Home NDC 64239-300 HEMADY
Product NDC 64239-300
11-digit product format 642390300
Labeler code 64239
Product ID 64239-300_7cf0cc84-5689-4343-b3ef-92617406ee20
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexamethasone
Dosage form TABLET
Route ORAL
Labeler Dexcel Pharma Technologies Ltd.
Application NDA211379
Marketing category NDA
Marketing start 2020-03-31
Marketing end 0000-00-00
Substance DEXAMETHASONE
Active strength 20 mg/1
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64239-300-10 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64239-300-10 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64239-300-10 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64239-300-10 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64239-300-10 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64239-300-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64239-300-10 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64239-300-10 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64239-300-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64239-300-10 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64239-300-10 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64239-300-10 557ba5c1ecfa…9c80585c8c6e…
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 N211379-001 HEMADY DEXAMETHASONE 20MG TABLET / ORAL RLD, RS 2019-10-03
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211379-001 10537585 2037-12-18 Drug product 2020-01-23 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N211379-001 ODE-271 2026-10-03
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.
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 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 66 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19 6a51e52b5d6a…
Observed Orange Book exclusivity 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 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hemady DEXAMETHASONE Edenbridge Pharmaceuticals LLC. 6b9cf32c-6d60-4853-bbfd-2304ffc2c129 2026-01-09 Warnings, Adverse reactions Exact identifier application applno (NDA): 211379 application number: NDA211379