Home NDC 72893-015 Hemady
Product NDC 72893-015
11-digit product format 728930015
Labeler code 72893
Product ID 72893-015_081a2f2e-dbdc-4e99-99c1-c2e911ba7709
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexamethasone
Dosage form TABLET
Route ORAL
Labeler Acrotech Biopharma LLC
Application NDA211379
Marketing category NDA
Marketing start 2020-06-11
Marketing end 0000-00-00
Substance DEXAMETHASONE
Active strength 20 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 12 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 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 72893-015-06 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 72893-015-24 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 72893-015-06 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 72893-015-24 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 72893-015-06 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 72893-015-24 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 72893-015-06 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 72893-015-24 1332a3947898…d4bfe170f9cd…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72893-015 HEMADY (DEXAMETHASONE) TABLET [ACROTECH BIOPHARMA INC] 6 Legacy NDC 20240824_aec60743-f925-4d91-a865-064696a9f9e6.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.
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72893-015-06 72893001506 100 TABLET in 1 BOTTLE (72893-015-06) 100 tablet 2020-06-11 0000-00-00 No No Current 72893-015-24 72893001524 24 TABLET in 1 BOTTLE (72893-015-24) 24 tablet 2020-06-11 0000-00-00 No No Current