Prenate Mini
Prenate Mini 75854-0315-30
Approved
Approval ID
8ab766c2-d554-4141-92b2-fbe038e80c9f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 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-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous asparto glycinate, iron, potassium iodide, magnesium oxide, doconexent and lowbush blueberry
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75854-315
Product Classification
G
Generic Name
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous asparto glycinate, iron, potassium iodide, magnesium oxide, doconexent and lowbush blueberry
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 7, 2021
FDA Product Classification
INGREDIENTS (25)
BIOTINActive
Quantity: 280 ug in 1 1
Code: 6SO6U10H04
Classification: ACTIB
CALCIUM CARBONATEActive
Quantity: 80 mg in 1 1
Code: H0G9379FGK
Classification: ACTIM
FERROUS ASPARTO GLYCINATEActive
Quantity: 9 mg in 1 1
Code: H7426RGB3L
Classification: ACTIM
IRONActive
Quantity: 9 mg in 1 1
Code: E1UOL152H7
Classification: ACTIM
POTASSIUM IODIDEActive
Quantity: 150 ug in 1 1
Code: 1C4QK22F9J
Classification: ACTIM
MAGNESIUM OXIDEActive
Quantity: 25 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIM
DOCONEXENTActive
Quantity: 350 mg in 1 1
Code: ZAD9OKH9JC
Classification: ACTIB
LOWBUSH BLUEBERRYActive
Quantity: 25 mg in 1 1
Code: G90PX41VP0
Classification: ACTIB
LEVOMEFOLIC ACIDActive
Quantity: 600 ug in 1 1
Code: 8S95DH25XC
Classification: ACTIB
FISH OILInactive
Code: XGF7L72M0F
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
ASCORBIC ACIDActive
Quantity: 60 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 1000 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 26 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
FOLIC ACIDActive
Quantity: 400 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 13 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 10 [iU] in 1 1
Code: WR1WPI7EW8
Classification: ACTIM