Package 83107-021-04
Brand: pramosone
Generic: hydrocortisone acetate and pramoxine hydrochloridePackage Facts
Identity
Package NDC
83107-021-04
Digits Only
8310702104
Product NDC
83107-021
Description
118 mL in 1 BOTTLE, PLASTIC (83107-021-04)
Marketing
Marketing Status
Brand
pramosone
Generic
hydrocortisone acetate and pramoxine hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "3726846b-fa95-09cb-e063-6294a90a7bf7", "openfda": {"unii": ["3X7931PO74", "88AYB867L5"], "rxcui": ["1234512", "1234514"], "spl_set_id": ["4c98a01e-ff11-45eb-8732-4bd9157969e8"], "manufacturer_name": ["Legacy Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "59 mL in 1 BOTTLE, PLASTIC (83107-021-02)", "package_ndc": "83107-021-02", "marketing_start_date": "20250527"}, {"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (83107-021-04)", "package_ndc": "83107-021-04", "marketing_start_date": "20250527"}], "brand_name": "Pramosone", "product_id": "83107-021_3726846b-fa95-09cb-e063-6294a90a7bf7", "dosage_form": "LOTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "83107-021", "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": "25 mg/mL"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA085979", "marketing_category": "ANDA", "marketing_start_date": "20250527", "listing_expiration_date": "20261231"}