{
"NDC": [
{
"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": "75854-310-03",
"PackageDescription": "3 CAPSULE, GELATIN COATED in 1 PACKET (75854-310-03) ",
"NDC11Code": "75854-0310-03",
"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": "75854-104-30",
"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": "75854-311-30",
"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": "75854-319-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-319-30) ",
"NDC11Code": "75854-0319-30",
"ProductNDC": "75854-319",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Feriva Fa",
"NonProprietaryName": "Ferrous Bisglycinate, Ferrous Asparto Glycinate, Ferrous Fumarate, Ascorbic Acid, Folic Acid, Cyanocobalamin, Biotin, Cupric Oxide And Docusate Sodium",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "FERROUS BISGLYCINATE; FERROUS ASPARTO GLYCINATE; FERROUS FUMARATE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CUPRIC OXIDE; DOCUSATE SODIUM",
"StrengthNumber": "36.7; 36.7; 36.7; 175; 1; 12; 300; 1.5; 50",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B 12 [CS],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150101",
"SamplePackage": "N"
},
{
"NDCCode": "75854-320-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (75854-320-30) ",
"NDC11Code": "75854-0320-30",
"ProductNDC": "75854-320",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chromagen",
"NonProprietaryName": "Ferrous Asparto Glycinate, Ferrous Fumarate, Ascorbic Acid, Folic Acid, Levomefolate Glucosamine, Cyanocobalamin, Zinc, And Intrinsic Factor",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170110",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "FERROUS ASPARTO GLYCINATE; FERROUS FUMARATE; ASCORBIC ACID; LEVOMEFOLATE GLUCOSAMINE; FOLIC ACID; CYANOCOBALAMIN; ZINC; INTRINSIC FACTOR",
"StrengthNumber": "25; 50; 60; 750; 250; 10; 12; 100",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170123",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS: Chromagen is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.",
"Description": "DESCRIPTION: Chromagen for oral administration is an iron supplement softgel that is pearlescent dark blue and embossed with “CH75” on one side."
},
{
"NDCCode": "75854-321-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (75854-321-30) ",
"NDC11Code": "75854-0321-30",
"ProductNDC": "75854-321",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niferex",
"NonProprietaryName": "Ferrous Asparto Glycinate, Iron, Ascorbic Acid, Folic Acid, Cyanocobalamin, Zinc, Succinic Acid, And Intrinsic Factor",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170110",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals, LLC",
"SubstanceName": "ASCORBIC ACID; CYANOCOBALAMIN; FERROUS ASPARTO GLYCINATE; FOLIC ACID; INTRINSIC FACTOR; IRON DEXTRAN; LEVOMEFOLIC ACID; SUCCINIC ACID; ZINC",
"StrengthNumber": "60; 25; 50; 250; 100; 100; 750; 50; 15",
"StrengthUnit": "mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170110",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS: Niferex is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.",
"Description": "DESCRIPTION: Niferex for oral administrationis a prenatal/postnatal iron supplement that is a round, copper colored tablet with \"NxFE\" embossed on one side."
},
{
"NDCCode": "75854-322-30",
"PackageDescription": "30 PILL in 1 BOTTLE (75854-322-30) ",
"NDC11Code": "75854-0322-30",
"ProductNDC": "75854-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Primacare",
"NonProprietaryName": "Calcium Ascorbate Dihydrate, Cholecalciferol, Dl-a Tocopheryl Acetate, Riboflavin, Niacinamide, Folate, Biotin, Calcium, Ferrous Asparto Glycinate, Potassium Iodide, Magnesium Oxide, Zinc Bisglycinate Chelate, Alpha Linoleic Acid, Dha, Epa",
"DosageFormName": "PILL",
"RouteName": "ORAL",
"StartMarketingDate": "20170123",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Avion Pharmaceuticals",
"SubstanceName": "ALPHA-TOCOPHEROL ACETATE; BIOTIN; CALCIUM ASCORBATE; CALCIUM CARBONATE; CHOLECALCIFEROL; FOLIC ACID; LINOLEIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; OMEGA-3 FATTY ACIDS; POTASSIUM IODIDE; PYRIDOXINE; RIBOFLAVIN; ZINC",
"StrengthNumber": "15; 1; 25; 100; 1000; 1; 50; 50; 10; 420; 150; 50; 1.5; 15",
"StrengthUnit": "[iU]/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Fatty Acids, Omega-3 [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Omega-3 Fatty Acid [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
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"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": "11673-310-30",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (11673-310-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "11673-0310-30",
"ProductNDC": "11673-310",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20240315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210088",
"LabelerName": "TARGET CORPORATION",
"SubstanceName": "LORATADINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240315",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
},
{
"NDCCode": "13537-310-02",
"PackageDescription": "1 BOTTLE in 1 BOX (13537-310-02) > 30 mL in 1 BOTTLE (13537-310-01)",
"NDC11Code": "13537-0310-02",
"ProductNDC": "13537-310",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika",
"ProprietaryNameSuffix": "Hydro-nutrative Foundation Spf 13",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110517",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation (San Juan, P.R)",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".05; .02",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides moderate protection against sunburn."
},
{
"NDCCode": "13668-310-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (13668-310-30) ",
"NDC11Code": "13668-0310-30",
"ProductNDC": "13668-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207677",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151223",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3), 4 Ankylosing Spondylitis (AS) (1.4), 5 Acute Pain (AP) (1.5), 6 Primary Dysmenorrhea (PD) (1.6).",
"Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib, USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzene sulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib, USP is a white or almost white, crystalline powder with a pKa of 11. Celecoxib is freely soluble in ethanol, soluble in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsule include: croscarmellose sodium, lactose monohydrate DCL 11, magnesium stearate, povidone (K 30) and sodium lauryl sulfate. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 50 mg capsule shell contain iron oxide red, 100 mg capsule shell contain FD&C blue 1 and FD&C red 40, 200 mg capsule shell contain iron oxide yellow and 400 mg capsule shell contain FD&C blue 2 and iron oxide yellow. The imprinting ink contains iron oxide black, propylene glycol, potassium hydroxide, povidone, shellac, sodium hydroxide and titanium dioxide."
},
{
"NDCCode": "14141-188-01",
"PackageDescription": "9 g in 1 JAR (14141-188-01) ",
"NDC11Code": "14141-0188-01",
"ProductNDC": "14141-188",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clarite Makeup For A Cleaner Appearance Spf 30 310-c",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200324",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "BEL STAR S A",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "7.5; 7.84",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200324",
"SamplePackage": "N"
},
{
"NDCCode": "14141-211-01",
"PackageDescription": "9 g in 1 CASE (14141-211-01) ",
"NDC11Code": "14141-0211-01",
"ProductNDC": "14141-211",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clarite Makeup Foundation For A Clearer Appearance Spf 30 310-c",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201109",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "BEL STAR S A",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "7.5; 7.84",
"StrengthUnit": "g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201109",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctorif rash occurs."
},
{
"NDCCode": "14783-261-01",
"PackageDescription": "9 g in 1 CASE (14783-261-01) ",
"NDC11Code": "14783-0261-01",
"ProductNDC": "14783-261",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clarite Makeup Foundation For A Clearer Appearance Spf 30 310-c",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201109",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "7.5; 7.84",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201109",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
},
{
"NDCCode": "24658-310-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (24658-310-30) ",
"NDC11Code": "24658-0310-30",
"ProductNDC": "24658-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062269",
"LabelerName": "PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-04-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250414",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate tablets for oral administration. The chemical designation of doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Active Ingredient: Doxycycline hyclate USP equivalent to 50 mg or 100 mg of doxycycline. Inactive Ingredient: Microcrystalline cellulose and magnesium stearate. Tablet coating contains hypromellose, titanium dioxide, polyethylene glycol, FD&C yellow #6, polysorbate 80 and FD&C blue #2. Meet USP Dissolution Test 5."
}
]
}
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<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>75854-104-30</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>75854-311-30</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>75854-319-30</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-319-30) </PackageDescription>
<NDC11Code>75854-0319-30</NDC11Code>
<ProductNDC>75854-319</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Feriva Fa</ProprietaryName>
<NonProprietaryName>Ferrous Bisglycinate, Ferrous Asparto Glycinate, Ferrous Fumarate, Ascorbic Acid, Folic Acid, Cyanocobalamin, Biotin, Cupric Oxide And Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>FERROUS BISGLYCINATE; FERROUS ASPARTO GLYCINATE; FERROUS FUMARATE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CUPRIC OXIDE; DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>36.7; 36.7; 36.7; 175; 1; 12; 300; 1.5; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B 12 [CS],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75854-320-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (75854-320-30) </PackageDescription>
<NDC11Code>75854-0320-30</NDC11Code>
<ProductNDC>75854-320</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chromagen</ProprietaryName>
<NonProprietaryName>Ferrous Asparto Glycinate, Ferrous Fumarate, Ascorbic Acid, Folic Acid, Levomefolate Glucosamine, Cyanocobalamin, Zinc, And Intrinsic Factor</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>FERROUS ASPARTO GLYCINATE; FERROUS FUMARATE; ASCORBIC ACID; LEVOMEFOLATE GLUCOSAMINE; FOLIC ACID; CYANOCOBALAMIN; ZINC; INTRINSIC FACTOR</SubstanceName>
<StrengthNumber>25; 50; 60; 750; 250; 10; 12; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS: Chromagen is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.</IndicationAndUsage>
<Description>DESCRIPTION: Chromagen for oral administration is an iron supplement softgel that is pearlescent dark blue and embossed with “CH75” on one side.</Description>
</NDC>
<NDC>
<NDCCode>75854-321-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (75854-321-30) </PackageDescription>
<NDC11Code>75854-0321-30</NDC11Code>
<ProductNDC>75854-321</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niferex</ProprietaryName>
<NonProprietaryName>Ferrous Asparto Glycinate, Iron, Ascorbic Acid, Folic Acid, Cyanocobalamin, Zinc, Succinic Acid, And Intrinsic Factor</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; CYANOCOBALAMIN; FERROUS ASPARTO GLYCINATE; FOLIC ACID; INTRINSIC FACTOR; IRON DEXTRAN; LEVOMEFOLIC ACID; SUCCINIC ACID; ZINC</SubstanceName>
<StrengthNumber>60; 25; 50; 250; 100; 100; 750; 50; 15</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS: Niferex is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.</IndicationAndUsage>
<Description>DESCRIPTION: Niferex for oral administrationis a prenatal/postnatal iron supplement that is a round, copper colored tablet with "NxFE" embossed on one side.</Description>
</NDC>
<NDC>
<NDCCode>75854-322-30</NDCCode>
<PackageDescription>30 PILL in 1 BOTTLE (75854-322-30) </PackageDescription>
<NDC11Code>75854-0322-30</NDC11Code>
<ProductNDC>75854-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Primacare</ProprietaryName>
<NonProprietaryName>Calcium Ascorbate Dihydrate, Cholecalciferol, Dl-a Tocopheryl Acetate, Riboflavin, Niacinamide, Folate, Biotin, Calcium, Ferrous Asparto Glycinate, Potassium Iodide, Magnesium Oxide, Zinc Bisglycinate Chelate, Alpha Linoleic Acid, Dha, Epa</NonProprietaryName>
<DosageFormName>PILL</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170123</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals</LabelerName>
<SubstanceName>ALPHA-TOCOPHEROL ACETATE; BIOTIN; CALCIUM ASCORBATE; CALCIUM CARBONATE; CHOLECALCIFEROL; FOLIC ACID; LINOLEIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; OMEGA-3 FATTY ACIDS; POTASSIUM IODIDE; PYRIDOXINE; RIBOFLAVIN; ZINC</SubstanceName>
<StrengthNumber>15; 1; 25; 100; 1000; 1; 50; 50; 10; 420; 150; 50; 1.5; 15</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Fatty Acids, Omega-3 [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Omega-3 Fatty Acid [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170123</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS: PrimaCare is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of omen throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.</IndicationAndUsage>
<Description>DESCRIPTION: PrimaCare is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color and imprinted with “PRIMA” on one side and blank on the other.'. PrimaCare contains flaxseed oil, fish oil and soy. OTHER INGREDIENTS: Gelatin capsule (bovine gelatin, sorbitol, glycerin, purified water, titanium dioxide, FD&C Red #40, caramel coloring, FD&C Blue #1), yellow beeswax and soy lecithin.</Description>
</NDC>
<NDC>
<NDCCode>75854-344-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (75854-344-30) </PackageDescription>
<NDC11Code>75854-0344-30</NDC11Code>
<ProductNDC>75854-344</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niferex</ProprietaryName>
<NonProprietaryName>Ferrous Asparto Glycinate, Iron, Ascorbic Acid, Folic Acid, Cyanocobalamin, Zinc, And Succinic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241216</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
<SubstanceName>FERROUS ASPARTO GLYCINATE; ASCORBIC ACID; LEVOMEFOLATE GLUCOSAMINE; FOLIC ACID; CYANOCOBALAMIN; ZINC; SUCCINIC ACID</SubstanceName>
<StrengthNumber>75; 175; 750; 250; 25; 15; 150</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS: Niferex® is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.</IndicationAndUsage>
<Description>DESCRIPTION: Niferex® for oral administration is an iron supplement that is an oval, copper colored, coated tablet with "344" embossed on one side.</Description>
</NDC>
<NDC>
<NDCCode>11673-310-30</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (11673-310-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11673-0310-30</NDC11Code>
<ProductNDC>11673-310</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210088</ApplicationNumber>
<LabelerName>TARGET CORPORATION</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13537-310-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (13537-310-02) > 30 mL in 1 BOTTLE (13537-310-01)</PackageDescription>
<NDC11Code>13537-0310-02</NDC11Code>
<ProductNDC>13537-310</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika</ProprietaryName>
<ProprietaryNameSuffix>Hydro-nutrative Foundation Spf 13</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110517</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation (San Juan, P.R)</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.05; .02</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides moderate protection against sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13668-310-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (13668-310-30) </PackageDescription>
<NDC11Code>13668-0310-30</NDC11Code>
<ProductNDC>13668-310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207677</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3), 4 Ankylosing Spondylitis (AS) (1.4), 5 Acute Pain (AP) (1.5), 6 Primary Dysmenorrhea (PD) (1.6).</IndicationAndUsage>
<Description>Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib, USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzene sulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib, USP is a white or almost white, crystalline powder with a pKa of 11. Celecoxib is freely soluble in ethanol, soluble in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsule include: croscarmellose sodium, lactose monohydrate DCL 11, magnesium stearate, povidone (K 30) and sodium lauryl sulfate. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 50 mg capsule shell contain iron oxide red, 100 mg capsule shell contain FD&C blue 1 and FD&C red 40, 200 mg capsule shell contain iron oxide yellow and 400 mg capsule shell contain FD&C blue 2 and iron oxide yellow. The imprinting ink contains iron oxide black, propylene glycol, potassium hydroxide, povidone, shellac, sodium hydroxide and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>14141-188-01</NDCCode>
<PackageDescription>9 g in 1 JAR (14141-188-01) </PackageDescription>
<NDC11Code>14141-0188-01</NDC11Code>
<ProductNDC>14141-188</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clarite Makeup For A Cleaner Appearance Spf 30 310-c</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200324</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>BEL STAR S A</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>7.5; 7.84</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>14141-211-01</NDCCode>
<PackageDescription>9 g in 1 CASE (14141-211-01) </PackageDescription>
<NDC11Code>14141-0211-01</NDC11Code>
<ProductNDC>14141-211</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clarite Makeup Foundation For A Clearer Appearance Spf 30 310-c</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>BEL STAR S A</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>7.5; 7.84</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctorif rash occurs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14783-261-01</NDCCode>
<PackageDescription>9 g in 1 CASE (14783-261-01) </PackageDescription>
<NDC11Code>14783-0261-01</NDC11Code>
<ProductNDC>14783-261</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clarite Makeup Foundation For A Clearer Appearance Spf 30 310-c</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>7.5; 7.84</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24658-310-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (24658-310-30) </PackageDescription>
<NDC11Code>24658-0310-30</NDC11Code>
<ProductNDC>24658-310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062269</ApplicationNumber>
<LabelerName>PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate tablets for oral administration. The chemical designation of doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Active Ingredient: Doxycycline hyclate USP equivalent to 50 mg or 100 mg of doxycycline. Inactive Ingredient: Microcrystalline cellulose and magnesium stearate. Tablet coating contains hypromellose, titanium dioxide, polyethylene glycol, FD&C yellow #6, polysorbate 80 and FD&C blue #2. Meet USP Dissolution Test 5.</Description>
</NDC>
</NDCList>