hydrocortisone acetate pramoxine hcl (45802-144)

Drug Facts

Product Profile

Brand Name hydrocortisone acetate pramoxine hcl

Generic Name hydrocortisone acetate pramoxine hcl

Labeler padagis israel pharmaceuticals ltd

Dosage Form CREAM

Routes

TOPICAL

Active Ingredients

hydrocortisone acetate 1 g/100g, pramoxine hydrochloride 1 g/100g

Manufacturer

Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-144

Product ID 45802-144_d2d16487-bf77-4da4-8fa8-3cf8dd1b98b3

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA085368

Listing Expiration 2026-12-31

Marketing Start 2010-04-13

Pharmacologic Class

Classes

corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802144

Hyphenated Format 45802-144

Supplemental Identifiers

RxCUI

1235049

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 hcl (source: ndc)

Generic Name hydrocortisone acetate pramoxine hcl (source: ndc)

Application Number ANDA085368 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

1 g/100g

source: ndc

Packaging

1 TUBE in 1 CARTON (45802-144-64) / 28.35 g in 1 TUBE

source: ndc

Packages (1)

45802-144-64 1 TUBE in 1 CARTON (45802-144-64) / 28.35 g in 1 TUBE

Ingredients (2)

hydrocortisone acetate (1 g/100g) pramoxine hydrochloride (1 g/100g)

Linked Drug Pages (1)

hydrocortisone acetate pramoxine hcl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "d2d16487-bf77-4da4-8fa8-3cf8dd1b98b3", "openfda": {"unii": ["3X7931PO74", "88AYB867L5"], "rxcui": ["1235049"], "spl_set_id": ["9eea5875-d153-4bba-aee2-b1d1cd8b5e57"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (45802-144-64)  / 28.35 g in 1 TUBE", "package_ndc": "45802-144-64", "marketing_start_date": "20100413"}], "brand_name": "hydrocortisone acetate pramoxine hcl", "product_id": "45802-144_d2d16487-bf77-4da4-8fa8-3cf8dd1b98b3", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "45802-144", "generic_name": "hydrocortisone acetate pramoxine hcl", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "hydrocortisone acetate pramoxine hcl", "active_ingredients": [{"name": "HYDROCORTISONE ACETATE", "strength": "1 g/100g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "1 g/100g"}], "application_number": "ANDA085368", "marketing_category": "ANDA", "marketing_start_date": "20100413", "listing_expiration_date": "20261231"}