pramosone cream

Generic: hydrocortisone acetate and pramoxine hydrochloride

Labeler: sebela pharmaceuticals 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 sebela pharmaceuticals inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Sebela Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 54766-716
Product ID 54766-716_431495fb-6225-9c16-e063-6394a90a14ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085368
Marketing Start 2015-08-04
Marketing End 2026-07-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54766716
Hyphenated Format 54766-716

Supplemental Identifiers

RxCUI
1116499 1234519
UPC
0354766716034 0354766716041
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 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 (54766-716-03)
  • 28.4 g in 1 TUBE (54766-716-04)
source: ndc

Packages (2)

54766-716-03 57 g in 1 TUBE (54766-716-03) 54766-716-04 28.4 g in 1 TUBE (54766-716-04)

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": "431495fb-6225-9c16-e063-6394a90a14ba", "openfda": {"upc": ["0354766716034", "0354766716041"], "unii": ["3X7931PO74", "88AYB867L5"], "rxcui": ["1116499", "1234519"], "spl_set_id": ["3e8422e0-3bb3-11e5-8cb0-0002a5d5c51b"], "manufacturer_name": ["Sebela Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "57 g in 1 TUBE (54766-716-03)", "package_ndc": "54766-716-03", "marketing_end_date": "20260731", "marketing_start_date": "20150804"}, {"sample": false, "description": "28.4 g in 1 TUBE (54766-716-04)", "package_ndc": "54766-716-04", "marketing_end_date": "20260731", "marketing_start_date": "20150804"}], "brand_name": "Pramosone Cream", "product_id": "54766-716_431495fb-6225-9c16-e063-6394a90a14ba", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "54766-716", "generic_name": "hydrocortisone acetate and pramoxine hydrochloride", "labeler_name": "Sebela Pharmaceuticals 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_end_date": "20260731", "marketing_start_date": "20150804"}