Prenate Elite is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Avion Pharmaceuticals, Llc. The primary component is .beta.-carotene; Ascorbic Acid; Cholecalciferol; .alpha.-tocopherol Acetate, Dl-; Thiamine Mononitrate; Riboflavin; Niacinamide; Pyridoxine Hydrochloride; Folic Acid; 5-methyltetrahydrofolic Acid; Calcium Formate; Ferrous Asparto Glycinate; Cyanocobalamin; Biotin; Potassium Iodide; Magnesium Oxide; Zinc Oxide; Cupric Oxide.
| Product ID | 75854-314_620bb039-d233-a3fb-e053-2a91aa0acc84 |
| NDC | 75854-314 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Prenate Elite |
| Generic Name | .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, 5-methyltetrahydrofolic Acid, Calcium Formate, Ferrous Asparto Glycinate, Cyanocobalamin, Biotin, Potassium Iodide, Magnesium Oxide, Zinc Oxide And Cupric Oxide |
| Dosage Form | Tablet, Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2014-06-05 |
| Marketing Category | UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER |
| Labeler Name | Avion Pharmaceuticals, LLC |
| Substance Name | .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; 5-METHYLTETRAHYDROFOLIC ACID; CALCIUM FORMATE; FERROUS ASPARTO GLYCINATE; CYANOCOBALAMIN; BIOTIN; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE |
| Active Ingredient Strength | 2600 [iU]/1; mg/1; [iU]/1; [iU]/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 | Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Vitamin B 12 [CS],Vitamin B12 [EPC],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] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2014-06-05 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | unapproved drug other |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2014-06-05 |
| Ingredient | Strength |
|---|---|
| .BETA.-CAROTENE | 2600 [iU]/1 |
| SPL SET ID: | 9b79c950-4312-4a53-9e36-fb8e00b053df |
| Manufacturer | |
| UNII |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PRENATE ELITE 76572555 3101227 Live/Registered |
AVION PHARMACEUTICALS, LLC 2004-01-27 |