Prenate Elite
PRENATE ELITE
Approved
Approval ID
9b79c950-4312-4a53-9e36-fb8e00b053df
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.
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, calcium formate, ferrous asparto glycinate, cyanocobalamin, biotin, potassium iodide, magnesium oxide, zinc oxide and cupric oxide
PRODUCT DETAILS
NDC Product Code75854-314
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateJanuary 7, 2021
Generic Name.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, calcium formate, ferrous asparto glycinate, cyanocobalamin, biotin, potassium iodide, magnesium oxide, zinc oxide and cupric oxide
INGREDIENTS (26)
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BIOTINActive
Quantity: 330 ug in 1 1
Code: 6SO6U10H04
Classification: ACTIB
POTASSIUM IODIDEActive
Quantity: 150 ug in 1 1
Code: 1C4QK22F9J
Classification: ACTIM
MAGNESIUM OXIDEActive
Quantity: 25 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIM
.BETA.-CAROTENEActive
Quantity: 2600 [iU] in 1 1
Code: 01YAE03M7J
Classification: ACTIB
ASCORBIC ACIDActive
Quantity: 75 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 600 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
THIAMINE MONONITRATEActive
Quantity: 3 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
RIBOFLAVINActive
Quantity: 3.5 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
NIACINAMIDEActive
Quantity: 21 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 21 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
FOLIC ACIDActive
Quantity: 400 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
5-METHYLTETRAHYDROFOLIC ACIDActive
Quantity: 600 ug in 1 1
Code: TYK22LML8F
Classification: ACTIM
CALCIUM FORMATEActive
Quantity: 155 mg in 1 1
Code: NP3JD65NPY
Classification: ACTIM
FERROUS ASPARTO GLYCINATEActive
Quantity: 20 mg in 1 1
Code: H7426RGB3L
Classification: ACTIM
CYANOCOBALAMINActive
Quantity: 13 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
ZINC OXIDEActive
Quantity: 15 mg in 1 1
Code: SOI2LOH54Z
Classification: ACTIM
CUPRIC OXIDEActive
Quantity: 1.5 mg in 1 1
Code: V1XJQ704R4
Classification: ACTIM
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 40 [iU] in 1 1
Code: WR1WPI7EW8
Classification: ACTIM