Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Avion Pharmaceuticals, LLC
Avion Pharmaceuticals, LLC
040348516
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PRENATE Restore
Product Details
NDC Product Code
75854-308Route of Administration
ORALEffective Date
January 7, 2021GELATINInactive
Code: 2G86QN327LClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
WHITE WAXInactive
Code: 7G1J5DA97FClass: IACT
CORN OILInactive
Code: 8470G57WFMClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 85 mg in 1 1
Vitamin D3Active
Code: 1C6V77QF41Class: ACTIBQuantity: 1000 [iU] in 1 1
Folic acidActive
Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1
PyridoxineActive
Code: 68Y4CF58BVClass: ACTIBQuantity: 25 mg in 1 1
Vitamin B12Active
Code: P6YC3EG204Class: ACTIBQuantity: 12 ug in 1 1
Calcium carbonateActive
Code: H0G9379FGKClass: ACTIMQuantity: 155 mg in 1 1
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 500 ug in 1 1
Ferrous fumarateActive
Code: R5L488RY0QClass: ACTIMQuantity: 27 mg in 1 1
Magnesium oxideActive
Code: 3A3U0GI71GClass: ACTIBQuantity: 45 mg in 1 1
Lactic acidActive
Code: 33X04XA5ATClass: ACTIBQuantity: 10 mg in 1 1
DoconexentActive
Code: ZAD9OKH9JCClass: ACTIBQuantity: 400 mg in 1 1
Code: WR1WPI7EW8Class: ACTIMQuantity: 10 [iU] in 1 1