageDescription>
<NDC11Code>13537-0312-02</NDC11Code>
<ProductNDC>13537-312</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika</ProprietaryName>
<ProprietaryNameSuffix>Hydro-nutrative Foundation Spf 13</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110517</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation (San Juan, P.R)</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.05; .02</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides moderate protection against sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13668-312-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (13668-312-30) </PackageDescription>
<NDC11Code>13668-0312-30</NDC11Code>
<ProductNDC>13668-312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Amlodipine And Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202933</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>AMLODIPINE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>10; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16590-312-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16590-312-30)</PackageDescription>
<NDC11Code>16590-0312-30</NDC11Code>
<ProductNDC>16590-312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diovan Hct</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide, Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060428</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020818</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; VALSARTAN</SubstanceName>
<StrengthNumber>12.5; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.</IndicationAndUsage>
<Description>Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>16714-312-02</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (16714-312-02)</PackageDescription>
<NDC11Code>16714-0312-02</NDC11Code>
<ProductNDC>16714-312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078932</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-29</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>33342-312-07</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-312-07) </PackageDescription>
<NDC11Code>33342-0312-07</NDC11Code>
<ProductNDC>33342-312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine And Donepezil</ProprietaryName>
<NonProprietaryName>Memantine And Donepezil</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208672</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>14; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.</IndicationAndUsage>
<Description>Memantine and donepezil hydrochlorides extended-release capsules contain memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine HydrochlorideThe chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac.</Description>
</NDC>
</NDCList>