hydrocortisone

Generic: hydrocortisone 1%

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

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone 1%
Labeler encube ethicals, inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

hydrocortisone 1 g/100g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-098
Product ID 21922-098_1034d4cf-44a2-49b2-9ce8-e1e46caa60de
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2025-03-06

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 21922098
Hyphenated Format 21922-098

Supplemental Identifiers

RxCUI
203105
UPC
0321922098044 0321922098051
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 1% (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 (21922-098-04) / 14 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-098-05) / 28 g in 1 TUBE
source: ndc

Packages (2)

21922-098-04 1 TUBE in 1 CARTON (21922-098-04) / 14 g in 1 TUBE 21922-098-05 1 TUBE in 1 CARTON (21922-098-05) / 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": "1034d4cf-44a2-49b2-9ce8-e1e46caa60de", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0321922098044", "0321922098051"], "unii": ["WI4X0X7BPJ"], "rxcui": ["203105"], "spl_set_id": ["d6f5c0df-6262-4704-bb24-430f66bb2ca8"], "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 (21922-098-04)  / 14 g in 1 TUBE", "package_ndc": "21922-098-04", "marketing_start_date": "20250306"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-098-05)  / 28 g in 1 TUBE", "package_ndc": "21922-098-05", "marketing_start_date": "20250306"}], "brand_name": "Hydrocortisone", "product_id": "21922-098_1034d4cf-44a2-49b2-9ce8-e1e46caa60de", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "21922-098", "generic_name": "Hydrocortisone 1%", "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": "20250306", "listing_expiration_date": "20261231"}