epifoam

Generic: pramoxine hydrochloride and hydrocortisone acetate

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name epifoam
Generic Name pramoxine hydrochloride and hydrocortisone acetate
Labeler viatris specialty llc
Dosage Form AEROSOL, FOAM
Routes
TOPICAL
Active Ingredients

hydrocortisone acetate 100 mg/10g, pramoxine hydrochloride 100 mg/10g

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 0037-6824
Product ID 0037-6824_c99db232-5398-45ed-a621-83448f51f5ae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086457
Listing Expiration 2026-12-31
Marketing Start 2014-08-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00376824
Hyphenated Format 0037-6824

Supplemental Identifiers

RxCUI
904782 904783
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 epifoam (source: ndc)
Generic Name pramoxine hydrochloride and hydrocortisone acetate (source: ndc)
Application Number ANDA086457 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/10g
source: ndc
Packaging
  • 1 CANISTER in 1 CARTON (0037-6824-10) / 10 g in 1 CANISTER
source: ndc

Packages (1)

0037-6824-10 1 CANISTER in 1 CARTON (0037-6824-10) / 10 g in 1 CANISTER

Ingredients (2)

hydrocortisone acetate (100 mg/10g) pramoxine hydrochloride (100 mg/10g)

Linked Drug Pages (1)

EPIFOAM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "c99db232-5398-45ed-a621-83448f51f5ae", "openfda": {"unii": ["3X7931PO74", "88AYB867L5"], "rxcui": ["904782", "904783"], "spl_set_id": ["b22b8b41-2f1e-11e4-8c21-0800200c9a66"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CANISTER in 1 CARTON (0037-6824-10)  / 10 g in 1 CANISTER", "package_ndc": "0037-6824-10", "marketing_start_date": "20140825"}], "brand_name": "EPIFOAM", "product_id": "0037-6824_c99db232-5398-45ed-a621-83448f51f5ae", "dosage_form": "AEROSOL, FOAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0037-6824", "generic_name": "pramoxine hydrochloride and hydrocortisone acetate", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EPIFOAM", "active_ingredients": [{"name": "HYDROCORTISONE ACETATE", "strength": "100 mg/10g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "100 mg/10g"}], "application_number": "ANDA086457", "marketing_category": "ANDA", "marketing_start_date": "20140825", "listing_expiration_date": "20261231"}