Home NDC 82111-955-01 Hemady
Product NDC 82111-955
Requested package NDC 82111-955-01
11-digit product format 821110955
Labeler code 82111
Product ID 82111-955_d3488fd8-88b2-4f73-9fa4-fbcf14ddd972
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dexamethasone
Dosage form TABLET
Route ORAL
Labeler Edenbridge Pharmaceuticals LLC.
Application NDA211379
Marketing category NDA
Marketing start 2019-10-03
Substance DEXAMETHASONE
Active strength 20 mg/1
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 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.
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 2026-09-14 22:38:34 2026-08 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211379-001 HEMADY 20MG TABLET / ORAL RLD, RS 2019-10-03 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 2 · 70 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211379-001 10537585 2037-12-18 Drug product 2020-01-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211379-001 11304961 2037-12-18 U-3344 Drug product 2022-04-19 caaa826d4ba7…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…
Observed Orange Book exclusivity 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 Hemady
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXAMETHASONE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7S5I7G3JQL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2261802 Internal RxNorm lookup 2286261 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82111-955-01 Hemady 24 in 1 BOTTLE TABLET 24 4 82111-955-01 Hemady 1 in 1 CARTON TABLET 1 4 82111-955-02 Hemady 1 in 1 CARTON TABLET 1 4 82111-955-02 Hemady 100 in 1 BOTTLE TABLET 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82111-955 HEMADY (DEXAMETHASONE) TABLET [EDENBRIDGE PHARMACEUTICALS LLC.] 3 Current NDC, 4 package rows 20240606_6b9cf32c-6d60-4853-bbfd-2304ffc2c129.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 Sample Exclude flag Status 82111-955-01 82111095501 1 BOTTLE in 1 CARTON (82111-955-01) / 24 TABLET in 1 BOTTLE 1 bottle 2023-12-01 No No Current