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; CALCIUM CARBONATE; CHOLECALCIFEROL; FERROUS GLUCONATE; FOLIC ACID; METHYLCOBALAMIN; POTASSIUM IODIDE; PYRIDOXAL PHOSPHATE ANHYDROUS; THIAMINE
Active strength 125; 200; 12.5; 13; 1; 1000; .15; 2.5; 1.4 mg/1; mg/1; ug/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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
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
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings WARNINGS WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or Poison Control Center immediately.
warnings table WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or Poison Control Center immediately.
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 200 mg/1 THIAMINE 12.5 ug/1 PYRIDOXAL PHOSPHATE ANHYDROUS 13 mg/1 FOLIC ACID 1 mg/1 METHYLCOBALAMIN 1000 ug/1 CALCIUM CARBONATE .15 mg/1 FERROUS GLUCONATE 2.5 mg/1 POTASSIUM IODIDE 1.4 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii PQ6CK8PD0R, 1C6V77QF41, X66NSO3N35, F06SGE49M6, 935E97BOY8, BR1SN1JS2W, H0G9379FGK, U1B11I423Z, 1C4QK22F9J
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
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