Home NDC 75834-147-24 HYDROCORTISONE ACETATE
Product NDC 75834-147
Requested package NDC 75834-147-24
11-digit product format 758340147
Labeler code 75834
Product ID 75834-147_fe395d7c-ccaa-4f49-a902-70a9f6fce571
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROCORTISONE ACETATE
Dosage form SUPPOSITORY
Route RECTAL
Labeler Nivagen Pharmaceuticals, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2020-05-15
Substance HYDROCORTISONE ACETATE
Active strength 25 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base HYDROCORTISONE ACETATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE ACETATE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3X7931PO74 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1291082 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 75834-147-12 2023-08-28 Hydrocortisone Acetate, 25 mg Rectal Suppositories 75834-147-24 2023-08-28 Hydrocortisone Acetate, 25 mg Rectal Suppositories 75834-147-12 2023-01-30 Hydrocortisone Acetate, 25 mg Rectal Suppositories 75834-147-24 2023-01-30 Hydrocortisone Acetate, 25 mg Rectal Suppositories 75834-147-12 2021-09-23 Hydrocortisone Acetate, 25 mg Rectal Suppositories 75834-147-24 2021-09-23 Hydrocortisone Acetate, 25 mg Rectal Suppositories 75834-147-12 2021-07-23 Hydrocortisone Acetate, 25 mg Rectal Suppositories 75834-147-24 2021-07-23 Hydrocortisone Acetate, 25 mg Rectal Suppositories
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75834-147-06 HYDROCORTISONE ACETATE 6 in 1 BLISTER PACK SUPPOSITORY 6 4 75834-147-12 HYDROCORTISONE ACETATE 2 in 1 CARTON SUPPOSITORY 2 4 75834-147-24 HYDROCORTISONE ACETATE 4 in 1 CARTON SUPPOSITORY 4 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75834-147 HYDROCORTISONE ACETATE SUPPOSITORY [NIVAGEN PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 3 package rows 20230829_7743779d-1e42-4b23-bde5-0d77fe95bb2b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 75834-147-24 75834014724 4 BLISTER PACK in 1 CARTON (75834-147-24) / 6 SUPPOSITORY in 1 BLISTER PACK (75834-147-06) 4 blister pack 2020-05-15 0000-00-00 No No Current