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 table
IngredientStrength
.ALPHA.-TOCOPHEROL10 [iU]/1
ASCORBIC ACID85 mg/1
BIOTIN250 ug/1
CALCIUM CARBONATE140 mg/1
CHOLECALCIFEROL200 [iU]/1
CYANOCOBALAMIN12 ug/1
DOCONEXENT300 mg/1
FERROUS FUMARATE28 mg/1
FOLIC ACID1 mg/1
ICOSAPENT40 mg/1
MAGNESIUM OXIDE45 mg/1
POTASSIUM IODIDE150 ug/1
PYRIDOXINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH4N855PNZ1, PQ6CK8PD0R, 6SO6U10H04, H0G9379FGK, 1C6V77QF41, P6YC3EG204, ZAD9OKH9JC, R5L488RY0Q, 935E97BOY8, AAN7QOV9EA, 3A3U0GI71G, 1C4QK22F9J, KV2JZ1BI6Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42192-332-30PNV-Omega30 in 1 BOTTLECAPSULE, GELATIN COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-332PNV-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]4Current NDC, Legacy NDC, 1 package rows20240116_735c5531-137f-4cee-8c68-ae121045a8ff.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42192-332-304219203323030 CAPSULE, GELATIN COATED in 1 BOTTLE (42192-332-30) 2010-08-190000-00-00NoNoCurrent