hydrocortisone acetate pramoxine hydrochloride

Generic: pramoxine hydrochloride and hydrocortisone acetate

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

Drug Facts

Product Profile

Brand Name hydrocortisone acetate pramoxine hydrochloride
Generic Name pramoxine hydrochloride and hydrocortisone acetate
Labeler nivagen pharmaceuticals inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone acetate 25 mg/g, pramoxine hydrochloride 10 mg/g

Manufacturer
Nivagen Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 75834-197
Product ID 75834-197_53ac723b-1f67-47e5-b560-6589342a27d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2019-04-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75834197
Hyphenated Format 75834-197

Supplemental Identifiers

RxCUI
1294025
UPC
0375834197012
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 hydrocortisone acetate pramoxine hydrochloride (source: ndc)
Generic Name pramoxine hydrochloride and hydrocortisone acetate (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/g
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (75834-197-01) / 28.5 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

75834-197-01 1 TUBE, WITH APPLICATOR in 1 CARTON (75834-197-01) / 28.5 g in 1 TUBE, WITH APPLICATOR

Ingredients (2)

hydrocortisone acetate (25 mg/g) pramoxine hydrochloride (10 mg/g)

Linked Drug Pages (1)

HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "53ac723b-1f67-47e5-b560-6589342a27d8", "openfda": {"upc": ["0375834197012"], "unii": ["3X7931PO74", "88AYB867L5"], "rxcui": ["1294025"], "spl_set_id": ["dc7f17e4-76f8-4cd4-a7e3-43032b386b74"], "manufacturer_name": ["Nivagen Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (75834-197-01)  / 28.5 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "75834-197-01", "marketing_start_date": "20190429"}], "brand_name": "HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE", "product_id": "75834-197_53ac723b-1f67-47e5-b560-6589342a27d8", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "75834-197", "generic_name": "PRAMOXINE HYDROCHLORIDE and HYDROCORTISONE ACETATE", "labeler_name": "Nivagen Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE", "active_ingredients": [{"name": "HYDROCORTISONE ACETATE", "strength": "25 mg/g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20190429", "listing_expiration_date": "20261231"}