PNV-Omega
- Product NDC
- 42192-332
- 11-digit product format
- 421920332
- Labeler code
- 42192
- Product ID
- 42192-332_f14fe675-b4a7-4c9c-ad3c-d97054ff4770
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, folic acid, cyanocobalamin, calcium corbonate, ferrous fumarate, potassium iodide, magnesium, doconexent, icosapent
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Acella Pharmaceuticals, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2010-08-19
- Substance
- .ALPHA.-TOCOPHEROL; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; ICOSAPENT; MAGNESIUM OXIDE; POTASSIUM IODIDE; PYRIDOXINE
- Active strength
- 10; 85; 250; 140; 200; 12; 300; 28; 1; 40; 45; 150; 25 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PNV-Omega
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| .ALPHA.-TOCOPHEROL | 10 [iU]/1 |
| ASCORBIC ACID | 85 mg/1 |
| BIOTIN | 250 ug/1 |
| CALCIUM CARBONATE | 140 mg/1 |
| CHOLECALCIFEROL | 200 [iU]/1 |
| CYANOCOBALAMIN | 12 ug/1 |
| DOCONEXENT | 300 mg/1 |
| FERROUS FUMARATE | 28 mg/1 |
| FOLIC ACID | 1 mg/1 |
| ICOSAPENT | 40 mg/1 |
| MAGNESIUM OXIDE | 45 mg/1 |
| POTASSIUM IODIDE | 150 ug/1 |
| PYRIDOXINE | 25 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | H4N855PNZ1, PQ6CK8PD0R, 6SO6U10H04, H0G9379FGK, 1C6V77QF41, P6YC3EG204, ZAD9OKH9JC, R5L488RY0Q, 935E97BOY8, AAN7QOV9EA, 3A3U0GI71G, 1C4QK22F9J, KV2JZ1BI6Z |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42192-332-30 | PNV-Omega | 30 in 1 BOTTLE | CAPSULE, GELATIN COATED | 30 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42192-332-30 | EA - Each | 42192-332 | 71029eae-ed35-47e0-a0c6-ff5713151e21 | 1 | 2018-02-20 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 42192-332 | PNV-OMEGA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240116_735c5531-137f-4cee-8c68-ae121045a8ff.zip |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42192-332-30 | 42192033230 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (42192-332-30) | 2010-08-19 | 0000-00-00 | No | No | Current |