Home NDC 10135-751-12 Hydrocortisone Acetate
Product NDC 10135-751
Requested package NDC 10135-751-12
11-digit product format 101350751
Labeler code 10135
Product ID 10135-751_43805142-9337-8a32-e063-6294a90a66d7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone Acetate
Dosage form SUPPOSITORY
Route RECTAL
Labeler Marlex Pharmaceuticals, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2022-08-01
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10135-751-12 Hydrocortisone Acetate 12 in 1 CARTON SUPPOSITORY 12 4 10135-751-24 Hydrocortisone Acetate 24 in 1 CARTON SUPPOSITORY 24 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-751 HYDROCORTISONE ACETATE SUPPOSITORY [MARLEX PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20241009_e60473f7-fd00-a477-e053-2a95a90ad4dd.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 10135-751-12 10135075112 12 SUPPOSITORY in 1 CARTON (10135-751-12) 12 suppository 2022-08-01 0000-00-00 No No Current