hydrocortisone acetate cream

Generic: hydrocortisone acetate cream

Labeler: allegis holdings llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone acetate cream
Generic Name hydrocortisone acetate cream
Labeler allegis holdings llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone acetate 20 mg/g

Manufacturer
Allegis Holdings LLC

Identifiers & Regulatory

Product NDC 71297-241
Product ID 71297-241_3b007d65-4f52-825f-e063-6294a90a71bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040396
Listing Expiration 2026-12-31
Marketing Start 2025-07-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71297241
Hyphenated Format 71297-241

Supplemental Identifiers

UPC
0371297241019
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 hydrocortisone acetate cream (source: ndc)
Generic Name hydrocortisone acetate cream (source: ndc)
Application Number ANDA040396 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 28.4 g in 1 CARTON (71297-241-01)
source: ndc

Packages (1)

71297-241-01 28.4 g in 1 CARTON (71297-241-01)

Ingredients (1)

hydrocortisone acetate (20 mg/g)

Linked Drug Pages (1)

Hydrocortisone Acetate Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3b007d65-4f52-825f-e063-6294a90a71bb", "openfda": {"upc": ["0371297241019"], "unii": ["3X7931PO74"], "spl_set_id": ["3b008546-afa5-fe5a-e063-6394a90adb3b"], "manufacturer_name": ["Allegis Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28.4 g in 1 CARTON (71297-241-01)", "package_ndc": "71297-241-01", "marketing_start_date": "20250728"}], "brand_name": "Hydrocortisone Acetate Cream", "product_id": "71297-241_3b007d65-4f52-825f-e063-6294a90a71bb", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "71297-241", "generic_name": "Hydrocortisone Acetate Cream", "labeler_name": "Allegis Holdings LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone Acetate Cream", "active_ingredients": [{"name": "HYDROCORTISONE ACETATE", "strength": "20 mg/g"}], "application_number": "ANDA040396", "marketing_category": "ANDA", "marketing_start_date": "20250728", "listing_expiration_date": "20261231"}