prenate elite

Generic: .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

Labeler: avion pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand 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
Labeler avion pharmaceuticals, llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

.alpha.-tocopherol acetate, dl- 40 [iU]/1, .beta.-carotene 2600 [iU]/1, 5-methyltetrahydrofolic acid 600 ug/1, ascorbic acid 75 mg/1, biotin 330 ug/1, calcium formate 155 mg/1, cholecalciferol 600 [iU]/1, cupric oxide 1.5 mg/1, cyanocobalamin 13 ug/1, ferrous asparto glycinate 20 mg/1, folic acid 400 ug/1, magnesium oxide 25 mg/1, niacinamide 21 mg/1, potassium iodide 150 ug/1, pyridoxine hydrochloride 21 mg/1, riboflavin 3.5 mg/1, thiamine mononitrate 3 mg/1, zinc oxide 15 mg/1

Manufacturer
Avion Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 75854-314
Product ID 75854-314_894ca429-22b4-4b42-b732-bdeb40bcfacd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2014-06-05

Pharmacologic Class

Established (EPC)
vitamin c [epc] vitamin d [epc] vitamin b12 [epc]
Chemical Structure
ascorbic acid [cs] vitamin d [cs] vitamin b 12 [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75854314
Hyphenated Format 75854-314

Supplemental Identifiers

UPC
0375854314307
UNII
WR1WPI7EW8 TYK22LML8F PQ6CK8PD0R 6SO6U10H04 NP3JD65NPY 1C6V77QF41 V1XJQ704R4 P6YC3EG204 H7426RGB3L 935E97BOY8 3A3U0GI71G 25X51I8RD4 1C4QK22F9J 68Y4CF58BV TLM2976OFR 8K0I04919X SOI2LOH54Z
NUI
N0000193618 M0001797 M0022797 N0000175952 M0022794 N0000175951

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name prenate elite (source: ndc)
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 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 ug/1
  • 40 [iU]/1
  • 75 mg/1
  • 2600 [iU]/1
  • 330 ug/1
  • 155 mg/1
  • 600 [iU]/1
  • 1.5 mg/1
  • 13 ug/1
  • 20 mg/1
  • 400 ug/1
  • 25 mg/1
  • 21 mg/1
  • 150 ug/1
  • 3.5 mg/1
  • 3 mg/1
  • 15 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (75854-314-30)
source: ndc

Packages (1)

75854-314-30 30 TABLET, COATED in 1 BOTTLE (75854-314-30)

Ingredients (18)

5-methyltetrahydrofolic acid (600 ug/1) .alpha.-tocopherol acetate, dl- (40 [iU]/1) ascorbic acid (75 mg/1) .beta.-carotene (2600 [iU]/1) biotin (330 ug/1) calcium formate (155 mg/1) cholecalciferol (600 [iU]/1) cupric oxide (1.5 mg/1) cyanocobalamin (13 ug/1) ferrous asparto glycinate (20 mg/1) folic acid (400 ug/1) magnesium oxide (25 mg/1) niacinamide (21 mg/1) potassium iodide (150 ug/1) pyridoxine hydrochloride (21 mg/1) riboflavin (3.5 mg/1) thiamine mononitrate (3 mg/1) zinc oxide (15 mg/1)

Linked Drug Pages (1)

Prenate Elite ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "894ca429-22b4-4b42-b732-bdeb40bcfacd", "openfda": {"nui": ["N0000193618", "M0001797", "M0022797", "N0000175952", "M0022794", "N0000175951"], "upc": ["0375854314307"], "unii": ["WR1WPI7EW8", "TYK22LML8F", "PQ6CK8PD0R", "6SO6U10H04", "NP3JD65NPY", "1C6V77QF41", "V1XJQ704R4", "P6YC3EG204", "H7426RGB3L", "935E97BOY8", "3A3U0GI71G", "25X51I8RD4", "1C4QK22F9J", "68Y4CF58BV", "TLM2976OFR", "8K0I04919X", "SOI2LOH54Z"], "spl_set_id": ["9b79c950-4312-4a53-9e36-fb8e00b053df"], "pharm_class_cs": ["Ascorbic Acid [CS]", "Vitamin D [CS]", "Vitamin B 12 [CS]"], "pharm_class_epc": ["Vitamin C [EPC]", "Vitamin D [EPC]", "Vitamin B12 [EPC]"], "manufacturer_name": ["Avion Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (75854-314-30)", "package_ndc": "75854-314-30", "marketing_start_date": "20140605"}], "brand_name": "Prenate Elite", "product_id": "75854-314_894ca429-22b4-4b42-b732-bdeb40bcfacd", "dosage_form": "TABLET, COATED", "pharm_class": ["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]", "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]"], "product_ndc": "75854-314", "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", "labeler_name": "Avion Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prenate Elite", "active_ingredients": [{"name": ".ALPHA.-TOCOPHEROL ACETATE, DL-", "strength": "40 [iU]/1"}, {"name": ".BETA.-CAROTENE", "strength": "2600 [iU]/1"}, {"name": "5-METHYLTETRAHYDROFOLIC ACID", "strength": "600 ug/1"}, {"name": "ASCORBIC ACID", "strength": "75 mg/1"}, {"name": "BIOTIN", "strength": "330 ug/1"}, {"name": "CALCIUM FORMATE", "strength": "155 mg/1"}, {"name": "CHOLECALCIFEROL", "strength": "600 [iU]/1"}, {"name": "CUPRIC OXIDE", "strength": "1.5 mg/1"}, {"name": "CYANOCOBALAMIN", "strength": "13 ug/1"}, {"name": "FERROUS ASPARTO GLYCINATE", "strength": "20 mg/1"}, {"name": "FOLIC ACID", "strength": "400 ug/1"}, {"name": "MAGNESIUM OXIDE", "strength": "25 mg/1"}, {"name": "NIACINAMIDE", "strength": "21 mg/1"}, {"name": "POTASSIUM IODIDE", "strength": "150 ug/1"}, {"name": "PYRIDOXINE HYDROCHLORIDE", "strength": "21 mg/1"}, {"name": "RIBOFLAVIN", "strength": "3.5 mg/1"}, {"name": "THIAMINE MONONITRATE", "strength": "3 mg/1"}, {"name": "ZINC OXIDE", "strength": "15 mg/1"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20140605", "listing_expiration_date": "20261231"}