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Prescription products · Product label record

Embriva drug information

ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDE
Oncora Pharma, LLC · ORAL

Product NDC: 85477-322

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Generic nameASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDE
Labeler / manufacturerOncora Pharma, LLC
RouteORAL
Drug classVitamin C / Vitamin D
Product NDC85477-322
Label effective date2025-08-12

Official product label reference

Embriva — Oncora Pharma, LLC

This page contains 7 source sections for ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDE, oral route. Label set 3c362de4-1ed9-83be-e063-6394a90a10fc, version 1.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

INDICATIONS AND USAGE Prenatal and Postnatal prescriptive Folic Acid
Dosage and administration — label text
DOSAGE AND ADMINISTRATION Usual adult dose is 1 tablet once or twice daily or as prescribed by a licensed practitioner.
Warnings
WARNINGS WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately. Table text from source: | WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.
Product description
DESCRIPTION Each Tablet Contains: Amount per Tablet Thiamine (Vitamin B-1) (from Thiamine Mononitrate) ................. 1.4 mg Ascorbic Acid...................... ......................................................... 125 mg Folic Acid ....................................................................................... 1 mg Colecalciferol ............................................................................. .0125 mg Pyridoxal Phosphate Anhydrous ................................................. 2.5 mg Methylcobalamin.................. ........................................................ 1 mg Calcium Carbonate ................................................................... 200 mg Ferrous Gluconate ..................................................................... 13 mg Potassium Iodide........................................................................ .15 mg Other ingredients: magnesium stearate, microcrystalline cellulose, silicone dioxide
Precautions
PRECAUTIONS Call your licensed medical practitioner about side effects.
Supply and packaging
HOW SUPPLIED Bottles of 30: 85477-0322-30 Storage KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN.
Storage and handling
Storage KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN.

Official sources and product identifiers

Substances listed: PYRIDOXAL PHOSPHATE ANHYDROUS, POTASSIUM IODIDE, ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE

Package NDC codes

85477-322-30

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.