hydrocortisone acetate pramoxine hcl

Generic: hydrocortisone acetate pramoxine hcl

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

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 2.5 g/100g, pramoxine hydrochloride 1 g/100g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-472
Product ID 45802-472_3b3e3f07-76c6-488c-8ad5-e5eeb5f528f4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 1996-09-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802472
Hyphenated Format 45802-472

Supplemental Identifiers

RxCUI
1294025
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)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2.5 g/100g
  • 1 g/100g
source: ndc
Packaging
  • 12 TUBE in 1 CARTON (45802-472-53) / 4 g in 1 TUBE (45802-472-01)
  • 1 TUBE in 1 CARTON (45802-472-64) / 28.35 g in 1 TUBE
  • 30 TUBE in 1 CARTON (45802-472-65) / 4 g in 1 TUBE (45802-472-01)
source: ndc

Packages (3)

45802-472-53 12 TUBE in 1 CARTON (45802-472-53) / 4 g in 1 TUBE (45802-472-01) 45802-472-64 1 TUBE in 1 CARTON (45802-472-64) / 28.35 g in 1 TUBE 45802-472-65 30 TUBE in 1 CARTON (45802-472-65) / 4 g in 1 TUBE (45802-472-01)

Ingredients (2)

hydrocortisone acetate (2.5 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": "3b3e3f07-76c6-488c-8ad5-e5eeb5f528f4", "openfda": {"unii": ["3X7931PO74", "88AYB867L5"], "rxcui": ["1294025"], "spl_set_id": ["87a4c494-56f9-48f6-8592-d610c507a4fc"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 TUBE in 1 CARTON (45802-472-53)  / 4 g in 1 TUBE (45802-472-01)", "package_ndc": "45802-472-53", "marketing_start_date": "20100503"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-472-64)  / 28.35 g in 1 TUBE", "package_ndc": "45802-472-64", "marketing_start_date": "20100413"}, {"sample": false, "description": "30 TUBE in 1 CARTON (45802-472-65)  / 4 g in 1 TUBE (45802-472-01)", "package_ndc": "45802-472-65", "marketing_start_date": "20100503"}], "brand_name": "Hydrocortisone Acetate Pramoxine Hcl", "product_id": "45802-472_3b3e3f07-76c6-488c-8ad5-e5eeb5f528f4", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "45802-472", "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": "2.5 g/100g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "1 g/100g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "19960927", "listing_expiration_date": "20261231"}