Home NDC 85477-309 Hydroxym
Product NDC 85477-309
11-digit product format 854770309
Labeler code 85477
Product ID 85477-309_fd57a6ad-c172-493a-9fc1-84a3fabc181f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROCORTISONE
Dosage form GEL
Route TOPICAL
Labeler Oncora Pharma, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2023-07-12
Substance HYDROCORTISONE
Active strength 2 g/100g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Hydroxym
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 2 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 604449 Internal RxNorm lookup
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 85477-309-28 Hydroxym 28 g in 1 TUBE GEL 28 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85477-309-28 85477030928 28 g in 1 TUBE (85477-309-28) 28 g 2023-07-12 No No Current