hydrocortisone

Generic: hydrocortisone

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler actavis pharma, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 10 mg/g

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0472-0321
Product ID 0472-0321_9c878619-0930-40f2-b1a6-e92328a25fb2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087795
Marketing Start 2002-01-03
Marketing End 2026-10-31

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 04720321
Hyphenated Format 0472-0321

Supplemental Identifiers

RxCUI
106258
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 ANDA087795 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0472-0321-26) / 28.4 g in 1 TUBE
source: ndc

Packages (1)

0472-0321-26 1 TUBE in 1 CARTON (0472-0321-26) / 28.4 g in 1 TUBE

Ingredients (1)

hydrocortisone (10 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": "9c878619-0930-40f2-b1a6-e92328a25fb2", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["aa9dba84-eb38-4ec3-8555-87c948bf2384"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0472-0321-26)  / 28.4 g in 1 TUBE", "package_ndc": "0472-0321-26", "marketing_end_date": "20261031", "marketing_start_date": "20020103"}], "brand_name": "Hydrocortisone", "product_id": "0472-0321_9c878619-0930-40f2-b1a6-e92328a25fb2", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0472-0321", "generic_name": "Hydrocortisone", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "10 mg/g"}], "application_number": "ANDA087795", "marketing_category": "ANDA", "marketing_end_date": "20261031", "marketing_start_date": "20020103"}