Home NDC 85477-322 Embriva
Product NDC 85477-322
11-digit product format 854770322
Labeler code 85477
Product ID 85477-322_3c362de4-1eda-83be-e063-6394a90a10fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDE
Dosage form TABLET
Route ORAL
Labeler Oncora Pharma, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2025-08-08
Substance PYRIDOXAL PHOSPHATE ANHYDROUS; POTASSIUM IODIDE; ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE; FOLIC ACID; METHYLCOBALAMIN; CALCIUM CARBONATE; FERROUS GLUCONATE
Active strength 2.5; .15; 125; .0125; 1.4; 1; 1; 200; 13 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Embriva
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PYRIDOXAL PHOSPHATE ANHYDROUS 2.5 mg/1 POTASSIUM IODIDE .15 mg/1 ASCORBIC ACID 125 mg/1 CHOLECALCIFEROL .0125 mg/1 THIAMINE 1.4 mg/1 FOLIC ACID 1 mg/1 METHYLCOBALAMIN 1 mg/1 CALCIUM CARBONATE 200 mg/1 FERROUS GLUCONATE 13 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 9 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85477-322-30 Embriva 30 in 1 BOTTLE, PLASTIC TABLET 30 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Embriva ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDE Oncora Pharma, LLC 3c362de4-1ed9-83be-e063-6394a90a10fc 2025-08-12 Warnings Exact identifier ndc (product): 85477-322
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85477-322-30 85477032230 30 TABLET in 1 BOTTLE, PLASTIC (85477-322-30) 30 tablet 2025-08-08 No No Current