hydrocortisone

Generic: hydrocortisone

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler ani pharmaceuticals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 25 mg/g

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-431
Product ID 62559-431_4538e1ca-670f-4800-ae86-1a728e6b029b
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 62559431
Hyphenated Format 62559-431

Supplemental Identifiers

RxCUI
106258 310891
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 ANDA080706 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (62559-431-30) / 30 g in 1 TUBE
source: ndc

Packages (1)

62559-431-30 1 TUBE in 1 CARTON (62559-431-30) / 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": "4538e1ca-670f-4800-ae86-1a728e6b029b", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258", "310891"], "spl_set_id": ["b2918ac7-14b5-4372-9055-8caf6f4bcf37"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (62559-431-30)  / 30 g in 1 TUBE", "package_ndc": "62559-431-30", "marketing_start_date": "20160401"}], "brand_name": "Hydrocortisone", "product_id": "62559-431_4538e1ca-670f-4800-ae86-1a728e6b029b", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "62559-431", "generic_name": "Hydrocortisone", "labeler_name": "ANI Pharmaceuticals, Inc.", "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"}