hydrocortisone acetate

Generic: hydrocortisone acetate

Labeler: nivagen 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 nivagen pharmaceuticals, inc.
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

hydrocortisone acetate 25 mg/1

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-147
Product ID 75834-147_fe395d7c-ccaa-4f49-a902-70a9f6fce571
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2020-05-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75834147
Hyphenated Format 75834-147

Supplemental Identifiers

RxCUI
1291082
UPC
0375834147246
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
  • 2 BLISTER PACK in 1 CARTON (75834-147-12) / 6 SUPPOSITORY in 1 BLISTER PACK (75834-147-06)
  • 4 BLISTER PACK in 1 CARTON (75834-147-24) / 6 SUPPOSITORY in 1 BLISTER PACK (75834-147-06)
source: ndc

Packages (2)

75834-147-12 2 BLISTER PACK in 1 CARTON (75834-147-12) / 6 SUPPOSITORY in 1 BLISTER PACK (75834-147-06) 75834-147-24 4 BLISTER PACK in 1 CARTON (75834-147-24) / 6 SUPPOSITORY in 1 BLISTER PACK (75834-147-06)

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": "fe395d7c-ccaa-4f49-a902-70a9f6fce571", "openfda": {"upc": ["0375834147246"], "unii": ["3X7931PO74"], "rxcui": ["1291082"], "spl_set_id": ["7743779d-1e42-4b23-bde5-0d77fe95bb2b"], "manufacturer_name": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (75834-147-12)  / 6 SUPPOSITORY in 1 BLISTER PACK (75834-147-06)", "package_ndc": "75834-147-12", "marketing_start_date": "20200515"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (75834-147-24)  / 6 SUPPOSITORY in 1 BLISTER PACK (75834-147-06)", "package_ndc": "75834-147-24", "marketing_start_date": "20200515"}], "brand_name": "HYDROCORTISONE ACETATE", "product_id": "75834-147_fe395d7c-ccaa-4f49-a902-70a9f6fce571", "dosage_form": "SUPPOSITORY", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "75834-147", "generic_name": "HYDROCORTISONE ACETATE", "labeler_name": "Nivagen 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": "20200515", "listing_expiration_date": "20261231"}