Package 83107-022-04

Brand: pramosone

Generic: hydrocortisone acetate and pramoxine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 83107-022-04
Digits Only 8310702204
Product NDC 83107-022
Product ID 83107-022_3727af4b-5b76-ef65-e063-6294a90afbad
Description

118 mL in 1 BOTTLE (83107-022-04)

Marketing

Marketing Status
Marketed Since 2025-06-06
Brand pramosone
Generic hydrocortisone acetate and pramoxine hydrochloride
Sample Package No

Linked Drug Pages (1)

Pramosone ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3727af4b-5b76-ef65-e063-6294a90afbad", "openfda": {"upc": ["0383107022046"], "unii": ["3X7931PO74", "88AYB867L5"], "rxcui": ["1234393", "1234396"], "spl_set_id": ["ce3dd32c-1262-454e-aacb-880d54596dd3"], "manufacturer_name": ["Legacy Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (83107-022-04)", "package_ndc": "83107-022-04", "marketing_start_date": "20250606"}], "brand_name": "Pramosone", "product_id": "83107-022_3727af4b-5b76-ef65-e063-6294a90afbad", "dosage_form": "LOTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "83107-022", "generic_name": "hydrocortisone acetate and pramoxine hydrochloride", "labeler_name": "Legacy Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pramosone", "active_ingredients": [{"name": "HYDROCORTISONE ACETATE", "strength": "10 mg/mL"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA085980", "marketing_category": "ANDA", "marketing_start_date": "20250606", "listing_expiration_date": "20261231"}