healthy mamaBE WELL ROUNDED
healthy mama PRENATAL VITAMINS
Approved
Approval ID
b0addefd-148c-423b-bcff-332c255a2d90
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 9, 2013
Manufacturers
FDA
MATERNAL SCIENCE, LLC
DUNS: 078722406
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, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS BISGLYCINATE, ZINC OXIDE, COPPER, CALCIUM PANTOTHENATE,MAGNESIUM OXIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58154-107
Product Classification
G
Generic Name
.BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS BISGLYCINATE, ZINC OXIDE, COPPER, CALCIUM PANTOTHENATE,MAGNESIUM OXIDE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 9, 2013
FDA Product Classification
INGREDIENTS (39)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
.BETA.-CAROTENEActive
Quantity: 4000 [iU] in 1 1
Code: 01YAE03M7J
Classification: ACTIB
ASCORBIC ACIDActive
Quantity: 120 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 400 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
THIAMINEActive
Quantity: 1.8 mg in 1 1
Code: X66NSO3N35
Classification: ACTIB
RIBOFLAVINActive
Quantity: 1.7 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
NIACINActive
Quantity: 20 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 2.6 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
FOLIC ACIDActive
Quantity: 800 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
METHYLCOBALAMINActive
Quantity: 8 ug in 1 1
Code: BR1SN1JS2W
Classification: ACTIB
CALCIUM CARBONATEActive
Quantity: 200 mg in 1 1
Code: H0G9379FGK
Classification: ACTIM
FERROUS BISGLYCINATEActive
Quantity: 28 mg in 1 1
Code: SFW1D987QV
Classification: ACTIM
ZINC OXIDEActive
Quantity: 25 mg in 1 1
Code: SOI2LOH54Z
Classification: ACTIM
COPPERActive
Quantity: 2 mg in 1 1
Code: 789U1901C5
Classification: ACTIB
ASCORBYL PALMITATEInactive
Code: QN83US2B0N
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YI
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
BIOTINActive
Quantity: 30 ug in 1 1
Code: 6SO6U10H04
Classification: ACTIB
CALCIUM PANTOTHENATEActive
Quantity: 10 mg in 1 1
Code: 568ET80C3D
Classification: ACTIM
MAGNESIUM OXIDEActive
Quantity: 30 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 30 [iU] in 1 1
Code: WR1WPI7EW8
Classification: ACTIM