PNV-Omega
PNV - Omega
Approved
Approval ID
735c5531-137f-4cee-8c68-ae121045a8ff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2024
Manufacturers
FDA
Acella Pharmaceuticals, LLC
DUNS: 825380939
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, folic acid, cyanocobalamin, calcium corbonate, ferrous fumarate, potassium iodide, magnesium, doconexent, icosapent
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42192-332
Product Classification
G
Generic Name
ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, folic acid, cyanocobalamin, calcium corbonate, ferrous fumarate, potassium iodide, magnesium, doconexent, icosapent
Product Specifications
Route of AdministrationORAL
Effective DateJune 27, 2019
FDA Product Classification
INGREDIENTS (22)
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
.ALPHA.-TOCOPHEROLActive
Quantity: 10 [iU] in 1 1
Code: H4N855PNZ1
Classification: ACTIB
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
ASCORBIC ACIDActive
Quantity: 85 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 200 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
PYRIDOXINEActive
Quantity: 25 mg in 1 1
Code: KV2JZ1BI6Z
Classification: ACTIB
FOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 12 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
BIOTINActive
Quantity: 250 ug in 1 1
Code: 6SO6U10H04
Classification: ACTIB
CALCIUM CARBONATEActive
Quantity: 140 mg in 1 1
Code: H0G9379FGK
Classification: ACTIM
FERROUS FUMARATEActive
Quantity: 28 mg in 1 1
Code: R5L488RY0Q
Classification: ACTIM
DOCONEXENTActive
Quantity: 300 mg in 1 1
Code: ZAD9OKH9JC
Classification: ACTIB
POTASSIUM IODIDEActive
Quantity: 150 ug in 1 1
Code: 1C4QK22F9J
Classification: ACTIM
MAGNESIUM OXIDEActive
Quantity: 45 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIM
ICOSAPENTActive
Quantity: 40 mg in 1 1
Code: AAN7QOV9EA
Classification: ACTIB