pramosone

Generic: hydrocortisone acetate and pramoxine hydrochloride

Labeler: sebela pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name pramosone
Generic Name hydrocortisone acetate and pramoxine hydrochloride
Labeler sebela pharmaceuticals inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Sebela Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 54766-763
Product ID 54766-763_26a40470-e73f-8fb9-e063-6294a90aa179
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Marketing Start 2015-08-05
Marketing End 2026-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54766763
Hyphenated Format 54766-763

Supplemental Identifiers

RxCUI
1234317 1234322
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)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 28.4 g in 1 TUBE (54766-763-04)
source: ndc

Packages (1)

54766-763-04 28.4 g in 1 TUBE (54766-763-04)

Ingredients (2)

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

Linked Drug Pages (1)

pramosone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "26a40470-e73f-8fb9-e063-6294a90aa179", "openfda": {"unii": ["3X7931PO74", "88AYB867L5"], "rxcui": ["1234317", "1234322"], "spl_set_id": ["d4d85400-3bb3-11e5-830e-0002a5d5c51b"], "manufacturer_name": ["Sebela Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28.4 g in 1 TUBE (54766-763-04)", "package_ndc": "54766-763-04", "marketing_end_date": "20260331", "marketing_start_date": "20150805"}], "brand_name": "pramosone", "product_id": "54766-763_26a40470-e73f-8fb9-e063-6294a90aa179", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "54766-763", "generic_name": "hydrocortisone acetate and pramoxine hydrochloride", "labeler_name": "Sebela Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "pramosone", "active_ingredients": [{"name": "HYDROCORTISONE ACETATE", "strength": "10 mg/g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_end_date": "20260331", "marketing_start_date": "20150805"}