Home NDC 85477-922 Gestyra
Product NDC 85477-922
11-digit product format 854770922
Labeler code 85477
Product ID 85477-922_d8c1b301-80ad-4afa-9cf8-b0d8ddd6992c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDE
Dosage form TABLET
Route ORAL
Labeler Oncora Pharma LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2025-12-22
Substance ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE; PYRIDOXAL PHOSPHATE ANHYDROUS; FOLIC ACID; METHYLCOBALAMIN; CALCIUM CARBONATE; FERROUS GLUCONATE; POTASSIUM IODIDE
Active strength 125; 12.5; 1.4; 2.5; 1; 1000; 200; 13; .15 mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1
Pharmacologic classes Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 Gestyra
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ASCORBIC ACID 125 mg/1 CHOLECALCIFEROL 12.5 ug/1 THIAMINE 1.4 mg/1 PYRIDOXAL PHOSPHATE ANHYDROUS 2.5 mg/1 FOLIC ACID 1 mg/1 METHYLCOBALAMIN 1000 ug/1 CALCIUM CARBONATE 200 mg/1 FERROUS GLUCONATE 13 mg/1 POTASSIUM IODIDE .15 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 9 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 85477-922-30 Gestyra 30 in 1 BOTTLE, PLASTIC TABLET 30 1
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gestyra ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDE Oncora Pharma LLC f10bf225-c125-4711-893a-78e15be815bb 2025-12-30 Warnings Exact identifier ndc (product): 85477-922
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85477-922-30 85477092230 30 TABLET in 1 BOTTLE, PLASTIC (85477-922-30) 30 tablet 2025-12-22 No No Current