Home Applications 040503 Application 040503
Type ANDA
Sponsor LANNETT CO INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYDROCORTISONE HYDROCORTISONE CREAM;TOPICAL 2.5% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040503-001 HYDROCORTISONE HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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 8 of 20 · 400 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hydrocortisone HYDROCORTISONE Trifluent Pharma LLC 20508a94-01bc-4f1d-a42b-122a31402aaf 2025-12-01 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc e2df8130-e7c8-4fde-a6d6-c71378991213 2025-12-01 Warnings Name fallback generic name: HYDROCORTISONE CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc d04e473d-8bbc-475c-a0b1-ca5eed67fbc7 2025-12-01 Warnings Name fallback generic name: HYDROCORTISONE Aquanil HC HYDROCORTISONE Person and Covey 6b9258e4-c7c4-765e-e053-2991aa0a9f4e 2025-11-29 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Henry Schein eb031535-d17e-9d5e-e053-2a95a90ad3e0 2025-11-25 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone ANTI-PRURITIC Cardinal Health 8b3af210-3097-8c10-e053-2a95a90a86f1 2025-11-25 Warnings Name fallback brand name: Hydrocortisone Hydrocortisone ANTI-ITCH Cardinal Health 884c8227-b4f3-7ef1-e053-2995a90a0ee3 2025-11-25 Warnings Name fallback brand name: Hydrocortisone health beyond HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. bdcd5b01-f5e2-4519-bf4d-25e3cc7e67af 2025-11-23 Warnings Name fallback generic name: HYDROCORTISONE Absolut Skin Corticosoothe Anti-Itch HYDROCORTISONE Absolut Skin Incorporated deb52218-9176-4aaa-a22f-b66dada6690f 2025-11-19 Warnings Name fallback generic name: HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE Encube Ethicals, Inc. 969cd576-82d3-4662-bbc1-3587a1f6a564 2025-11-10 Warnings Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE HEALING TREE CALMING ANTI-ITCH HYDROCORTISONE Renu Laboratories, LLC fc8bcde9-26e8-a35f-e053-6394a90a3300 2025-11-06 Warnings Name fallback generic name: HYDROCORTISONE Proctosol-HC HYDROCORTISONE Bryant Ranch Prepack 68e177fd-87aa-45f3-a380-0d092abdb77d 2025-11-05 Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Bryant Ranch Prepack b6808d2d-192c-4d70-a2e8-bf13375c0280 2025-11-05 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone Anti-Itch HYDROCORTISONE Universal Distribution Center LLC 186afb11-06b6-4bfa-e063-6294a90aefc6 2025-10-30 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE SPRAY Meijer Distribution Inc. 28daaf97-b0b3-7a54-e063-6294a90a23f1 2025-10-30 Warnings Name fallback brand name: Hydrocortisone CVS Cools Itch Fast HYDROCORTISONE CVS Pharmacy, Inc. 8a4544df-bbba-47d2-ada0-352757abc91f 2025-10-29 Warnings Name fallback generic name: HYDROCORTISONE Winco Maximum Strength Hydrocortisone HYDROCORTISONE WINCO FOODS, LLC b1812ea3-78cc-607a-e053-2a95a90a0a10 2025-10-29 Warnings Name fallback generic name: HYDROCORTISONE hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 8c03671d-28ab-4027-8f5f-d342177ce5f2 2025-10-28 Adverse reactions Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE CONTINUOUS SPRAY Premier Brands of America, Inc. d344f68b-9b62-3029-e053-2995a90a1665 2025-10-27 Warnings Name fallback brand name: Hydrocortisone WinCo Foods Hydrocortisone Cream Intensive Healing HYDROCORTISONE WINCO FOODS, LLC ac4e0e24-9295-b83b-e053-2995a90a996f 2025-10-22 Warnings Name fallback generic name: HYDROCORTISONE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0527-7781 Hydrocortisone hydrocortisone Lannett Company, Inc. ANDA Current 0603-7781 Hydrocortisone hydrocortisone Par Pharmaceutical ANDA Current 0603-7781 Hydrocortisone hydrocortisone Par Pharmaceutical ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 22148 ORIG 2007-07-06