Ribotin-E
Ribotin-E™
Approved
Approval ID
bb1492c5-bfcd-d632-e053-2a95a90ad7d1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2023
Manufacturers
FDA
PureTek Corporation
DUNS: 785961046
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ferrous Fumarate, Folic Acid
PRODUCT DETAILS
NDC Product Code59088-182
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateJanuary 11, 2023
Generic NameFerrous Fumarate, Folic Acid
INGREDIENTS (34)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
ICODEXTRINInactive
Code: 2NX48Z0A9G
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
VITAMIN A ACETATEActive
Quantity: 1500 ug in 1 1
Code: 3LE3D9D6OY
Classification: ACTIM
ASCORBIC ACIDActive
Quantity: 250 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
RIBOFLAVINActive
Quantity: 3.35 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
FOLIC ACIDActive
Quantity: 500 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
THIAMINE MONONITRATEActive
Quantity: 3.25 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
NIACINAMIDEActive
Quantity: 22.5 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 6 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIM
POTASSIUM IODIDEActive
Quantity: 25 ug in 1 1
Code: 1C4QK22F9J
Classification: ACTIM
CALCIUM CARBONATEActive
Quantity: 75 mg in 1 1
Code: H0G9379FGK
Classification: ACTIM
ZINC OXIDEActive
Quantity: 15 mg in 1 1
Code: SOI2LOH54Z
Classification: ACTIM
MAGNESIUM OXIDEActive
Quantity: 37.5 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIM
CUPROUS OXIDEActive
Quantity: 1 mg in 1 1
Code: T8BEA5064F
Classification: ACTIB
CHROMIUM NICOTINATEActive
Quantity: 37.5 ug in 1 1
Code: A150AY412V
Classification: ACTIB
SELENIUMActive
Quantity: 30 ug in 1 1
Code: H6241UJ22B
Classification: ACTIB
BORONActive
Quantity: 25 ug in 1 1
Code: N9E3X5056Q
Classification: ACTIB
MANGANESE SULFATEActive
Quantity: 0.75 mg in 1 1
Code: W00LYS4T26
Classification: ACTIM
MOLYBDENUMActive
Quantity: 25 ug in 1 1
Code: 81AH48963U
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 24.5 mg in 1 1
Code: 660YQ98I10
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CHOLECALCIFEROLActive
Quantity: 13.75 ug in 1 1
Code: 1C6V77QF41
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 13 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
BIOTINActive
Quantity: 100 ug in 1 1
Code: 6SO6U10H04
Classification: ACTIB
PANTOTHENIC ACIDActive
Quantity: 15 mg in 1 1
Code: 19F5HK2737
Classification: ACTIB
FERROUS FUMARATEActive
Quantity: 9 mg in 1 1
Code: R5L488RY0Q
Classification: ACTIM
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 45 mg in 1 1
Code: WR1WPI7EW8
Classification: ACTIM
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 7/13/2021
Chronocap
