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 19 of 20 · 389 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hydrocortisone HYDROCORTISONE 1% Weeks & Leo Co., Inc. 0c5325e3-4796-856c-e063-6394a90a1f90 2023-12-12 Warnings Name fallback brand name: Hydrocortisone Westlake Anti-itch HYDROCORTISONE Westlake Pharma LLC 0c53c982-3f23-a2d5-e063-6394a90acd55 2023-12-12 Warnings Name fallback generic name: HYDROCORTISONE Rite Aid Anti-itch HYDROCORTISONE Rite Aid 0c540422-1579-9217-e063-6294a90ad06a 2023-12-12 Warnings Name fallback generic name: HYDROCORTISONE Anti-itch Paraben Free HYDROCORTISONE Weeks & Leo Co., Inc. 0c5419c5-0929-7ca6-e063-6294a90ac0a7 2023-12-12 Warnings Name fallback generic name: HYDROCORTISONE Anti itch HYDROCORTISONE Weeks & Leo Co., Inc. 0c58b750-d3a6-5ed1-e063-6294a90a4321 2023-12-12 Warnings Name fallback generic name: HYDROCORTISONE Quatriderm Anti-itch HYDROCORTISONE OPMX LLC 83e59e10-9878-e5c2-e053-2a91aa0af25e 2023-12-04 Warnings Name fallback generic name: HYDROCORTISONE Bloop Itch Soothing Topical HYDROCORTISONE Three Nations Corp 0b64677e-d4bf-0929-e063-6294a90af137 2023-11-30 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE A-S Medication Solutions 5ee2f62a-d8d5-4efd-bf6f-f79c10855631 2023-11-22 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone ANTIPRURITIC (ANTI-ITCH) BluePoint Laboratories b505769e-9c46-3cf3-e053-2a95a90a4df9 2023-11-17 Warnings Name fallback brand name: Hydrocortisone Hydrocortisone ANTIPRURITIC (ANTI-ITCH) BluePoint Laboratories d6523993-d781-cdbc-e053-2a95a90af191 2023-11-17 Warnings Name fallback brand name: Hydrocortisone TOTAL RELIEF HYDROCORTISONE DR. MARDER SKINCARE, LLC 2c05459c-5a2c-45ab-b534-87f966b41681 2023-11-11 Warnings Name fallback generic name: HYDROCORTISONE KERA HC HYDROCORTISONE Clinical Therapeutic Solutions ac215c8f-b224-480c-9295-3a34316293ba 2023-11-10 Warnings Name fallback generic name: HYDROCORTISONE SKIN A COOL Hydrocortisone Anti-Itch HYDROCORTISONE Ana-Cool, LLC e3ea7406-e494-4038-9b28-8d0a28b4b834 2023-11-10 Warnings Name fallback generic name: HYDROCORTISONE Ana Cool Rapid Soothing Cooling Formula HYDROCORTISONE Ana-Cool, LLC 64b80cc2-e2d8-4535-aaf8-c031f4159cd1 2023-11-05 Warnings Name fallback generic name: HYDROCORTISONE Dr. Sheffield Hydrocortisone Anti itch HYDROCORTISONE Sheffield Pharmaceuticals LLC 71c9f2f4-2188-45eb-b55e-3856ac78070b 2023-10-30 Warnings Name fallback generic name: HYDROCORTISONE Thera plus Anti-itch with aloe Hydrocortisone HYDROCORTISONE Fourstar Group USA, Inc. c69d0670-a65b-1680-e053-2995a90a2ee5 2023-10-26 Warnings Name fallback generic name: HYDROCORTISONE Assured HYDROCORTISONE Zhejiang Jingwei Pharmaceutic Al Co., Ltd. bc97f364-9443-47b8-9c2d-b5dcc00cc9b7 2023-10-25 Warnings Name fallback generic name: HYDROCORTISONE Thera Plus HYDROCORTISONE Zhejiang Jingwei Pharmaceutical Co., Ltd. bcc99e5a-2403-46da-9c9d-8411fa4104e0 2023-10-25 Warnings Name fallback generic name: HYDROCORTISONE Family Wellness HYDROCORTISONE Zhejiang Jingwei Pharmaceutical Co., Ltd. cddc9c4a-7c58-4225-921a-05d6afb49178 2023-10-24 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Bryant Ranch Prepack b33f51f5-7506-43d3-863b-406dc5c7d167 2023-07-18 Adverse reactions Name fallback brand name: Hydrocortisone 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