PNV-DHA
PNV-DHA + DOCUSATE
Approved
Approval ID
576e8bbb-1625-493c-85da-43caf2f02e3c
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 acetate, dl-, pyridoxine, folic acid, calcium, ferrous fumarate, doconexent
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42192-323
Product Classification
G
Generic Name
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, calcium, ferrous fumarate, doconexent
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 11, 2018
FDA Product Classification
INGREDIENTS (20)
GELATIN TYPE B BOVINE (230 BLOOM)Inactive
Code: WIL1404U79
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
ETHYL VANILLINInactive
Code: YC9ST449YJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ASCORBIC ACIDActive
Quantity: 28 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
CALCIUMActive
Quantity: 160 mg in 1 1
Code: SY7Q814VUP
Classification: ACTIB
FERROUS FUMARATEActive
Quantity: 27 mg in 1 1
Code: R5L488RY0Q
Classification: ACTIM
CHOLECALCIFEROLActive
Quantity: 400 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
PYRIDOXINEActive
Quantity: 25 mg in 1 1
Code: KV2JZ1BI6Z
Classification: ACTIB
FOLIC ACIDActive
Quantity: 1.25 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
DOCONEXENTActive
Quantity: 300 mg in 1 1
Code: ZAD9OKH9JC
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 30 [iU] in 1 1
Code: WR1WPI7EW8
Classification: ACTIM