hydrocortisone

Generic: hydrocortisone

Labeler: trifecta pharmaceuticals usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler trifecta pharmaceuticals usa llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

hydrocortisone 1 g/100g

Manufacturer
TRIFECTA PHARMACEUTICALS USA LLC

Identifiers & Regulatory

Product NDC 69396-003
Product ID 69396-003_1286af63-33fc-5b93-e063-6294a90a9717
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2015-03-10

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 69396003
Hyphenated Format 69396-003

Supplemental Identifiers

RxCUI
203105
UPC
0094922042019
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 BOX (69396-003-20) / 28.4 g in 1 TUBE
  • 3 TUBE in 1 BOX (69396-003-33) / 28.4 g in 1 TUBE
  • 4 TUBE in 1 BOX (69396-003-44) / 28.4 g in 1 TUBE
source: ndc

Packages (3)

69396-003-20 1 TUBE in 1 BOX (69396-003-20) / 28.4 g in 1 TUBE 69396-003-33 3 TUBE in 1 BOX (69396-003-33) / 28.4 g in 1 TUBE 69396-003-44 4 TUBE in 1 BOX (69396-003-44) / 28.4 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": "1286af63-33fc-5b93-e063-6294a90a9717", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0094922042019"], "unii": ["WI4X0X7BPJ"], "rxcui": ["203105"], "spl_set_id": ["2999fecb-cb15-4023-ade4-ab5822b094d5"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["TRIFECTA PHARMACEUTICALS USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (69396-003-20)  / 28.4 g in 1 TUBE", "package_ndc": "69396-003-20", "marketing_start_date": "20170615"}, {"sample": false, "description": "3 TUBE in 1 BOX (69396-003-33)  / 28.4 g in 1 TUBE", "package_ndc": "69396-003-33", "marketing_start_date": "20240229"}, {"sample": false, "description": "4 TUBE in 1 BOX (69396-003-44)  / 28.4 g in 1 TUBE", "package_ndc": "69396-003-44", "marketing_start_date": "20240228"}], "brand_name": "Hydrocortisone", "product_id": "69396-003_1286af63-33fc-5b93-e063-6294a90a9717", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "69396-003", "generic_name": "HYDROCORTISONE", "labeler_name": "TRIFECTA PHARMACEUTICALS USA LLC", "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": "20150310", "listing_expiration_date": "20261231"}