hydrocortisone cream

Generic: hydrocortisone cream

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone cream
Generic Name hydrocortisone cream
Labeler direct_rx
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 25 mg/g

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-554
Product ID 72189-554_4c4aca2b-8477-c3a1-e063-6394a90a70f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085025
Listing Expiration 2027-12-31
Marketing Start 2024-05-30

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 72189554
Hyphenated Format 72189-554

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 cream (source: ndc)
Generic Name hydrocortisone cream (source: ndc)
Application Number ANDA085025 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/g
source: ndc
Packaging
  • 20 g in 1 TUBE (72189-554-28)
  • 28.4 g in 1 TUBE (72189-554-30)
source: ndc

Packages (2)

72189-554-28 20 g in 1 TUBE (72189-554-28) 72189-554-30 28.4 g in 1 TUBE (72189-554-30)

Ingredients (1)

hydrocortisone (25 mg/g)

Linked Drug Pages (1)

Hydrocortisone Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4c4aca2b-8477-c3a1-e063-6394a90a70f6", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["310891"], "spl_set_id": ["19b09776-165a-9579-e063-6294a90a9d39"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "20 g in 1 TUBE (72189-554-28)", "package_ndc": "72189-554-28", "marketing_start_date": "20240530"}, {"sample": false, "description": "28.4 g in 1 TUBE (72189-554-30)", "package_ndc": "72189-554-30", "marketing_start_date": "20240530"}], "brand_name": "Hydrocortisone Cream", "product_id": "72189-554_4c4aca2b-8477-c3a1-e063-6394a90a70f6", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "72189-554", "generic_name": "Hydrocortisone Cream", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone Cream", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "25 mg/g"}], "application_number": "ANDA085025", "marketing_category": "ANDA", "marketing_start_date": "20240530", "listing_expiration_date": "20271231"}