Prenate Elite
- Product NDC
- 75854-314
- 11-digit product format
- 758540314
- Labeler code
- 75854
- Product ID
- 75854-314_894ca429-22b4-4b42-b732-bdeb40bcfacd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, calcium formate, ferrous asparto glycinate, cyanocobalamin, biotin, potassium iodide, magnesium oxide, zinc oxide and cupric oxide
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Avion Pharmaceuticals, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2014-06-05
- Substance
- .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; 5-METHYLTETRAHYDROFOLIC ACID; ASCORBIC ACID; BIOTIN; CALCIUM FORMATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS ASPARTO GLYCINATE; FOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE
- Active strength
- 40; 2600; 600; 75; 330; 155; 600; 1.5; 13; 20; 400; 25; 21; 150; 21; 3.5; 3; 15 [iU]/1; [iU]/1; ug/1; mg/1; ug/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/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], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Prenate Elite
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| .ALPHA.-TOCOPHEROL ACETATE, DL- | 40 [iU]/1 |
| .BETA.-CAROTENE | 2600 [iU]/1 |
| 5-METHYLTETRAHYDROFOLIC ACID | 600 ug/1 |
| ASCORBIC ACID | 75 mg/1 |
| BIOTIN | 330 ug/1 |
| CALCIUM FORMATE | 155 mg/1 |
| CHOLECALCIFEROL | 600 [iU]/1 |
| CUPRIC OXIDE | 1.5 mg/1 |
| CYANOCOBALAMIN | 13 ug/1 |
| FERROUS ASPARTO GLYCINATE | 20 mg/1 |
| FOLIC ACID | 400 ug/1 |
| MAGNESIUM OXIDE | 25 mg/1 |
| NIACINAMIDE | 21 mg/1 |
| POTASSIUM IODIDE | 150 ug/1 |
| PYRIDOXINE HYDROCHLORIDE | 21 mg/1 |
| RIBOFLAVIN | 3.5 mg/1 |
| THIAMINE MONONITRATE | 3 mg/1 |
| ZINC OXIDE | 15 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | WR1WPI7EW8, TYK22LML8F, PQ6CK8PD0R, 6SO6U10H04, NP3JD65NPY, 1C6V77QF41, V1XJQ704R4, P6YC3EG204, H7426RGB3L, 935E97BOY8, 3A3U0GI71G, 25X51I8RD4, 1C4QK22F9J, 68Y4CF58BV, TLM2976OFR, 8K0I04919X, SOI2LOH54Z |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75854-314-30 | Prenate Elite | 30 in 1 BOTTLE | TABLET, COATED | 30 | 6 |
DailyMed Billing Units#
| 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 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 75854-314 | PRENATE ELITE (.BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, 5-METHYLTETRAHYDROFOLIC ACID, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, CYANOCOBALAMIN, BIOTIN, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE AND CUPRIC OXIDE) TABLET, COATED [AVION PHARMACEUTICALS, LLC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20240124_9b79c950-4312-4a53-9e36-fb8e00b053df.zip |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 75854-314-30 | 75854031430 | 30 TABLET, COATED in 1 BOTTLE (75854-314-30) | 2014-06-05 | 0000-00-00 | No | No | Current |