MYNEPHROCAPS
Approved
Approval ID
ef0391c1-bbd8-400d-a8ab-add565df2d6c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2013
Manufacturers
FDA
MARTIN EKWEALOR PHARMACEUTICALS, INC.
DUNS: 624528386
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ASCORBIC ACID, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CALCIUM PANTOTHENATE, THIAMINE MONONITRATE, FOLIC ACID, BIOTIN, CYANOCOBALAMIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58607-186
Product Classification
G
Generic Name
ASCORBIC ACID, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CALCIUM PANTOTHENATE, THIAMINE MONONITRATE, FOLIC ACID, BIOTIN, CYANOCOBALAMIN
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2013
FDA Product Classification
INGREDIENTS (19)
CYANOCOBALAMINActive
Quantity: 6 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
ASCORBIC ACIDActive
Quantity: 100 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
NIACINAMIDEActive
Quantity: 20 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIM
RIBOFLAVINActive
Quantity: 1.7 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
CALCIUM PANTOTHENATEActive
Quantity: 5 mg in 1 1
Code: 568ET80C3D
Classification: ACTIM
FOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
BIOTINActive
Quantity: 150 ug in 1 1
Code: 6SO6U10H04
Classification: ACTIB
THIAMINE MONONITRATEActive
Quantity: 1.5 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT