Indications and uses
Prenatal and Postnatal prescriptive Folic Acid
Embriva
- Manufacturer
- Oncora Pharma, LLC
- Effective date
- 2025-08-12
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 21:40:24
Label at a glance#
ProductEmbriva
Active ingredientPYRIDOXAL PHOSPHATE ANHYDROUS, POTASSIUM IODIDE, ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE
Label structure7 sections
Dosage and administration
Usual adult dose is 1 tablet once or twice daily or as prescribed by a licensed practitioner.
Label contents#
Full prescribing information#
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
INDICATIONS AND USAGE
Prenatal and Postnatal prescriptive Folic Acid
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. |
PRECAUTIONS
Call your licensed medical practitioner about side effects.
DOSAGE AND ADMINISTRATION
Usual adult dose is 1 tablet once or twice daily or as prescribed by a licensed practitioner.
HOW SUPPLIED
Bottles of 30: 85477-0322-30
Storage
KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN.
PRINCIPAL DISPLAY PANEL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASCORBIC ACID Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CALCIUM CATION Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230427 |
| CHOLECALCIFEROL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85477-322-30 | Embriva | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 85477-322-30 | EA - Each | 85477-322 | a565e379-ec21-4560-8e46-f333dca5a20a | 1 | 2026-02-05 |
Products#
Every source-derived product name is available through these pages.
- Embriva
- ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDE
- PYRIDOXAL PHOSPHATE ANHYDROUS
- POTASSIUM IODIDE
- IODIDE ION
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- SILICON DIOXIDE
- ASCORBIC ACID
- CHOLECALCIFEROL
- THIAMINE
- THIAMINE ION
- FOLIC ACID
- METHYLCOBALAMIN
- CALCIUM CARBONATE
- CALCIUM CATION
- FERROUS GLUCONATE
- FERROUS CATION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85477-322 | 85477-322-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PYRIDOXAL PHOSPHATE ANHYDROUS | F06SGE49M6 | ACTIB |
| POTASSIUM IODIDE | 1C4QK22F9J | ACTIB |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| ASCORBIC ACID | PQ6CK8PD0R | ACTIB |
| CHOLECALCIFEROL | 1C6V77QF41 | ACTIB |
| THIAMINE | X66NSO3N35 | ACTIB |
| FOLIC ACID | 935E97BOY8 | ACTIB |
| METHYLCOBALAMIN | BR1SN1JS2W | ACTIB |
| CALCIUM CARBONATE | H0G9379FGK | ACTIM |
| FERROUS GLUCONATE | U1B11I423Z | ACTIM |
Source Document#
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.
| 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 | 85477-322-30 85477-322 85477032230 3c362de4-1eda-83be-e063-6394a90a10fc 3c362de4-1ed9-83be-e063-6394a90a10fc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.