MedPath

Folcyteine

Folcyteine

Approved
Approval ID

04cf0026-e29b-ffd5-e063-6294a90aca1f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 14, 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.

Multivitamin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59088-795
Product Classification
G
Generic Name
Multivitamin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 14, 2023
FDA Product Classification

INGREDIENTS (12)

CALCIUM CITRATEActive
Quantity: 47 mg in 1 1
Code: MLM29U2X85
Classification: ACTIR
FOLIC ACIDActive
Quantity: 1000 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CHOLECALCIFEROLActive
Quantity: 800 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
ACETYLCYSTEINEActive
Quantity: 200 mg in 1 1
Code: WYQ7N0BPYC
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MAGNESIUM CITRATEActive
Quantity: 16 mg in 1 1
Code: RHO26O1T9V
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Folcyteine - FDA Drug Approval Details