hydrocortisone

Generic: hydrocortisone

Labeler: akron pharma inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler akron pharma inc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

hydrocortisone 10 mg/mL

Manufacturer
AKRON PHARMA INC

Identifiers & Regulatory

Product NDC 71399-0120
Product ID 71399-0120_48365a1d-e9d3-a4de-e063-6294a90a815d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2027-12-31
Marketing Start 2024-09-13

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 713990120
Hyphenated Format 71399-0120

Supplemental Identifiers

RxCUI
103403
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 M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (71399-0120-1) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

71399-0120-1 1 BOTTLE in 1 CARTON (71399-0120-1) / 120 mL in 1 BOTTLE

Ingredients (1)

hydrocortisone (10 mg/mL)

Linked Drug Pages (1)

Hydrocortisone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "48365a1d-e9d3-a4de-e063-6294a90a815d", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["103403"], "spl_set_id": ["daad9a1e-98d2-4ce7-9d97-ac5d81905abb"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["AKRON PHARMA INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (71399-0120-1)  / 120 mL in 1 BOTTLE", "package_ndc": "71399-0120-1", "marketing_start_date": "20240913"}], "brand_name": "Hydrocortisone", "product_id": "71399-0120_48365a1d-e9d3-a4de-e063-6294a90a815d", "dosage_form": "LOTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "71399-0120", "generic_name": "Hydrocortisone", "labeler_name": "AKRON PHARMA INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "10 mg/mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240913", "listing_expiration_date": "20271231"}