hydrocortisone 1%

Generic: hydrocortisone

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

Drug Facts

Product Profile

Brand Name hydrocortisone 1%
Generic Name hydrocortisone
Labeler trifecta pharmaceuticals usa llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 1 g/100g

Manufacturer
Trifecta Pharmaceuticals Usa Llc

Identifiers & Regulatory

Product NDC 69396-050
Product ID 69396-050_4c363aee-bd3b-680f-e063-6294a90a283b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2027-12-31
Marketing Start 2019-12-12

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 69396050
Hyphenated Format 69396-050

Supplemental Identifiers

RxCUI
106258
UPC
0860001004939
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 1% (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 (69396-050-01) / 28.4 g in 1 TUBE
  • 1 TUBE in 1 BOX (69396-050-05) / 14.2 g in 1 TUBE
source: ndc

Packages (2)

69396-050-01 1 TUBE in 1 BOX (69396-050-01) / 28.4 g in 1 TUBE 69396-050-05 1 TUBE in 1 BOX (69396-050-05) / 14.2 g in 1 TUBE

Ingredients (1)

hydrocortisone (1 g/100g)

Linked Drug Pages (1)

Hydrocortisone 1% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4c363aee-bd3b-680f-e063-6294a90a283b", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0860001004939"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["9987165c-1a0f-dd57-e053-2a95a90ae735"], "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 (69396-050-01)  / 28.4 g in 1 TUBE", "package_ndc": "69396-050-01", "marketing_start_date": "20191212"}, {"sample": false, "description": "1 TUBE in 1 BOX (69396-050-05)  / 14.2 g in 1 TUBE", "package_ndc": "69396-050-05", "marketing_start_date": "20220901"}], "brand_name": "Hydrocortisone 1%", "product_id": "69396-050_4c363aee-bd3b-680f-e063-6294a90a283b", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "69396-050", "generic_name": "Hydrocortisone", "labeler_name": "Trifecta Pharmaceuticals Usa Llc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hydrocortisone 1%", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "1 g/100g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20191212", "listing_expiration_date": "20271231"}