Prenate Essential
- Product NDC
- 75854-313
- 11-digit product format
- 758540313
- Labeler code
- 75854
- Product ID
- 75854-313_5413d54f-f790-2d5c-e063-6294a90a7460
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, levomefolate calcium, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Avion Pharmaceuticals, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2014-07-18
- Substance
- ICOSAPENT; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM; CYANOCOBALAMIN; BIOTIN; CALCIUM FORMATE; FERROUS ASPARTO GLYCINATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT
- Active strength
- 40; 90; 5.5; 4.5; 26; 400; 600; 13; 280; 160; 18; 150; 50; 300 mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1
- Pharmacologic classes
- Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- Prenate Essential
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ICOSAPENT | 40 mg/1 |
| ASCORBIC ACID | 90 mg/1 |
| CHOLECALCIFEROL | 5.5 ug/1 |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | 4.5 mg/1 |
| PYRIDOXINE HYDROCHLORIDE | 26 mg/1 |
| FOLIC ACID | 400 ug/1 |
| LEVOMEFOLATE CALCIUM | 600 ug/1 |
| CYANOCOBALAMIN | 13 ug/1 |
| BIOTIN | 280 ug/1 |
| CALCIUM FORMATE | 160 mg/1 |
| FERROUS ASPARTO GLYCINATE | 18 mg/1 |
| POTASSIUM IODIDE | 150 ug/1 |
| MAGNESIUM OXIDE | 50 mg/1 |
| DOCONEXENT | 300 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| AAN7QOV9EA | Internal UNII lookup |
| PQ6CK8PD0R | Internal UNII lookup |
| 1C6V77QF41 | Internal UNII lookup |
| WR1WPI7EW8 | Internal UNII lookup |
| 68Y4CF58BV | Internal UNII lookup |
| 935E97BOY8 | Internal UNII lookup |
| A9R10K3F2F | Internal UNII lookup |
| P6YC3EG204 | Internal UNII lookup |
| 6SO6U10H04 | Internal UNII lookup |
| NP3JD65NPY | Internal UNII lookup |
| H7426RGB3L | Internal UNII lookup |
| 1C4QK22F9J | Internal UNII lookup |
| 3A3U0GI71G | Internal UNII lookup |
| ZAD9OKH9JC | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e5acfb2a-0959-4542-9b4c-790be194d581 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75854-313-30 | Prenate Essential | 30 in 1 BOTTLE | CAPSULE, GELATIN COATED | 30 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 75854-313-30 | EA - Each | 75854-313 | 600564cd-d37f-4b98-ac2b-894fb378145c | 1 | 2014-09-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 75854-313 | PRENATE ESSENTIAL (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, 5-METHYLTETRAHYDROFOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND ICOSAPENT) CAPSULE, GELATIN COATED [AVION PHARMACEUTICALS, LLC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20240124_e5acfb2a-0959-4542-9b4c-790be194d581.zip |
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 |
|---|---|---|---|---|---|---|
| Prenate Essential | ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, BIOTIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND ICOSAPENT | Avion Pharmaceuticals, LLC | e5acfb2a-0959-4542-9b4c-790be194d581 | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | 75854-313 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 75854-313-30 | 75854031330 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-313-30) | 2014-07-18 | 0000-00-00 | No | No | Current |