Home NDC 50090-2931 Procto-Med HC
Product NDC 50090-2931
11-digit product format 500902931
Labeler code 50090
Product ID 50090-2931_673934c1-59c3-4fa4-878f-0a8111071c2d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROCORTISONE
Dosage form CREAM
Route TOPICAL
Labeler A-S Medication Solutions
Application ANDA089682
Marketing category ANDA
Marketing start 2016-05-09
Marketing end 0000-00-00
Substance HYDROCORTISONE
Active strength 25 mg/g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 50090-2931 I Inactivated by FDA 2026-07-31 excluded package package 50090-2931 50090-2931-0 I Inactivated by FDA 2026-07-31
Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A089682-001 HYDROCORTISONE HYDROCORTISONE 2.5% CREAM / TOPICAL 1988-03-10
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.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria. To report SUSPECTED ADVERSE EVENTS, contact the FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-2931-0 Procto-Med HC 1 in 1 CARTON CREAM 1 9 50090-2931-0 Procto-Med HC 30 g in 1 TUBE CREAM 30 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-2931 PROCTO-MED HC (HYDROCORTISONE) CREAM [A-S MEDICATION SOLUTIONS] 9 Legacy NDC, 2 package rows 20200122_70a7d1b6-a460-43c9-8aed-519f0cdd558b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-2931-0 50090293100 1 TUBE in 1 CARTON (50090-2931-0) > 30 g in 1 TUBE 1 tube 2017-03-23 0000-00-00 No No Current