Home NDC 52565-004-30 Hydrocortisone
Product NDC 52565-004
Requested package NDC 52565-004-30
11-digit product format 525650004
Labeler code 52565
Product ID 52565-004_4e850fa2-2bb2-4291-9b1d-6f03fcfcf15c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Teligent Pharma, Inc.
Application ANDA203810
Marketing category ANDA
Marketing start 2018-07-23
Marketing end 0000-00-00
Substance HYDROCORTISONE
Active strength 25 mg/g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 2018-07-23
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 · 41 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 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…2022-09-29 23:25 UTC 2022-09 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203810-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2018-07-23 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52565-004-26 Hydrocortisone 453.6 g in 1 JAR CREAM 453.6 3 52565-004-26 Hydrocortisone 1 in 1 CARTON CREAM 1 3 52565-004-30 Hydrocortisone 30 g in 1 TUBE CREAM 30 3 52565-004-30 Hydrocortisone 1 in 1 CARTON CREAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52565-004 HYDROCORTISONE CREAM [TELIGENT PHARMA, INC.] 3 Legacy NDC, 4 package rows 20190730_bc7651e9-e7c7-49e0-ad64-36eb50d3eaa2.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52565-004-30 52565000430 1 TUBE in 1 CARTON (52565-004-30) > 30 g in 1 TUBE 1 tube 2018-07-23 0000-00-00 No No Current