Home NDC 52856-505 EMFLAZA
Product NDC 52856-505
11-digit product format 528560505
Labeler code 52856
Product ID 52856-505_604ae0b3-a373-40c0-b585-419abeac74eb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name deflazacort
Dosage form SUSPENSION
Route ORAL
Labeler PTC Therapeutics, Inc.
Application NDA208685
Marketing category NDA
Marketing start 2018-09-10
Substance DEFLAZACORT
Active strength 22.75 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base EMFLAZA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEFLAZACORT 22.75 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KR5YZ6AE4B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 153098 Internal RxNorm lookup 153880 Internal RxNorm lookup 1870950 Internal RxNorm lookup 1870952 Internal RxNorm lookup 1870954 Internal RxNorm lookup 1870956 Internal RxNorm lookup 1870958 Internal RxNorm lookup 1870960 Internal RxNorm lookup 1870964 Internal RxNorm lookup 1870968 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52856-505-22 EMFLAZA 13 mL in 1 BOTTLE SUSPENSION 13 21
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52856-505 EMFLAZA (DEFLAZACORT) TABLET EMFLAZA (DEFLAZACORT) SUSPENSION [PTC THERAPEUTICS, INC.] 20 Current NDC, Legacy NDC, 1 package rows 20241220_31b347d2-f156-4055-9d8f-7cf0df420296.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 Marketing end Sample Exclude flag Status 52856-505-21 52856050521 13 mL in 1 BOTTLE (52856-505-21) 13 ml 2018-09-10 0000-00-00 No No Current 52856-505-22 52856050522 13 mL in 1 BOTTLE (52856-505-22) 13 ml 2019-08-30 0000-00-00 No No Current