Home NDC 69367-243-12 Hydrocortisone Acetate
Product NDC 69367-243
Requested package NDC 69367-243-12
11-digit product format 693670243
Labeler code 69367
Product ID 69367-243_27e6ec88-81d3-47d2-94d0-7fe6e2265237
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone Acetate
Dosage form SUPPOSITORY
Route RECTAL
Labeler Westminster Pharmaceuticals, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2020-02-05
Substance HYDROCORTISONE ACETATE
Active strength 25 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Hydrocortisone Acetate
Listing expiration 2027-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1291082 Internal RxNorm lookup 1291085 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 69367-243-12 Hydrocortisone Acetate 12 in 1 CARTON SUPPOSITORY 12 10 69367-243-24 Hydrocortisone Acetate 24 in 1 CARTON SUPPOSITORY 24 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69367-243 HYDROCORTISONE ACETATE SUPPOSITORY [WESTMINSTER PHARMACEUTICALS, LLC] 7 Current NDC, Legacy NDC, 2 package rows 20241206_3a29006f-9124-45e7-84a2-48f08bbb5f9c.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 69367-243-12 69367024312 12 SUPPOSITORY in 1 CARTON (69367-243-12) 12 suppository 2020-02-05 0000-00-00 No No Current