{
"NDC": [
{
"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": "75854-104-30",
"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": "75854-312-30",
"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": "75854-313-30",
"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": "75854-320-30",
"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": "13537-319-02",
"PackageDescription": "1 JAR in 1 BOX (13537-319-02) > 30 g in 1 JAR (13537-319-01)",
"NDC11Code": "13537-0319-02",
"ProductNDC": "13537-319",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika",
"ProprietaryNameSuffix": "Hydrated Face Makeup Foundation Spf 15",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110517",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation (San Juan, P.R)",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".06",
"StrengthUnit": "g/g",
"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": "16590-319-30",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (16590-319-30)",
"NDC11Code": "16590-0319-30",
"ProductNDC": "16590-319",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "19890428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072579",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "I. Vasospastic Angina: Nifedipine is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or when angina is refractory to nitrates and/or adequate doses of beta blockers. ll. Chronic Stable Angina (Classical Effort-Associated Angina): Nifedipine is indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents. In chronic stable angina (effort-associated angina) nifedipine has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients are incomplete. Controlled studies in small numbers of patients suggest concomitant use of nifedipine and beta-blocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely since severe hypotension can occur from the combined effects of the drugs. (See WARNINGS.).",
"Description": "Nifedipine is an antianginal drug belonging to a class of pharmacological agents, the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2, 6-dimethyl -4-(2-nitrophenyl)-, dimethyl ester, C17H18N206 and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine capsules are formulated as soft gelatin capsules for oral administration each containing 10 mg or 20 mg nifedipine. Inactive Ingredients: Nifedipine capsules for oral administration contain the following inactive ingredients: glycerin, peppermint oil, and polyethylene glycol. The 10 mg capsule shell contains gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow, propylene glycol, and titanium dioxide. The 20 mg capsule shell contains FD and C red #40, FD and C yellow #6 (sunset yellow), gelatin, glycerin, hypromellose, iron oxide black, iron oxide brown, iron oxide red, propylene glycol, and titanium dioxide."
},
{
"NDCCode": "16729-319-10",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-319-10)",
"NDC11Code": "16729-0319-10",
"ProductNDC": "16729-319",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxybutynin Chloride",
"NonProprietaryName": "Oxybutynin Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161010",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207138",
"LabelerName": "Accord Healthcare, Inc.",
"SubstanceName": "OXYBUTYNIN CHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-22"
},
{
"NDCCode": "21695-319-30",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (21695-319-30)",
"NDC11Code": "21695-0319-30",
"ProductNDC": "21695-319",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ambien Cr",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021774",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ambien CR (zolpidem tartrate extended-release tablets) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see Clinical Studies (14)].",
"Description": "Ambien CR contains zolpidem tartrate, a non-benzodiazepine hypnotic of the imidazopyridine class. Ambien CR (zolpidem tartrate extended-release tablets) is available in 6.25 mg and 12.5 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Ambien CR consists of a coated two-layer tablet: one layer that releases its drug content immediately and another layer that allows a slower release of additional drug content. The 6.25 mg Ambien CR tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, red ferric oxide, sodium starch glycolate, and titanium dioxide. The 12.5 mg Ambien CR tablet contains the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, sodium starch glycolate, titanium dioxide, and yellow ferric oxide."
},
{
"NDCCode": "31722-319-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-319-30) ",
"NDC11Code": "31722-0319-30",
"ProductNDC": "31722-319",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paliperidone",
"NonProprietaryName": "Paliperidone",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216174",
"LabelerName": "Camber Pharmaceuticals, Inc",
"SubstanceName": "PALIPERIDONE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230823",
"SamplePackage": "N",
"Description": "Paliperidone extended-release tablets contain paliperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone extended-release tablets contain a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.48. The structural formula is. Paliperidone, USP is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (beige), 3 mg (pink), 6 mg (beige), and 9 mg (yellow) strengths. Paliperidone extended-release tablets utilize OROS® osmotic drug-release technology. Inactive ingredients are lactose monohydrate, sodium chloride, hydroxypropyl methyl cellulose, polyethylene oxides, stearic acid, FD & C Red No. 40, povidone, magnesium stearate, hydroxypropyl cellulose, cellulose acetate, polyethylene glycol, ferrosoferric oxide, propylene glycol, and titanium dioxide. The 1.5 mg and 6 mg strengths also contain iron oxide yellow and iron oxide red. The 3 mg strength also contain iron oxide red. The 9 mg strength also contain iron oxide yellow and polysorbate 80. Delivery System Components and Performance. Paliperidone extended-release tablets use osmotic pressure to deliver paliperidone at a controlled rate. The delivery system, which resembles a capsule-shaped tablet in appearance, consists of an osmotically active trilayer core surrounded by a subcoat and semipermeable membrane. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There are two precision laser-drilled orifices on the drug-layer dome of the tablet. Each tablet strength has a different colored water-dispersible overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible color overcoat erodes quickly. Water then enters the tablet through the semipermeable membrane that controls the rate at which water enters the tablet core, which, in turn, determines the rate of drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifices. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, along with insoluble core components."
},
{
"NDCCode": "36800-319-39",
"PackageDescription": "1 BOTTLE in 1 CARTON (36800-319-39) > 30 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "36800-0319-39",
"ProductNDC": "36800-319",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare Allergy Relief",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076447",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N"
},
{
"NDCCode": "37835-319-30",
"PackageDescription": "355 mL in 1 BOTTLE, PLASTIC (37835-319-30) ",
"NDC11Code": "37835-0319-30",
"ProductNDC": "37835-319",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Sleep Aid",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20210429",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M010",
"LabelerName": "Bi-Mart",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/30mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210429",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep."
},
{
"NDCCode": "42254-319-30",
"PackageDescription": "1 TUBE in 1 CARTON (42254-319-30) > 28.4 g in 1 TUBE",
"NDC11Code": "42254-0319-30",
"ProductNDC": "42254-319",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Miconazole Nitrate",
"NonProprietaryName": "Miconazole Nitrate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20030901",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "MICONAZOLE NITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). relieves itching, scaling, cracking, burning and discomfort associated with those conditions."
}
]
}
{"NDC":[{"NDCCode":"75854-319-30","ProprietaryName":"Feriva Fa","NonProprietaryName":"Ferrous Bisglycinate, Ferrous Asparto Glycinate, Ferrous Fumarate, Ascorbic Acid, Folic Acid, Cyanocobalamin, Biotin, Cupric Oxide And Docusate Sodium"},{"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 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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":"75854-312-30","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":"75854-313-30","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 Calcium, Calcium Formate, Ferrous Asparto Glycinate, Cyanocobalamin, Biotin, Potassium Iodide, Magnesium Oxide, Zinc Oxide And Cupric Oxide"},{"NDCCode":"75854-315-30","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"},{"NDCCode":"75854-316-30","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"},{"NDCCode":"75854-320-30","ProprietaryName":"Chromagen","NonProprietaryName":"Ferrous Asparto Glycinate, Ferrous Fumarate, Ascorbic Acid, Folic Acid, Levomefolate Glucosamine, Cyanocobalamin, Zinc, And Intrinsic Factor"},{"NDCCode":"75854-321-30","ProprietaryName":"Niferex","NonProprietaryName":"Ferrous Asparto Glycinate, Iron, Ascorbic Acid, Folic Acid, Cyanocobalamin, Zinc, Succinic Acid, And Intrinsic Factor"},{"NDCCode":"75854-322-30","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"},{"NDCCode":"75854-344-30","ProprietaryName":"Niferex","NonProprietaryName":"Ferrous Asparto Glycinate, Iron, Ascorbic Acid, Folic Acid, Cyanocobalamin, Zinc, And Succinic Acid"},{"NDCCode":"13537-319-02","ProprietaryName":"Esika","NonProprietaryName":"Octinoxate"},{"NDCCode":"16590-319-30","ProprietaryName":"Nifedipine","NonProprietaryName":"Nifedipine"},{"NDCCode":"16729-319-10","ProprietaryName":"Oxybutynin Chloride","NonProprietaryName":"Oxybutynin Chloride"},{"NDCCode":"21695-319-30","ProprietaryName":"Ambien Cr","NonProprietaryName":"Zolpidem Tartrate"},{"NDCCode":"31722-319-30","ProprietaryName":"Paliperidone","NonProprietaryName":"Paliperidone"},{"NDCCode":"36800-319-39","ProprietaryName":"Topcare Allergy Relief","NonProprietaryName":"Fexofenadine Hydrochloride"},{"NDCCode":"37835-319-30","ProprietaryName":"Nighttime Sleep Aid","NonProprietaryName":"Diphenhydramine Hcl"},{"NDCCode":"42254-319-30","ProprietaryName":"Miconazole Nitrate","NonProprietaryName":"Miconazole Nitrate"}]}
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<NDCList>
<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>75854-104-30</NDCCode>
<PackageDescription>30 BOX in 1 CARTON (75854-104-30) > 3.7 g in 1 BOX</PackageDescription>
<NDC11Code>75854-0104-30</NDC11Code>
<ProductNDC>75854-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosula</ProprietaryName>
<NonProprietaryName>Sodium Sulfacetamide 10% And Sulfur 5%</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150313</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75854-301-30</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (75854-301-30) </PackageDescription>
<NDC11Code>75854-0301-30</NDC11Code>
<ProductNDC>75854-301</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, Cyanocobalamin, Biotin, Calcium Pantothenate, Calcium Carbonate, Ferrous Fumarate, Potassium Iodide, Magnesium Oxide, Zinc Oxide And Cupric Oxide</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120806</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<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</SubstanceName>
<StrengthNumber>2600; 75; 450; 10; 3; 3.5; 21; 21; 1; 13; 330; 6; 100; 26; 150; 25; 15; 1.5</StrengthNumber>
<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</StrengthUnit>
<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>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75854-302-30</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (75854-302-30) > 30 CAPSULE, GELATIN COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>75854-0302-30</NDC11Code>
<ProductNDC>75854-302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenate Dha</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide And Doconexent</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120131</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; MAGNESIUM OXIDE; DOCONEXENT</SubstanceName>
<StrengthNumber>90; 220; 10; 26; 1; 13; 145; 28; 50; 300</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; [iU]/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>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75854-303-30</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (75854-303-30) > 30 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>75854-0303-30</NDC11Code>
<ProductNDC>75854-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenate Essential</ProprietaryName>
<NonProprietaryName>- Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Carbonate, Ferrous Fumarate, Potassium Iodide, Magnesium Oxide, Doconexent And Icosapent</NonProprietaryName>
<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>
<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</StrengthUnit>
<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>
</NDC>
<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>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<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>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<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>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121230</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>FERROUS BISGLYCINATE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; BIOTIN</SubstanceName>
<StrengthNumber>75; 175; 1; 120; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; ug/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>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>
<ProductNDC>75854-306</ProductNDC>
<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>
<StrengthUnit>mg/1; ug/1; mg/1; ug/1; ug/1; mg/1; ug/1; ug/1; mg/1; ug/1</StrengthUnit>
<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>
</NDC>
<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>75854-312-30</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-312-30) </PackageDescription>
<NDC11Code>75854-0312-30</NDC11Code>
<ProductNDC>75854-312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenate Dha</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Folic Acid, Levomefolate Calcium, Pyridoxine Hydrochloride, Cyanocobalamin, Calcium Formate, Ferrous Asparto Glycinate, Magnesium Oxide And Doconexent</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140605</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVOMEFOLATE CALCIUM; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM FORMATE; FERROUS ASPARTO GLYCINATE; MAGNESIUM OXIDE; DOCONEXENT</SubstanceName>
<StrengthNumber>600; 90; 10; 18; 400; 26; 25; 160; 18; 50; 300</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; ug/1; mg/1; ug/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], 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 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.</IndicationAndUsage>
<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.</Description>
</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>75854-320-30</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>13537-319-02</NDCCode>
<PackageDescription>1 JAR in 1 BOX (13537-319-02) > 30 g in 1 JAR (13537-319-01)</PackageDescription>
<NDC11Code>13537-0319-02</NDC11Code>
<ProductNDC>13537-319</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika</ProprietaryName>
<ProprietaryNameSuffix>Hydrated Face Makeup Foundation Spf 15</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>POWDER</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</SubstanceName>
<StrengthNumber>.06</StrengthNumber>
<StrengthUnit>g/g</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>16590-319-30</NDCCode>
<PackageDescription>30 CAPSULE, LIQUID FILLED in 1 BOTTLE (16590-319-30)</PackageDescription>
<NDC11Code>16590-0319-30</NDC11Code>
<ProductNDC>16590-319</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedipine</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19890428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072579</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>I. Vasospastic Angina: Nifedipine is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or when angina is refractory to nitrates and/or adequate doses of beta blockers. ll. Chronic Stable Angina (Classical Effort-Associated Angina): Nifedipine is indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents. In chronic stable angina (effort-associated angina) nifedipine has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients are incomplete. Controlled studies in small numbers of patients suggest concomitant use of nifedipine and beta-blocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely since severe hypotension can occur from the combined effects of the drugs. (See WARNINGS.).</IndicationAndUsage>
<Description>Nifedipine is an antianginal drug belonging to a class of pharmacological agents, the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2, 6-dimethyl -4-(2-nitrophenyl)-, dimethyl ester, C17H18N206 and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine capsules are formulated as soft gelatin capsules for oral administration each containing 10 mg or 20 mg nifedipine. Inactive Ingredients: Nifedipine capsules for oral administration contain the following inactive ingredients: glycerin, peppermint oil, and polyethylene glycol. The 10 mg capsule shell contains gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow, propylene glycol, and titanium dioxide. The 20 mg capsule shell contains FD and C red #40, FD and C yellow #6 (sunset yellow), gelatin, glycerin, hypromellose, iron oxide black, iron oxide brown, iron oxide red, propylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>16729-319-10</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-319-10)</PackageDescription>
<NDC11Code>16729-0319-10</NDC11Code>
<ProductNDC>16729-319</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxybutynin Chloride</ProprietaryName>
<NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161010</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207138</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.</LabelerName>
<SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>21695-319-30</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (21695-319-30)</PackageDescription>
<NDC11Code>21695-0319-30</NDC11Code>
<ProductNDC>21695-319</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ambien Cr</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090630</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021774</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ambien CR (zolpidem tartrate extended-release tablets) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Ambien CR contains zolpidem tartrate, a non-benzodiazepine hypnotic of the imidazopyridine class. Ambien CR (zolpidem tartrate extended-release tablets) is available in 6.25 mg and 12.5 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Ambien CR consists of a coated two-layer tablet: one layer that releases its drug content immediately and another layer that allows a slower release of additional drug content. The 6.25 mg Ambien CR tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, red ferric oxide, sodium starch glycolate, and titanium dioxide. The 12.5 mg Ambien CR tablet contains the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, sodium starch glycolate, titanium dioxide, and yellow ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>31722-319-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-319-30) </PackageDescription>
<NDC11Code>31722-0319-30</NDC11Code>
<ProductNDC>31722-319</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paliperidone</ProprietaryName>
<NonProprietaryName>Paliperidone</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216174</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc</LabelerName>
<SubstanceName>PALIPERIDONE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Paliperidone extended-release tablets contain paliperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone extended-release tablets contain a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.48. The structural formula is. Paliperidone, USP is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (beige), 3 mg (pink), 6 mg (beige), and 9 mg (yellow) strengths. Paliperidone extended-release tablets utilize OROS® osmotic drug-release technology. Inactive ingredients are lactose monohydrate, sodium chloride, hydroxypropyl methyl cellulose, polyethylene oxides, stearic acid, FD & C Red No. 40, povidone, magnesium stearate, hydroxypropyl cellulose, cellulose acetate, polyethylene glycol, ferrosoferric oxide, propylene glycol, and titanium dioxide. The 1.5 mg and 6 mg strengths also contain iron oxide yellow and iron oxide red. The 3 mg strength also contain iron oxide red. The 9 mg strength also contain iron oxide yellow and polysorbate 80. Delivery System Components and Performance. Paliperidone extended-release tablets use osmotic pressure to deliver paliperidone at a controlled rate. The delivery system, which resembles a capsule-shaped tablet in appearance, consists of an osmotically active trilayer core surrounded by a subcoat and semipermeable membrane. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There are two precision laser-drilled orifices on the drug-layer dome of the tablet. Each tablet strength has a different colored water-dispersible overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible color overcoat erodes quickly. Water then enters the tablet through the semipermeable membrane that controls the rate at which water enters the tablet core, which, in turn, determines the rate of drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifices. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, along with insoluble core components.</Description>
</NDC>
<NDC>
<NDCCode>36800-319-39</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (36800-319-39) > 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>36800-0319-39</NDC11Code>
<ProductNDC>36800-319</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare Allergy Relief</ProprietaryName>
<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076447</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37835-319-30</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE, PLASTIC (37835-319-30) </PackageDescription>
<NDC11Code>37835-0319-30</NDC11Code>
<ProductNDC>37835-319</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighttime Sleep Aid</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210429</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M010</ApplicationNumber>
<LabelerName>Bi-Mart</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42254-319-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (42254-319-30) > 28.4 g in 1 TUBE</PackageDescription>
<NDC11Code>42254-0319-30</NDC11Code>
<ProductNDC>42254-319</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Miconazole Nitrate</ProprietaryName>
<NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20030901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>MICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). relieves itching, scaling, cracking, burning and discomfort associated with those conditions.</IndicationAndUsage>
</NDC>
</NDCList>