Package 83107-016-02

Brand: pramosone cream

Generic: hydrocortisone acetate and pramoxine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 83107-016-02
Digits Only 8310701602
Product NDC 83107-016
Product ID 83107-016_38cf2148-3f22-d6dd-e063-6394a90a5dbd
Description

57 g in 1 TUBE (83107-016-02)

Marketing

Marketing Status
Marketed Since 2025-06-27
Brand pramosone cream
Generic hydrocortisone acetate and pramoxine hydrochloride
Sample Package No

Linked Drug Pages (1)

Pramosone Cream ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "38cf2148-3f22-d6dd-e063-6394a90a5dbd", "openfda": {"upc": ["0383107016021"], "unii": ["88AYB867L5", "3X7931PO74"], "rxcui": ["1116499", "1234519"], "spl_set_id": ["6a9fb75b-a2f7-4eca-8dce-d7eb5c122476"], "manufacturer_name": ["Legacy Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "57 g in 1 TUBE (83107-016-02)", "package_ndc": "83107-016-02", "marketing_start_date": "20250627"}], "brand_name": "Pramosone Cream", "product_id": "83107-016_38cf2148-3f22-d6dd-e063-6394a90a5dbd", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "83107-016", "generic_name": "hydrocortisone acetate and pramoxine hydrochloride", "labeler_name": "Legacy Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pramosone Cream", "active_ingredients": [{"name": "HYDROCORTISONE ACETATE", "strength": "10 mg/g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/g"}], "application_number": "ANDA085368", "marketing_category": "ANDA", "marketing_start_date": "20250627", "listing_expiration_date": "20261231"}