Prometa
Prometa & Prenatryl
Approved
Approval ID
b364551b-2ccc-4db3-e053-2995a90afbbf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 8, 2023
Manufacturers
FDA
PureTek Corporation
DUNS: 785961046
Products 2
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59088-169
Product Classification
G
Generic Name
Ferrous Fumarate, Folic Acid
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2023
FDA Product Classification
INGREDIENTS (28)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MAGNESIUM OXIDEActive
Quantity: 200 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIB
SELENIUMActive
Quantity: 70 ug in 1 1
Code: H6241UJ22B
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYDROXYMETHYL CELLULOSEInactive
Code: 273FM27VK1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANGANESE SULFATEActive
Quantity: 2.6 mg in 1 1
Code: W00LYS4T26
Classification: ACTIM
VITAMIN A ACETATEActive
Quantity: 1500 ug in 1 1
Code: 3LE3D9D6OY
Classification: ACTIM
ASCORBIC ACIDActive
Quantity: 120 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 20 ug in 1 1
Code: 1C6V77QF41
Classification: ACTIB
THIAMINE MONONITRATEActive
Quantity: 3 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
RIBOFLAVINActive
Quantity: 3.4 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
NIACINAMIDEActive
Quantity: 20 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIM
FOLIC ACIDActive
Quantity: 1000 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 10 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
CALCIUM CARBONATEActive
Quantity: 200 mg in 1 1
Code: H0G9379FGK
Classification: ACTIM
FERROUS FUMARATEActive
Quantity: 27 mg in 1 1
Code: R5L488RY0Q
Classification: ACTIM
ZINC OXIDEActive
Quantity: 25 mg in 1 1
Code: SOI2LOH54Z
Classification: ACTIM
MOLYBDENUMActive
Quantity: 50 ug in 1 1
Code: 81AH48963U
Classification: ACTIB
CHOLINE BITARTRATEActive
Quantity: 55 mg in 1 1
Code: 6K2W7T9V6Y
Classification: ACTIM
CHROMIUM NICOTINATEActive
Quantity: 45 ug in 1 1
Code: A150AY412V
Classification: ACTIB
POTASSIUM IODIDEActive
Quantity: 150 ug in 1 1
Code: 1C4QK22F9J
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 30 mg in 1 1
Code: WR1WPI7EW8
Classification: ACTIM
Ferrous Fumarate, Folic Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59088-172
Product Classification
G
Generic Name
Ferrous Fumarate, Folic Acid
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2023
FDA Product Classification
INGREDIENTS (28)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
MAGNESIUM OXIDEActive
Quantity: 200 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIB
HYDROXYMETHYL CELLULOSEInactive
Code: 273FM27VK1
Classification: IACT
MANGANESE SULFATEActive
Quantity: 2.6 mg in 1 1
Code: W00LYS4T26
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
VITAMIN A ACETATEActive
Quantity: 1500 ug in 1 1
Code: 3LE3D9D6OY
Classification: ACTIM
ASCORBIC ACIDActive
Quantity: 120 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
THIAMINE MONONITRATEActive
Quantity: 3 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
RIBOFLAVINActive
Quantity: 3.4 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 20 ug in 1 1
Code: 1C6V77QF41
Classification: ACTIB
NIACINAMIDEActive
Quantity: 20 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIM
CYANOCOBALAMINActive
Quantity: 10 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
FOLIC ACIDActive
Quantity: 1000 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
CALCIUM CARBONATEActive
Quantity: 200 mg in 1 1
Code: H0G9379FGK
Classification: ACTIM
FERROUS FUMARATEActive
Quantity: 27 mg in 1 1
Code: R5L488RY0Q
Classification: ACTIM
ZINC OXIDEActive
Quantity: 25 mg in 1 1
Code: SOI2LOH54Z
Classification: ACTIM
MOLYBDENUMActive
Quantity: 50 ug in 1 1
Code: 81AH48963U
Classification: ACTIB
SELENIUMActive
Quantity: 70 ug in 1 1
Code: H6241UJ22B
Classification: ACTIB
CHOLINE BITARTRATEActive
Quantity: 55 mg in 1 1
Code: 6K2W7T9V6Y
Classification: ACTIM
CHROMIUM NICOTINATEActive
Quantity: 45 ug in 1 1
Code: A150AY412V
Classification: ACTIB
POTASSIUM IODIDEActive
Quantity: 150 ug in 1 1
Code: 1C4QK22F9J
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 30 mg in 1 1
Code: WR1WPI7EW8
Classification: ACTIM