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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72893-015DDiscontinued by firm2026-08-03
excluded packagepackage72893-01572893-015-06DDiscontinued by firm2026-08-03
excluded packagepackage72893-01572893-015-24DDiscontinued by firm2026-08-03

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage72893-015-06557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage72893-015-24557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage72893-015-068af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage72893-015-248af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage72893-015-06834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage72893-015-24834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage72893-015-061332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage72893-015-241332a3947898…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N211379-001HEMADYDEXAMETHASONE20MGTABLET / ORALRLD, RS2019-10-03

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211379-001105375852037-12-18Drug product2020-01-23
N211379-001113049612037-12-18U-3344Drug product2022-04-19

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N211379-001ODE-2712026-10-03

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-0387673890dc5c…
2021-03-12 10:30 UTC2021-03N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-033f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-033f0d92c62455…
2023-05-13 08:27 UTC2023-05N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-03053a50430f4f…
2023-01-26 05:58 UTC2023-01N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-03cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N211379-001HEMADY20MGTABLET / ORALRLD, RS2019-10-03a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N211379-001105375852037-12-18Drug product2020-01-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211379-001113049612037-12-18U-3344Drug product2022-04-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211379-001105375852037-12-18Drug product2020-01-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211379-001113049612037-12-18U-3344Drug product2022-04-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N211379-001105375852037-12-18Drug product2020-01-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211379-001113049612037-12-18U-3344Drug product2022-04-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211379-001105375852037-12-18Drug product2020-01-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211379-001113049612037-12-18U-3344Drug product2022-04-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211379-001105375852037-12-18Drug product2020-01-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211379-001113049612037-12-18U-3344Drug product2022-04-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211379-001105375852037-12-18Drug product2020-01-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211379-001113049612037-12-18U-3344Drug product2022-04-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211379-001105375852037-12-18Drug product2020-01-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211379-001113049612037-12-18U-3344Drug product2022-04-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211379-001105375852037-12-18Drug product2020-01-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211379-001113049612037-12-18U-3344Drug product2022-04-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211379-001105375852037-12-18Drug product2020-01-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211379-001113049612037-12-18U-3344Drug product2022-04-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211379-001105375852037-12-18Drug product2020-01-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N211379-001113049612037-12-18U-3344Drug product2022-04-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211379-001105375852037-12-18Drug product2020-01-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211379-001113049612037-12-18U-3344Drug product2022-04-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211379-001105375852037-12-18Drug product2020-01-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211379-001113049612037-12-18U-3344Drug product2022-04-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211379-001105375852037-12-18Drug product2020-01-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211379-001113049612037-12-18U-3344Drug product2022-04-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211379-001105375852037-12-18Drug product2020-01-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05N211379-001113049612037-12-18U-3344Drug product2022-04-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211379-001105375852037-12-18Drug product2020-01-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211379-001113049612037-12-18U-3344Drug product2022-04-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N211379-001105375852037-12-18Drug product2020-01-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N211379-001105375852037-12-18Drug product2020-01-234b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N211379-001105375852037-12-18Drug product2020-01-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N211379-001105375852037-12-18Drug product2020-01-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N211379-001105375852037-12-18Drug product2020-01-2387673890dc5c…
2021-03-12 10:30 UTC2021-03N211379-001105375852037-12-18Drug product2020-01-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N211379-001105375852037-12-18Drug product2020-01-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N211379-001105375852037-12-18Drug product2020-01-23c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N211379-001105375852037-12-18Drug product2020-01-236a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N211379-001113049612037-12-18U-3344Drug product2022-04-196a51e52b5d6a…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N211379-001ODE-2712026-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211379-001ODE-2712026-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N211379-001ODE-2712026-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211379-001ODE-2712026-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211379-001ODE-2712026-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211379-001ODE-2712026-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211379-001ODE-2712026-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211379-001ODE-2712026-10-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211379-001ODE-2712026-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211379-001ODE-2712026-10-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211379-001ODE-2712026-10-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211379-001ODE-2712026-10-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211379-001ODE-2712026-10-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211379-001ODE-2712026-10-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211379-001ODE-2712026-10-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N211379-001ODE-2712026-10-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N211379-001ODE-2712026-10-034b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N211379-001ODE-2712026-10-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N211379-001ODE-2712026-10-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N211379-001ODE-2712026-10-0387673890dc5c…
2021-03-12 10:30 UTC2021-03N211379-001ODE-2712026-10-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N211379-001ODE-2712026-10-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11N211379-001ODE-2712026-10-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12N211379-001ODE-2712026-10-033f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N211379-001ODE-2712026-10-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N211379-001ODE-2712026-10-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12N211379-001ODE-2712026-10-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N211379-001ODE-2712026-10-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N211379-001ODE-2712026-10-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N211379-001ODE-2712026-10-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N211379-001ODE-2712026-10-033f0d92c62455…
2023-05-13 08:27 UTC2023-05N211379-001ODE-2712026-10-03053a50430f4f…
2023-01-26 05:58 UTC2023-01N211379-001ODE-2712026-10-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N211379-001ODE-2712026-10-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N211379-001ODE-2712026-10-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N211379-001ODE-2712026-10-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N211379-001ODE-2712026-10-03cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N211379-001ODE-2712026-10-03a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72893-015-06EA - Each72893-015a6a774bf-28be-411e-bc2a-b76d85d1f0dc12020-09-14
72893-015-24EA - Each72893-0154c6c5828-da6d-459f-9a5a-79e871146fb812020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72893-015HEMADY (DEXAMETHASONE) TABLET [ACROTECH BIOPHARMA INC]6Legacy NDC20240824_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HemadyDEXAMETHASONEEdenbridge Pharmaceuticals LLC.6b9cf32c-6d60-4853-bbfd-2304ffc2c1292026-01-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 211379
application number: NDA211379

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72893-015-0672893001506100 TABLET in 1 BOTTLE (72893-015-06) 100 tablet2020-06-110000-00-00NoNoCurrent
72893-015-247289300152424 TABLET in 1 BOTTLE (72893-015-24) 24 tablet2020-06-110000-00-00NoNoCurrent