Home NDC 59088-795-54 Folcyteine
Product NDC 59088-795
Requested package NDC 59088-795-54
11-digit product format 590880795
Labeler code 59088
Product ID 59088-795_5592f382-e77e-a812-e063-6294a90a905c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Multivitamin
Dosage form TABLET
Route ORAL
Labeler PureTek Corporation
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2023-09-14
Substance CALCIUM CITRATE; CHOLECALCIFEROL; FOLIC ACID; ACETYLCYSTEINE; MAGNESIUM CITRATE
Active strength 47; 800; 1000; 200; 16 mg/1; [iU]/1; ug/1; mg/1; mg/1
Pharmacologic classes Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Decreased Respiratory Secretion Viscosity [PE], Increased Coagulation Factor Activity [PE], Increased Glutathione Concentration [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Mucolytic [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Reduction Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin D [CS], Vitamin D [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Folcyteine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM CITRATE 47 mg/1 CHOLECALCIFEROL 800 [iU]/1 FOLIC ACID 1000 ug/1 ACETYLCYSTEINE 200 mg/1 MAGNESIUM CITRATE 16 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59088-795-54 Folcyteine 30 in 1 BOTTLE, PLASTIC TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59088-795 FOLCYTEINE (MULTIVITAMIN) TABLET [PURETEK CORPORATION] 1 Current NDC, 1 package rows 20230915_04cf0026-e29b-ffd5-e063-6294a90aca1f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59088-795-54 59088079554 30 TABLET in 1 BOTTLE, PLASTIC (59088-795-54) 30 tablet 2023-09-14 No No Current