Home FDA labels 5413f02a-91aa-8623-e063-6394a90a56bc Prenate Elite openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
Brand name Prenate Elite
Generic name .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
Manufacturer Avion Pharmaceuticals, LLC
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 9b79c950-4312-4a53-9e36-fb8e00b053df
SPL ID 5413f02a-91aa-8623-e063-6394a90a56bc
Version 8
Effective date 2026-06-12
Source export date 2026-09-28
Source partition 8
Source file https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:55:55 Harmonized routes table Harmonized routes ORAL
Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 25 matching rows.
Type, Scope, Identifier table Type Scope Identifier Source field brand name Prenate Elite openfda.brand_name generic name .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 openfda.generic_name manufacturer name Avion Pharmaceuticals, LLC openfda.manufacturer_name ndc package 75854-314-30 openfda.package_ndc ndc product 75854-314 openfda.product_ndc ndc11 package 75854031430 derived:openfda.package_ndc spl id 5413f02a-91aa-8623-e063-6394a90a56bc id spl set id 9b79c950-4312-4a53-9e36-fb8e00b053df set_id unii 25X51I8RD4 openfda.unii unii TLM2976OFR openfda.unii unii H7426RGB3L openfda.unii unii 935E97BOY8 openfda.unii unii PQ6CK8PD0R openfda.unii unii V1XJQ704R4 openfda.unii unii SOI2LOH54Z openfda.unii unii NP3JD65NPY openfda.unii unii 3A3U0GI71G openfda.unii unii A9R10K3F2F openfda.unii unii 6SO6U10H04 openfda.unii unii P6YC3EG204 openfda.unii unii 1C4QK22F9J openfda.unii unii 8K0I04919X openfda.unii unii WR1WPI7EW8 openfda.unii unii 68Y4CF58BV openfda.unii unii 1C6V77QF41 openfda.unii
Boxed warning cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Boxed warning sections page 1 of 1 · 1 matching rows.
boxed warning WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.