Home Applications 040247 Application 040247
Type ANDA
Sponsor TARO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYDROCORTISONE HYDROCORTISONE LOTION;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 A040247-001 HYDROCORTISONE HYDROCORTISONE 2.5% LOTION / TOPICAL 1999-07-23
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 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 1999-07-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 1999-07-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 1999-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 1999-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 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 12 of 20 · 389 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hydrocortisone Cream HYDROCORTISONE Trifecta Pharmaceuticals USA d57a59fb-c8f2-f73b-e053-2995a90a4cdb 2025-05-08 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone Cream HYDROCORTISONE Trifecta Pharmaceuticals USA 4c96ec41-841c-322b-e054-00144ff8d46c 2025-05-08 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE ANI Pharmaceuticals, Inc. 0d7e8e04-9149-4436-bad1-b700e253b7ab 2025-05-05 Warnings, Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE A2A Integrated Pharmaceuticals, LLC 31431866-6fb5-2acd-e063-6294a90ac520 2025-03-31 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE DermaCort Anti-itch HYDROCORTISONE Melaleuca, Inc. 24044b0f-dd1e-4762-82b8-7a28b08c2f77 2025-03-20 Warnings Name fallback generic name: HYDROCORTISONE Post Treatment Repair Cream HYDROCORTISONE Vege Labs LLC. 302d4327-354b-a252-e063-6394a90a20b6 2025-03-12 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Walgreens Co. c22bba5c-bb6f-494e-987a-f6e36c1b4893 2025-03-06 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Thera Plus Hydrocortisone Maximum Strength HYDROCORTISONE FOURSTAR GROUP USA, INC. c2bc8f0c-38ea-4124-bc51-bf22e6751a92 2025-03-04 Warnings Name fallback generic name: HYDROCORTISONE Thera Plus Eczema Hydrocortisone Anti Itch HYDROCORTISONE Fourstar Group USA, Inc. 7c72217b-db9a-4573-9f14-4c11528fa452 2025-03-04 Warnings Name fallback generic name: HYDROCORTISONE Thera Plus Maximum Strength Hydrocortisone HYDROCORTISONE Fourstar Group USA, Inc. fb89dca6-c0c0-4092-b3f5-e59c956c3d6c 2025-03-04 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone with aloe HYDROCORTISONE Encube Ethicals, Inc. 12a1774d-a97e-4787-b6b1-8e8cd40b7b70 2025-02-26 Warnings Name fallback generic name: HYDROCORTISONE Family Wellness Max Strength 1 Hydrocortisone Cream HYDROCORTISONE Family Dollar Stores, Inc bca5ac2c-45cd-44e3-98f1-317a04e44d7d 2025-02-25 Warnings Name fallback generic name: HYDROCORTISONE Cortizone 10 Ultra Soothing Itch Relief HYDROCORTISONE Chattem, Inc. 8a9e2d32-a65f-4253-8041-4146f4e3b738 2025-02-21 Warnings Name fallback generic name: HYDROCORTISONE CORTEF HYDROCORTISONE Pharmacia & Upjohn Company LLC 9ce19944-dd88-4a7b-84ca-b07f4ec23bad 2025-02-17 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE signature care Hydrocortisone HYDROCORTISONE Safeway 9fe16fc5-77e3-47f5-a943-85bc6565c0d4 2025-02-06 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc ded2eb00-88ce-42b7-858e-4645c6f13239 2025-02-05 Warnings, Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Cortizone 10 Intensive Healing Itch Relief Cream HYDROCORTISONE Chattem, Inc. cdbeb825-3152-4f74-9fd1-93bccfc0e31a 2025-02-01 Warnings Name fallback generic name: HYDROCORTISONE Cortizone 10 Soothing Aloe Itch Relief HYDROCORTISONE Chattem, Inc. 1962abb3-6ca7-4934-9efe-20287b1c2a5b 2025-02-01 Warnings Name fallback generic name: HYDROCORTISONE hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 0cb39a3d-4d3b-4820-b3bd-eff642e08a41 2025-01-28 Adverse reactions Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE Gerigentle HYDROCORTISONE GERI-GENTLE CORPORATION 0adfa2f0-9758-5c54-e063-6294a90a461f 2025-01-25 Warnings Name fallback generic name: HYDROCORTISONE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 7588 ORIG 1999-07-23