MedPath

Prenate Chewable

chewable

Approved
Approval ID

917f02ce-51b9-4819-81e0-522842f6732a

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.

calcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin and bilberry

PRODUCT DETAILS

NDC Product Code75854-306
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateJanuary 7, 2021
Generic Namecalcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin and bilberry

INGREDIENTS (13)

FRUCTOSEInactive
Code: 6YSS42VSEV
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CALCIUM CARBONATEActive
Quantity: 500 mg in 1 1
Code: H0G9379FGK
Classification: ACTIM
CHOLECALCIFEROLActive
Quantity: 300 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
FOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
MAGNESIUM OXIDEActive
Quantity: 50 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIB
BORONActive
Quantity: 250 ug in 1 1
Code: N9E3X5056Q
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 125 mg in 1 1
Code: P6YC3EG204
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
BIOTINActive
Quantity: 280 ug in 1 1
Code: 6SO6U10H04
Classification: ACTIB
BILBERRYActive
Quantity: 25 mg in 1 1
Code: 9P2U39H18W
Classification: ACTIB
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Prenate Chewable - FDA Approval | MedPath