MedPath

BP Vit 3

BP Vit 3 CapsulesRx Only

Approved
Approval ID

8bf7a233-1813-4989-8886-fe7257a16054

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 11, 2023

Manufacturers
FDA

Acella Pharmaceuticals, LLC

DUNS: 825380939

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

folic acid, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent and .beta.-sitosterol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42192-301
Product Classification
G
Generic Name
folic acid, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent and .beta.-sitosterol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification

INGREDIENTS (17)

PYRIDOXINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
FOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 500 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
OMEGA-3 FATTY ACIDSActive
Quantity: 500 mg in 1 1
Code: 71M78END5S
Classification: ACTIB
ICOSAPENTActive
Quantity: 35 mg in 1 1
Code: AAN7QOV9EA
Classification: ACTIB
DOCONEXENTActive
Quantity: 350 mg in 1 1
Code: ZAD9OKH9JC
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ASCORBYL PALMITATEInactive
Code: QN83US2B0N
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
.BETA.-SITOSTEROLActive
Quantity: 200 mg in 1 1
Code: S347WMO6M4
Classification: ACTIB

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BP Vit 3 - FDA Drug Approval Details