hydrocortisone

Generic: hydrocortisone

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler padagis israel pharmaceuticals ltd
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 25 mg/g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-004
Product ID 45802-004_4b485448-cd59-492b-89cf-8b0582751e44
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085025
Listing Expiration 2027-12-31
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 45802004
Hyphenated Format 45802-004

Supplemental Identifiers

RxCUI
103401 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 ANDA085025 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (45802-004-02) / 20 g in 1 TUBE
  • 1 TUBE in 1 CARTON (45802-004-03) / 28 g in 1 TUBE
source: ndc

Packages (2)

45802-004-02 1 TUBE in 1 CARTON (45802-004-02) / 20 g in 1 TUBE 45802-004-03 1 TUBE in 1 CARTON (45802-004-03) / 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": "4b485448-cd59-492b-89cf-8b0582751e44", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["103401", "310891"], "spl_set_id": ["7ba59aa6-b828-4048-bf86-90c90d9894a0"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (45802-004-02)  / 20 g in 1 TUBE", "package_ndc": "45802-004-02", "marketing_start_date": "20070131"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-004-03)  / 28 g in 1 TUBE", "package_ndc": "45802-004-03", "marketing_start_date": "20060331"}], "brand_name": "Hydrocortisone", "product_id": "45802-004_4b485448-cd59-492b-89cf-8b0582751e44", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "45802-004", "generic_name": "Hydrocortisone", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "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": "20271231"}