pramosone cream

Generic: hydrocortisone acetate and pramoxine hydrochloride

Labeler: legacy pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pramosone cream
Generic Name hydrocortisone acetate and pramoxine hydrochloride
Labeler legacy pharma usa inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone acetate 10 mg/g, pramoxine hydrochloride 10 mg/g

Manufacturer
Legacy Pharma USA Inc.

Identifiers & Regulatory

Product NDC 83107-016
Product ID 83107-016_38cf2148-3f22-d6dd-e063-6394a90a5dbd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085368
Listing Expiration 2026-12-31
Marketing Start 2025-06-27

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83107016
Hyphenated Format 83107-016

Supplemental Identifiers

RxCUI
1116499 1234519
UPC
0383107016021
UNII
88AYB867L5 3X7931PO74

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 pramosone cream (source: ndc)
Generic Name hydrocortisone acetate and pramoxine hydrochloride (source: ndc)
Application Number ANDA085368 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 57 g in 1 TUBE (83107-016-02)
source: ndc

Packages (1)

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

Ingredients (2)

hydrocortisone acetate (10 mg/g) pramoxine hydrochloride (10 mg/g)

Linked Drug Pages (1)

Pramosone Cream ndc-match (0.9)

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"}