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.
Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
Rx Only Dietary Supplement
DESCRIPTION: PRENATE ELITE ® is a white, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with “PN” on one side and blank on the other. Contains no ingredient made from gluten-containing grain (wheat, barley, or rye).
OTHER INGREDIENTS: Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid. Film Coating (Hypromellose, Titanium Dioxide,Triacetin).
INDICATIONS: PRENATE ELITE ® is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.
CONTRAINDICATIONS: PRENATE ELITE ® is contraindicated in patients with a known hypersensitivity to any of the ingredients.
PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic test (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.
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: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one tablet daily or as directed by a physician.
HOW SUPPLIED: Bottles of 30 tablets (75854-314-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.
Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Alpharetta, Georgia 30005
1-888-61-AVION
L-0307 Rev. 0325-03
Formical ® is a registered trademark of Nephro-Tech 1, LLC, covered by one or more claims of U.S. Patent No. 6,528,542.
Sumalate ® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 5,516,925, 6,716,814, 8,007,846, and 8,425,956.
PRENATE ® is a registered trademark of Avion Pharmaceuticals, LLC. All rights reserved.
THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
75854-314-30
Prenate Elite
®
PRENATAL VITAMINS-FILM-COATED TABLETS
GLUTEN FREE
Rx Only
Dietary Supplement
30 Tablets
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0375854314307 | GTIN-13: 0375854314307 EAN-13: 0375854314307 GTIN-12: 375854314307 UPC-A: 375854314307 GTIN storage (14 digits): 00375854314307 | Prenate Elite BL L-0307 Rev. 0325-03.jpg |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 75854-314-30 | EA - Each | 75854-314 | 9eb8027a-46b7-4748-9d62-1feeebca766d | 1 | 2014-08-01 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .ALPHA.-TOCOPHEROL ACETATE, DL- | ACTIVE INGREDIENT | WR1WPI7EW8 | 1 | |
| .BETA.-CAROTENE | ACTIVE INGREDIENT | 01YAE03M7J | 1 | |
| 5-METHYLTETRAHYDROFOLIC ACID | ACTIVE INGREDIENT | TYK22LML8F | 1 | |
| ASCORBIC ACID | ACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| BIOTIN | ACTIVE INGREDIENT | 6SO6U10H04 | 1 | |
| CALCIUM FORMATE | ACTIVE INGREDIENT | NP3JD65NPY | 1 | |
| CHOLECALCIFEROL | ACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| CUPRIC OXIDE | ACTIVE INGREDIENT | V1XJQ704R4 | 1 | |
| CYANOCOBALAMIN | ACTIVE INGREDIENT | P6YC3EG204 | 1 | |
| FERROUS ASPARTO GLYCINATE | ACTIVE INGREDIENT | H7426RGB3L | 1 | |
| FOLIC ACID | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| MAGNESIUM OXIDE | ACTIVE INGREDIENT | 3A3U0GI71G | 1 | |
| NIACINAMIDE | ACTIVE INGREDIENT | 25X51I8RD4 | 1 | |
| POTASSIUM IODIDE | ACTIVE INGREDIENT | 1C4QK22F9J | 1 | |
| PYRIDOXINE HYDROCHLORIDE | ACTIVE INGREDIENT | 68Y4CF58BV | 1 | |
| RIBOFLAVIN | ACTIVE INGREDIENT | TLM2976OFR | 1 | |
| THIAMINE MONONITRATE | ACTIVE INGREDIENT | 8K0I04919X | 1 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| .ALPHA.-TOCOPHEROL, DL- | ACTIVE MOIETY | 7QWA1RIO01 | 1 | |
| .BETA.-CAROTENE | ACTIVE MOIETY | 01YAE03M7J | 1 | |
| 5-METHYLTETRAHYDROFOLIC ACID | ACTIVE MOIETY | TYK22LML8F | 1 | |
| ASCORBIC ACID | ACTIVE MOIETY | PQ6CK8PD0R | 1 | |
| BIOTIN | ACTIVE MOIETY | 6SO6U10H04 | 1 | |
| CALCIUM CATION | ACTIVE MOIETY | 2M83C4R6ZB | 1 | |
| CHOLECALCIFEROL | ACTIVE MOIETY | 1C6V77QF41 | 1 | |
| CUPRIC CATION | ACTIVE MOIETY | 8CBV67279L | 1 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | 1 | |
| FERROUS CATION | ACTIVE MOIETY | GW89581OWR | 1 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| IODIDE ION | ACTIVE MOIETY | 09G4I6V86Q | 1 | |
| MAGNESIUM CATION | ACTIVE MOIETY | T6V3LHY838 | 1 | |
| NIACINAMIDE | ACTIVE MOIETY | 25X51I8RD4 | 1 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| RIBOFLAVIN | ACTIVE MOIETY | TLM2976OFR | 1 | |
| THIAMINE ION | ACTIVE MOIETY | 4ABT0J945J | 1 | |
| ZINC CATION | ACTIVE MOIETY | 13S1S8SF37 | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POWDERED CELLULOSE | INACTIVE INGREDIENT | SMD1X3XO9M | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 75854-314 | 75854-314-30 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 8 | 2026-06-12 | monthly-update | 2026-07-17 21:39:18 |
| 7 | 2026-06-09 | daily-update | 2026-06-11 05:11:51 |
| 6 | 2024-01-23 | full-release | 2026-05-31 20:58:40 |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | TABLET, COATED / ORAL | 40.2 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, COATED / ORAL | 224 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | TABLET, COATED / ORAL | 40.2 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, COATED / ORAL | 1 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, COATED / ORAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, COATED / ORAL | 224 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg |
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 |
|---|---|---|---|---|---|---|
| Prenate Elite | .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 | Avion Pharmaceuticals, LLC | 9b79c950-4312-4a53-9e36-fb8e00b053df | 2026-06-12 | Boxed warning, Adverse reactions | 75854-314-30 75854-314 75854031430 9b79c950-4312-4a53-9e36-fb8e00b053df |
Adverse event summaries are temporarily unavailable. Other product information remains available.