Home NDC 42998-505 EMFLAZA
Product NDC 42998-505
11-digit product format 429980505
Labeler code 42998
Product ID 42998-505_4e001bac-ce04-4262-96f4-8b23161f9e55
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name deflazacort
Dosage form SUSPENSION
Route ORAL
Labeler Marathon Pharmaceuticals, LLC
Application NDA208685
Marketing category NDA
Marketing start 2017-02-09
Marketing end 2020-06-30
Substance DEFLAZACORT
Active strength 23 mg/mL
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
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 42998-505-21 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 42998-505-21 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 42998-505-21 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 42998-505-21 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 42998-505-21 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 42998-505-21 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 42998-505-21 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 42998-505-21 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 42998-505-21 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 42998-505-21 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 42998-505-21 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 42998-505-21 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 N208685-001 EMFLAZA DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N208685-001 AB
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208685-001 ODE-252 2026-06-07
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 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 92 observed states.
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 EMFLAZA DEFLAZACORT PTC Therapeutics, Inc. 31b347d2-f156-4055-9d8f-7cf0df420296 2025-11-13 Warnings, Adverse reactions Exact identifier application applno (NDA): 208685 application number: NDA208685