hydrocortisone acetate

Generic: hydrocortisone acetate

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

Drug Facts

Product Profile

Brand Name hydrocortisone acetate
Generic Name hydrocortisone acetate
Labeler marlex pharmaceuticals, inc.
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

hydrocortisone acetate 25 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-751
Product ID 10135-751_43805142-9337-8a32-e063-6294a90a66d7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2022-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10135751
Hyphenated Format 10135-751

Supplemental Identifiers

RxCUI
1291082
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 (source: ndc)
Generic Name hydrocortisone acetate (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 12 SUPPOSITORY in 1 CARTON (10135-751-12)
  • 24 SUPPOSITORY in 1 CARTON (10135-751-24)
source: ndc

Packages (2)

10135-751-12 12 SUPPOSITORY in 1 CARTON (10135-751-12) 10135-751-24 24 SUPPOSITORY in 1 CARTON (10135-751-24)

Ingredients (1)

hydrocortisone acetate (25 mg/1)

Linked Drug Pages (1)

Hydrocortisone Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "43805142-9337-8a32-e063-6294a90a66d7", "openfda": {"unii": ["3X7931PO74"], "rxcui": ["1291082"], "spl_set_id": ["e60473f7-fd00-a477-e053-2a95a90ad4dd"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 SUPPOSITORY in 1 CARTON (10135-751-12)", "package_ndc": "10135-751-12", "marketing_start_date": "20220801"}, {"sample": false, "description": "24 SUPPOSITORY in 1 CARTON (10135-751-24)", "package_ndc": "10135-751-24", "marketing_start_date": "20220801"}], "brand_name": "Hydrocortisone Acetate", "product_id": "10135-751_43805142-9337-8a32-e063-6294a90a66d7", "dosage_form": "SUPPOSITORY", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "10135-751", "generic_name": "Hydrocortisone Acetate", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone Acetate", "active_ingredients": [{"name": "HYDROCORTISONE ACETATE", "strength": "25 mg/1"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20220801", "listing_expiration_date": "20261231"}