PRENATE Restore
- Product NDC
- 75854-308
- 11-digit product format
- 758540308
- Labeler code
- 75854
- Product ID
- 75854-308_58c8617b-5f76-524f-e063-6294a90af1b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium, iron, magnesium oxide, lactic acid and doconexent
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Avion Pharmaceuticals, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2013-09-17
- Substance
- ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM; IRON; MAGNESIUM OXIDE; LACTIC ACID; DOCONEXENT
- Active strength
- 85; 1000; 10; 1; 25; 12; 500; 160; 27; 45; 10; 400 mg/1; [iU]/1; [iU]/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Acidifying Activity [MoA], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Calculi Dissolution Agent [EPC], 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], 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 Restore
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ASCORBIC ACID | 85 mg/1 |
| CHOLECALCIFEROL | 1000 [iU]/1 |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | 10 [iU]/1 |
| FOLIC ACID | 1 mg/1 |
| PYRIDOXINE HYDROCHLORIDE | 25 mg/1 |
| CYANOCOBALAMIN | 12 ug/1 |
| BIOTIN | 500 ug/1 |
| CALCIUM | 160 mg/1 |
| IRON | 27 mg/1 |
| MAGNESIUM OXIDE | 45 mg/1 |
| LACTIC ACID | 10 mg/1 |
| DOCONEXENT | 400 mg/1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75854-308-30 | PRENATE Restore | 30 in 1 BOTTLE | CAPSULE, GELATIN COATED | 30 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 75854-308-30 | EA - Each | 75854-308 | 7b9f2919-714f-41a6-a79e-3902292bf6a7 | 1 | 2013-10-17 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 75854-308 | PRENATE RESTORE (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENT) CAPSULE, GELATIN COATED [AVION PHARMACEUTICALS, LLC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20240123_1076ba9a-0168-492f-ba9b-99fa02186092.zip |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 75854-308-30 | 75854030830 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-308-30) | 2013-09-17 | 0000-00-00 | No | No | Current |