Home NDC 21922-065-05 Hydrocortisone
Product NDC 21922-065
Requested package NDC 21922-065-05
11-digit product format 219220065
Labeler code 21922
Product ID 21922-065_54e97533-1b55-4a7a-b888-8f6b192ab357
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA203810
Marketing category ANDA
Marketing start 2026-06-27
Substance HYDROCORTISONE
Active strength 25 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 A203810-001 HYDROCORTISONE HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2018-07-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203810-001 AT
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 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2018-07-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2018-07-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2018-07-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2018-07-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2018-07-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2018-07-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2018-07-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Hydrocortisone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 25 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310891 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 21922-065-05 21922006505 1 TUBE in 1 CARTON (21922-065-05) / 30 g in 1 TUBE 1 tube 2026-06-27 No No Current