Quflora Pediatric
Quflora™ Pediatric Chewable Tablets
Approved
Approval ID
b8e08798-d8bb-4616-996b-a2c07a5d730a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
CarWin Pharmaceutical Associates, LLC
DUNS: 079217215
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15370-103
Product Classification
G
Generic Name
VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (22)
VITAMIN A ACETATEActive
Quantity: 1200 [iU] in 1 1
Code: 3LE3D9D6OY
Classification: ACTIM
ASCORBIC ACIDActive
Quantity: 60 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 400 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
NIACINAMIDEActive
Quantity: 5 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 1.5 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
MAGNESIUM OXIDEActive
Quantity: 15 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 4 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
CUPRIC SULFATEActive
Quantity: 1 mg in 1 1
Code: LRX7AJ16DT
Classification: ACTIM
SODIUM FLUORIDEActive
Quantity: 0.25 mg in 1 1
Code: 8ZYQ1474W7
Classification: ACTIM
GRAPEInactive
Code: 6X543N684K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
THIAMINE HYDROCHLORIDEActive
Quantity: 1.2 mg in 1 1
Code: M572600E5P
Classification: ACTIR
RIBOFLAVINActive
Quantity: 1.3 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
LEVOMEFOLIC ACIDActive
Quantity: 108 ug in 1 1
Code: 8S95DH25XC
Classification: ACTIB
FOLIC ACIDActive
Quantity: 100 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Active
Quantity: 15 [iU] in 1 1
Code: 7QWA1RIO01
Classification: ACTIB
VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15370-105
Product Classification
G
Generic Name
VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (22)
VITAMIN A ACETATEActive
Quantity: 1200 [iU] in 1 1
Code: 3LE3D9D6OY
Classification: ACTIM
CHOLECALCIFEROLActive
Quantity: 400 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
ASCORBIC ACIDActive
Quantity: 60 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
RIBOFLAVINActive
Quantity: 1.3 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
THIAMINE HYDROCHLORIDEActive
Quantity: 1.2 mg in 1 1
Code: M572600E5P
Classification: ACTIR
NIACINAMIDEActive
Quantity: 5 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
CUPRIC SULFATEActive
Quantity: 1 mg in 1 1
Code: LRX7AJ16DT
Classification: ACTIM
LEVOMEFOLIC ACIDActive
Quantity: 108 ug in 1 1
Code: 8S95DH25XC
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 4 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 1.5 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
FOLIC ACIDActive
Quantity: 100 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
MAGNESIUM OXIDEActive
Quantity: 15 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIB
SODIUM FLUORIDEActive
Quantity: 1 mg in 1 1
Code: 8ZYQ1474W7
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
GRAPEInactive
Code: 6X543N684K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Active
Quantity: 15 [iU] in 1 1
Code: 7QWA1RIO01
Classification: ACTIB
VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15370-104
Product Classification
G
Generic Name
VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (22)
CHOLECALCIFEROLActive
Quantity: 400 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
ASCORBIC ACIDActive
Quantity: 60 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
VITAMIN A ACETATEActive
Quantity: 1200 [iU] in 1 1
Code: 3LE3D9D6OY
Classification: ACTIM
RIBOFLAVINActive
Quantity: 1.3 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
THIAMINE HYDROCHLORIDEActive
Quantity: 1.2 mg in 1 1
Code: M572600E5P
Classification: ACTIR
NIACINAMIDEActive
Quantity: 5 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 1.5 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 4 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
CUPRIC SULFATEActive
Quantity: 1 mg in 1 1
Code: LRX7AJ16DT
Classification: ACTIM
FOLIC ACIDActive
Quantity: 100 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
SODIUM FLUORIDEActive
Quantity: 0.5 mg in 1 1
Code: 8ZYQ1474W7
Classification: ACTIM
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GRAPEInactive
Code: 6X543N684K
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
LEVOMEFOLIC ACIDActive
Quantity: 108 ug in 1 1
Code: 8S95DH25XC
Classification: ACTIB
MAGNESIUM OXIDEActive
Quantity: 15 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Active
Quantity: 15 [iU] in 1 1
Code: 7QWA1RIO01
Classification: ACTIB