Home NDC 16571-676-42 Hydrocortisone Acetate
Product NDC 16571-676
Requested package NDC 16571-676-42
11-digit product format 165710676
Labeler code 16571
Product ID 16571-676_11c6826c-5e54-4094-b5ba-02b24d1db3fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone Acetate
Dosage form SUPPOSITORY
Route RECTAL
Labeler Rising Pharma Holdings, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2021-02-01
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 · 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 16571-676-21 Hydrocortisone Acetate 12 in 1 CARTON SUPPOSITORY 12 2 16571-676-42 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 16571-676 HYDROCORTISONE ACETATE SUPPOSITORY [RISING PHARMA HOLDINGS, INC.] 1 Current NDC, Legacy NDC, 2 package rows 20220507_de171b0a-3854-4aaa-889e-f2d999c0458c.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 16571-676-42 16571067642 24 SUPPOSITORY in 1 CARTON (16571-676-42) 24 suppository 2021-02-01 0000-00-00 No No Current