hydrocortisone

Generic: hydrocortisone

Labeler: sportpharm, inc. dba sportpharm
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler sportpharm, inc. dba sportpharm
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 25 mg/g

Manufacturer
Sportpharm, Inc. dba Sportpharm

Identifiers & Regulatory

Product NDC 85766-085
Product ID 85766-085_40c85322-c547-b8fa-e063-6294a90a8198
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080706
Listing Expiration 2026-12-31
Marketing Start 2016-04-01

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 85766085
Hyphenated Format 85766-085

Supplemental Identifiers

RxCUI
310891
UNII
WI4X0X7BPJ
NUI
N0000175576 N0000175450

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 ANDA080706 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (85766-085-30) / 30 g in 1 TUBE
source: ndc

Packages (1)

85766-085-30 1 TUBE in 1 CARTON (85766-085-30) / 30 g in 1 TUBE

Ingredients (1)

hydrocortisone (25 mg/g)

Linked Drug Pages (1)

Hydrocortisone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "40c85322-c547-b8fa-e063-6294a90a8198", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["310891"], "spl_set_id": ["78f43570-b6fd-42eb-bb9e-580abf79bf0d"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Sportpharm, Inc. dba Sportpharm"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (85766-085-30)  / 30 g in 1 TUBE", "package_ndc": "85766-085-30", "marketing_start_date": "20251010"}], "brand_name": "Hydrocortisone", "product_id": "85766-085_40c85322-c547-b8fa-e063-6294a90a8198", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "85766-085", "generic_name": "Hydrocortisone", "labeler_name": "Sportpharm, Inc. dba Sportpharm", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "25 mg/g"}], "application_number": "ANDA080706", "marketing_category": "ANDA", "marketing_start_date": "20160401", "listing_expiration_date": "20261231"}