hydrocortisone

Generic: hydrocortisone

Labeler: encube ethicals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler encube ethicals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 1 g/100g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-096
Product ID 21922-096_00f13ac4-5e1e-4ff8-8a9f-50a7c272ea20
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2025-02-25

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922096
Hyphenated Format 21922-096

Supplemental Identifiers

RxCUI
106258
UPC
0321922096057
UNII
WI4X0X7BPJ
NUI
N0000175576 N0000175450

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hydrocortisone (source: ndc)
Generic Name hydrocortisone (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-096-04) / 14 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-096-05) / 28 g in 1 TUBE
source: ndc

Packages (2)

21922-096-04 1 TUBE in 1 CARTON (21922-096-04) / 14 g in 1 TUBE 21922-096-05 1 TUBE in 1 CARTON (21922-096-05) / 28 g in 1 TUBE

Ingredients (1)

hydrocortisone (1 g/100g)

Linked Drug Pages (1)

HYDROCORTISONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "00f13ac4-5e1e-4ff8-8a9f-50a7c272ea20", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0321922096057"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["969cd576-82d3-4662-bbc1-3587a1f6a564"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (21922-096-04)  / 14 g in 1 TUBE", "package_ndc": "21922-096-04", "marketing_start_date": "20250225"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-096-05)  / 28 g in 1 TUBE", "package_ndc": "21922-096-05", "marketing_start_date": "20250225"}], "brand_name": "HYDROCORTISONE", "product_id": "21922-096_00f13ac4-5e1e-4ff8-8a9f-50a7c272ea20", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "21922-096", "generic_name": "Hydrocortisone", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "HYDROCORTISONE", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "1 g/100g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250225", "listing_expiration_date": "20261231"}