hydrocortisone

Generic: hydrocortisone 1%

Labeler: weeks & leo co., inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone 1%
Labeler weeks & leo co., inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

hydrocortisone 1 g/100g

Manufacturer
Weeks & Leo Co., Inc.

Identifiers & Regulatory

Product NDC 11383-268
Product ID 11383-268_0c5325e3-4797-856c-e063-6394a90a1f90
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2023-10-01

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 11383268
Hyphenated Format 11383-268

Supplemental Identifiers

RxCUI
203105
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
  • 28 g in 1 TUBE (11383-268-01)
  • 59 g in 1 TUBE (11383-268-02)
source: ndc

Packages (2)

11383-268-01 28 g in 1 TUBE (11383-268-01) 11383-268-02 59 g in 1 TUBE (11383-268-02)

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": "0c5325e3-4797-856c-e063-6394a90a1f90", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["203105"], "spl_set_id": ["0c5325e3-4796-856c-e063-6394a90a1f90"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Weeks & Leo Co., Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 g in 1 TUBE (11383-268-01)", "package_ndc": "11383-268-01", "marketing_start_date": "20231001"}, {"sample": false, "description": "59 g in 1 TUBE (11383-268-02)", "package_ndc": "11383-268-02", "marketing_start_date": "20231001"}], "brand_name": "Hydrocortisone", "product_id": "11383-268_0c5325e3-4797-856c-e063-6394a90a1f90", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "11383-268", "generic_name": "Hydrocortisone 1%", "labeler_name": "Weeks & Leo Co., 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": "20231001", "listing_expiration_date": "20261231"}