sionbiotext hydrocortisone

Generic: hydrocortisone acetate 1%

Labeler: sion biotext medical ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sionbiotext hydrocortisone
Generic Name hydrocortisone acetate 1%
Labeler sion biotext medical ltd
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone acetate .1 g/g

Manufacturer
Sion Biotext Medical Ltd

Identifiers & Regulatory

Product NDC 68786-001
Product ID 68786-001_35074279-3e3d-2a74-e063-6294a90af26f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2025-05-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68786001
Hyphenated Format 68786-001

Supplemental Identifiers

UNII
3X7931PO74

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 sionbiotext hydrocortisone (source: ndc)
Generic Name hydrocortisone acetate 1% (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .1 g/g
source: ndc
Packaging
  • 28.3 g in 1 BOX (68786-001-28)
source: ndc

Packages (1)

68786-001-28 28.3 g in 1 BOX (68786-001-28)

Ingredients (1)

hydrocortisone acetate (.1 g/g)

Linked Drug Pages (1)

SionBiotext Hydrocortisone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "35074279-3e3d-2a74-e063-6294a90af26f", "openfda": {"unii": ["3X7931PO74"], "spl_set_id": ["35073eae-26fe-2bb5-e063-6294a90ab56a"], "manufacturer_name": ["Sion Biotext Medical Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28.3 g in 1 BOX (68786-001-28)", "package_ndc": "68786-001-28", "marketing_start_date": "20250513"}], "brand_name": "SionBiotext Hydrocortisone", "product_id": "68786-001_35074279-3e3d-2a74-e063-6294a90af26f", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68786-001", "generic_name": "Hydrocortisone Acetate 1%", "labeler_name": "Sion Biotext Medical Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SionBiotext Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE ACETATE", "strength": ".1 g/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250513", "listing_expiration_date": "20261231"}