Home NDC 0713-0493 Hydrocortisone Acetate
Product NDC 0713-0493
11-digit product format 007130493
Labeler code 0713
Product ID 0713-0493_0acd8136-06dc-4ea4-e063-6394a90a5b51
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROCORTISONE ACETATE
Dosage form SUPPOSITORY
Route RECTAL
Labeler Cosette Pharmaceuticals, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2021-08-09
Substance HYDROCORTISONE ACETATE
Active strength 30 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 30 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 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 0713-0493-12 Hydrocortisone Acetate 12 in 1 BOX SUPPOSITORY 12 2 0713-0493-12 Hydrocortisone Acetate 1 in 1 PACKET SUPPOSITORY 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0493 HYDROCORTISONE ACETATE SUPPOSITORY [COSETTE PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20231123_c84ab549-1d5c-4646-a041-6cb571812ad8.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 0713-0493-12 00713049312 12 PACKET in 1 BOX (0713-0493-12) / 1 SUPPOSITORY in 1 PACKET 12 packet 2021-08-09 0000-00-00 No No Current