pramosone

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
Generic Name hydrocortisone acetate and pramoxine hydrochloride
Labeler legacy pharma usa inc.
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Legacy Pharma USA Inc.

Identifiers & Regulatory

Product NDC 83107-022
Product ID 83107-022_3727af4b-5b76-ef65-e063-6294a90afbad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085980
Listing Expiration 2026-12-31
Marketing Start 2025-06-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83107022
Hyphenated Format 83107-022

Supplemental Identifiers

RxCUI
1234393 1234396
UPC
0383107022046
UNII
3X7931PO74 88AYB867L5

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 (source: ndc)
Generic Name hydrocortisone acetate and pramoxine hydrochloride (source: ndc)
Application Number ANDA085980 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (83107-022-04)
source: ndc

Packages (1)

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

Ingredients (2)

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

Linked Drug Pages (1)

Pramosone ndc-match (0.9)

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"}