Prenyra
- Manufacturer
- Oncora Pharma, LLC | Solubiomix
- Effective date
- 2026-05-08
- Label type
- DIETARY SUPPLEMENT
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:52:55
Label at a glance#
Label contents#
Full prescribing information#
Description
Prenyra Tablets is an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nutritional status
in patients where advanced folate supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.
Warnings
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.
CONTRAINDICATIONS: Prenyra Tablets are contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.
Precaution
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Prenyra Tablets should only be used under the direction and supervision of a licensed medical practitioner.
For external use only
Dosage & Administration
Usual adult dose is 1 tablet taken orally once or twice daily or as prescribed by a licensed medical practitioner.
STORAGE: Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Protect from heat, light and moisture.
Tamper Evident: Do not use if seal is broken or missing.
Manufacturered for:
Oncora Pharma LLC
Dallas TX 75228
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 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0854770923300 | GTIN-13: 0854770923300 EAN-13: 0854770923300 GTIN-12: 854770923300 UPC-A: 854770923300 GTIN storage (14 digits): 00854770923300 | prenyra-2.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85477-923-30 | Prenyra | 30 in 1 BOTTLE | TABLET | 30 | 2 |
Products#
Every source-derived product name is available through these pages.
- Prenyra
- ASCORBIC ACID
- CHOLECALCIFEROL
- THIAMINE HYDROCHLORIDE
- Thiamine ION
- PYRIDOXAL 5-PHOSPHATE
- IODIDE ION
- FOLIC ACID
- METHYLCOBALAMIN
- FERROUS GLUCONATE
- FERROUS CATION
- CALCIUM CARBONATE
- CALCIUM CATION
- CELLULOSE, MICROCRYSTALLINE
- MAGNESIUM STEARATE
- SILICA
- GLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85477-923 | 85477-923-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASCORBIC ACID | PQ6CK8PD0R | ACTIB |
| CHOLECALCIFEROL | 1C6V77QF41 | ACTIB |
| THIAMINE HYDROCHLORIDE | M572600E5P | ACTIB |
| PYRIDOXAL 5-PHOSPHATE | F06SGE49M6 | ACTIB |
| IODIDE ION | 09G4I6V86Q | ACTIB |
| FOLIC ACID | 935E97BOY8 | ACTIB |
| METHYLCOBALAMIN | BR1SN1JS2W | ACTIB |
| FERROUS GLUCONATE | U1B11I423Z | ACTIM |
| CALCIUM CARBONATE | H0G9379FGK | ACTIB |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SILICA | ETJ7Z6XBU4 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
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 |
|---|---|---|---|---|---|---|
| Ascorbic Acid | ASCORBIC ACID | Renova Pharmaceuticals LLC | a6481bae-2397-44c7-a51d-4f47ad91bd2c | 2026-08-19 | Warnings, Adverse reactions | ASCORBIC ACID |
| Ascor | ASCORBIC ACID | McGuff Pharmaceuticals, Inc. | 388aad52-fc01-4784-9791-1dbc80c69306 | 2026-05-29 | Warnings, Adverse reactions | ASCORBIC ACID |
| Ascorbic Acid | ASCORBIC ACID | Fresenius Kabi USA, LLC | 1606e29f-0e80-4069-b688-daab9cbff20a | 2025-12-17 | Warnings, Adverse reactions | ASCORBIC ACID |
| Skin Renewing Serum | ASCORBIC ACID | Guangzhou Danting Bath&Body Care Industry Co. Ltd | 396c2a8d-ac95-cbef-e063-6294a90aff39 | 2025-08-23 | Warnings | ASCORBIC ACID |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

