PRENATE DHA
- Product NDC
- 75854-312
- 11-digit product format
- 758540312
- Labeler code
- 75854
- Product ID
- 75854-312_4f5ba9ba-851e-4387-e063-6294a90a6ac1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium formate, ferrous asparto glycinate, magnesium oxide and doconexent
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Avion Pharmaceuticals, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2014-06-05
- Substance
- .ALPHA.-TOCOPHEROL, DL-; ASCORBIC ACID; CALCIUM FORMATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS ASPARTO GLYCINATE; FOLIC ACID; MAGNESIUM OXIDE; PYRIDOXINE HYDROCHLORIDE
- Active strength
- 40; 90; 155; 400; 25; 300; 18; 1; 50; 26 [iU]/1; mg/1; mg/1; [iU]/1; ug/1; mg/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], 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PRENATE DHA
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| .ALPHA.-TOCOPHEROL, DL- | 40 [iU]/1 |
| ASCORBIC ACID | 90 mg/1 |
| CALCIUM FORMATE | 155 mg/1 |
| CHOLECALCIFEROL | 400 [iU]/1 |
| CYANOCOBALAMIN | 25 ug/1 |
| DOCONEXENT | 300 mg/1 |
| FERROUS ASPARTO GLYCINATE | 18 mg/1 |
| FOLIC ACID | 1 mg/1 |
| MAGNESIUM OXIDE | 50 mg/1 |
| PYRIDOXINE HYDROCHLORIDE | 26 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 7QWA1RIO01, PQ6CK8PD0R, NP3JD65NPY, 1C6V77QF41, P6YC3EG204, ZAD9OKH9JC, H7426RGB3L, 935E97BOY8, 3A3U0GI71G, 68Y4CF58BV |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75854-312-30 | PRENATE DHA | 30 in 1 BOTTLE | CAPSULE, GELATIN COATED | 30 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 75854-312-30 | EA - Each | 75854-312 | 86c0e4df-d250-4c90-af9a-54bcc50f3be7 | 1 | 2014-08-01 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 75854-312 | PRENATE DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, MAGNESIUM OXIDE AND DOCONEXENT) CAPSULE, GELATIN COATED [AVION PHARMACEUTICALS, LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240123_8f2eca71-9a82-4a19-9206-36a04b865fe1.zip |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 75854-312-30 | 75854031230 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-312-30) | 2014-06-05 | 0000-00-00 | No | No | Current |