Home Applications 083365 Application 083365
Type ANDA
Sponsor HIKMA INTL PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYDROCORTISONE HYDROCORTISONE TABLET;ORAL 20MG No No 002 HYDROCORTISONE HYDROCORTISONE TABLET;ORAL 5MG No No 003 HYDROCORTISONE HYDROCORTISONE TABLET;ORAL 10MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A083365-001 HYDROCORTISONE HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 A083365-002 HYDROCORTISONE HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 A083365-003 HYDROCORTISONE HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23
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 4 · 123 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 2026-02-19 14:30 UTC 2026-02 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 8072bd15b7f6…
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 1 of 20 · 392 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 484fe5e4-a058-49c0-a382-c8fc3e20c3b2 2026-08-04 Warnings Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE REMEDYREPACK INC. f0e66726-946b-4f63-b457-2851dc69e6b4 2026-08-03 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Cortizone 10 Itch Relief Massaging Rollerball HYDROCORTISONE Chattem, Inc. 1e27682c-f856-41f1-9935-37540960a4c7 2026-07-31 Warnings Name fallback generic name: HYDROCORTISONE hydrocortisone HYDROCORTISONE Eywa Pharma Inc b3f06d10-2f01-428c-88a4-505c61c87ce8 2026-07-25 Warnings, Adverse reactions Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE AEROSOOTHE HYDROCORTISONE Aero Healthcare US LLC 22b172a2-07e8-4ebb-b0a0-dfe4f25477fa 2026-07-24 Warnings Name fallback generic name: HYDROCORTISONE Barmicil Plus HYDROCORTISONE OPMX LLC 5763b4de-06f2-7b19-e063-6294a90ad068 2026-07-24 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE AKRON PHARMA INC daad9a1e-98d2-4ce7-9d97-ac5d81905abb 2026-07-22 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE LYEON Anti-itch Cream HYDROCORTISONE Guangzhou Xinhongda Trading Service Co., Ltd. 56b773ce-167f-7873-e063-6394a90a9816 2026-07-16 Warnings Name fallback generic name: HYDROCORTISONE Barmicil Plus HYDROCORTISONE OPMX LLC 5698207f-9223-f3a6-e063-6294a90a8ab6 2026-07-14 Warnings Name fallback generic name: HYDROCORTISONE Quadriderm NF HYDROCORTISONE OPMX LLC 5643f850-e0d4-d8d8-e063-6294a90a4260 2026-07-10 Warnings Name fallback generic name: HYDROCORTISONE Drs. Hydrocortisone Aloe Vera HYDROCORTISONE OL PHARMA TECH,LLC 0df06415-5d32-7ef8-e063-6294a90a6e5a 2026-07-09 Warnings Name fallback generic name: HYDROCORTISONE CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc. 560a4abf-31dd-333f-e063-6294a90a3505 2026-07-08 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE LOTION Allegis Holdings LLC 1a27d8fa-4025-ed68-e063-6394a90a4f37 2026-07-08 Warnings, Adverse reactions Name fallback brand name: Hydrocortisone Ala-Scalp HYDROCORTISONE Derm Ventures LLC 61498a40-3b3c-4066-89c8-d99686e2d638 2026-07-08 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE DIPROSPAN HYDROCORTISONE OPMX LLC 55fa9ecb-b843-5748-e063-6294a90a2d53 2026-07-06 Warnings Name fallback generic name: HYDROCORTISONE CVS No Mess Cortisone HYDROCORTISONE Natural Essentials, Inc. 558c94ec-95f1-eb98-e063-6394a90a1e72 2026-07-01 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Encube Ethicals, Inc. 11e120e2-a1ca-477c-b474-bcbb72656705 2026-06-26 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Medi-First Hydrocortisone 1 % Anti-Itch Cream HYDROCORTISONE Unifirst First Aid Corporation 49f04e5d-746d-cbe9-e063-6294a90a7e88 2026-06-16 Warnings Name fallback generic name: HYDROCORTISONE Hydroxym HYDROCORTISONE PureTek Corporation febffc84-e65e-e811-e053-6294a90a0ad1 2026-06-15 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone 1% Anti-ItchCream HYDROCORTISONE Acme United Corporation 5425fc2b-4f25-3e64-e063-6394a90aff49 2026-06-13 Warnings Name fallback generic name: HYDROCORTISONE
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0143-1252 Hydrocortisone Hydrocortisone West-Ward Pharmaceuticals Corp ANDA Current 0143-1253 Hydrocortisone Hydrocortisone West-Ward Pharmaceuticals Corp ANDA Current 0143-1254 Hydrocortisone Hydrocortisone West-Ward Pharmaceuticals Corp ANDA Current 0904-2674 Hydrocortisone Hydrocortisone Major Pharmaceuticals ANDA Current 43063-386 Hydrocortisone Hydrocortisone PD-Rx Pharmaceuticals, Inc. ANDA Current