hydrocortisone

Generic: hydrocortisone

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler proficient rx lp
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 25 mg/g

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-135
Product ID 82804-135_e1166b3a-a304-4030-ab51-eb55c6e91afd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085025
Listing Expiration 2026-12-31
Marketing Start 2006-03-31

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 82804135
Hyphenated Format 82804-135

Supplemental Identifiers

RxCUI
310891
UPC
0382804135288
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 ANDA085025 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (82804-135-28) / 28 g in 1 TUBE
source: ndc

Packages (1)

82804-135-28 1 TUBE in 1 CARTON (82804-135-28) / 28 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": "e1166b3a-a304-4030-ab51-eb55c6e91afd", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0382804135288"], "unii": ["WI4X0X7BPJ"], "rxcui": ["310891"], "spl_set_id": ["e1166b3a-a304-4030-ab51-eb55c6e91afd"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (82804-135-28)  / 28 g in 1 TUBE", "package_ndc": "82804-135-28", "marketing_start_date": "20240822"}], "brand_name": "Hydrocortisone", "product_id": "82804-135_e1166b3a-a304-4030-ab51-eb55c6e91afd", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "82804-135", "generic_name": "Hydrocortisone", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "25 mg/g"}], "application_number": "ANDA085025", "marketing_category": "ANDA", "marketing_start_date": "20060331", "listing_expiration_date": "20261231"}