Home NDC 42192-332 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ASCORBIC ACID 10 [iU]/1 CHOLECALCIFEROL 85 mg/1 .ALPHA.-TOCOPHEROL 250 ug/1 PYRIDOXINE 140 mg/1 FOLIC ACID 200 [iU]/1 CYANOCOBALAMIN 12 ug/1 BIOTIN 300 mg/1 CALCIUM CARBONATE 28 mg/1 FERROUS FUMARATE 1 mg/1 POTASSIUM IODIDE 40 mg/1 MAGNESIUM OXIDE 45 mg/1 DOCONEXENT 150 ug/1 ICOSAPENT 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 13 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42192-332-30 PNV-Omega 30 in 1 BOTTLE CAPSULE, GELATIN COATED 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table 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
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PNV-Omega ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENT Acella Pharmaceuticals, LLC 735c5531-137f-4cee-8c68-ae121045a8ff 2026-07-22 Boxed warning, Warnings, Adverse reactions Exact identifier ndc (product): 42192-332
Packages# Package NDC, 11-digit format, Description table 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