Home NDC 0904-7340-12 Hydrocortisone Acetate
Product NDC 0904-7340
Requested package NDC 0904-7340-12
11-digit product format 009047340
Labeler code 0904
Product ID 0904-7340_3c4abda4-841e-4b4e-8014-7c0ec3b66b39
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone Acetate
Dosage form SUPPOSITORY
Route RECTAL
Labeler Major Pharmaceuticals
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-04-05
Marketing end 2027-02-28
Substance HYDROCORTISONE ACETATE
Active strength 25 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Hydrocortisone Acetate 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 0904-7340-12 Hydrocortisone Acetate 12 in 1 CARTON SUPPOSITORY 12 2 0904-7340-24 Hydrocortisone Acetate 24 in 1 CARTON SUPPOSITORY 24 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7340 HYDROCORTISONE ACETATE SUPPOSITORY [MAJOR PHARMACEUTICALS] 1 Current NDC, 2 package rows 20240410_1281a82d-df00-4421-9c0d-951f8f9a9422.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 0904-7340-12 00904734012 12 SUPPOSITORY in 1 CARTON (0904-7340-12) 12 suppository 2024-04-05 2027-02-28 No No Historical