pramosone

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

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

Manufacturer
Sebela Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 54766-729
Product ID 54766-729_4314aef2-c610-9ee4-e063-6394a90ae0ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085980
Marketing Start 2015-07-02
Marketing End 2026-12-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54766729
Hyphenated Format 54766-729

Supplemental Identifiers

RxCUI
1234393 1234396
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 (54766-729-04)
source: ndc

Packages (1)

54766-729-04 118 mL in 1 BOTTLE (54766-729-04)

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": "4314aef2-c610-9ee4-e063-6394a90ae0ca", "openfda": {"unii": ["3X7931PO74", "88AYB867L5"], "rxcui": ["1234393", "1234396"], "spl_set_id": ["f207bdff-2f41-4eee-818e-198b6462863e"], "manufacturer_name": ["Sebela Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (54766-729-04)", "package_ndc": "54766-729-04", "marketing_end_date": "20261231", "marketing_start_date": "20150702"}], "brand_name": "Pramosone", "product_id": "54766-729_4314aef2-c610-9ee4-e063-6394a90ae0ca", "dosage_form": "LOTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "54766-729", "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/mL"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA085980", "marketing_category": "ANDA", "marketing_end_date": "20261231", "marketing_start_date": "20150702"}