Home NDC 53002-3440-2 Hydrocortisone Acetate
Product NDC 53002-3440
Requested package NDC 53002-3440-2
11-digit product format 530023440
Labeler code 53002
Product ID 53002-3440_763c65e0-6c8d-4377-8bc2-95fbc743bcc1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROCORTISONE ACETATE
Dosage form SUPPOSITORY
Route RECTAL
Labeler RPK Pharmaceuticals, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2017-05-01
Marketing end 0000-00-00
Substance HYDROCORTISONE ACETATE
Active strength 25 mg/1
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 53002-3440-1 2025-01-30 Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only 53002-3440-2 2025-01-30 Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only 53002-3440-1 2023-06-07 Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only 53002-3440-2 2023-06-07 Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only 53002-3440-1 2023-01-30 Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only 53002-3440-2 2023-01-30 Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only 53002-3440-1 2020-12-15 Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only 53002-3440-2 2020-12-15 Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only 53002-3440-1 2020-01-31 Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only 53002-3440-2 2020-01-31 Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53002-3440-1 Hydrocortisone Acetate 6 in 1 BOX SUPPOSITORY 6 5 53002-3440-2 Hydrocortisone Acetate 12 in 1 BOX SUPPOSITORY 12 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-3440 HYDROCORTISONE ACETATE SUPPOSITORY [RPK PHARMACEUTICALS, INC.] 5 Legacy NDC, 2 package rows 20230609_97552edd-c419-427f-a46a-5ce3ad413dc4.zip
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 53002-3440-2 53002344002 12 SUPPOSITORY in 1 BOX (53002-3440-2) 12 suppository 2018-10-01 0000-00-00 No No Current