PRENATE Restore
Restore
Approved
Approval ID
1076ba9a-0168-492f-ba9b-99fa02186092
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2024
Manufacturers
FDA
Avion Pharmaceuticals, LLC
DUNS: 040348516
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-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75854-308
Product Classification
G
Generic Name
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 7, 2021
FDA Product Classification
INGREDIENTS (21)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
ASCORBIC ACIDActive
Quantity: 85 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 1000 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
FOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 12 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
CALCIUM CARBONATEActive
Quantity: 155 mg in 1 1
Code: H0G9379FGK
Classification: ACTIM
BIOTINActive
Quantity: 500 ug in 1 1
Code: 6SO6U10H04
Classification: ACTIB
FERROUS FUMARATEActive
Quantity: 27 mg in 1 1
Code: R5L488RY0Q
Classification: ACTIM
MAGNESIUM OXIDEActive
Quantity: 45 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIB
LACTIC ACIDActive
Quantity: 10 mg in 1 1
Code: 33X04XA5AT
Classification: ACTIB
DOCONEXENTActive
Quantity: 400 mg in 1 1
Code: ZAD9OKH9JC
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 10 [iU] in 1 1
Code: WR1WPI7EW8
Classification: ACTIM