Home NDC 52856-503 EMFLAZA
Product NDC 52856-503
11-digit product format 528560503
Labeler code 52856
Product ID 52856-503_2b07ec82-2eb4-4a87-9787-9c2db6a0649b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name deflazacort
Dosage form TABLET
Route ORAL
Labeler PTC Therapeutics, Inc.
Application NDA208684
Marketing category NDA
Marketing start 2018-09-10
Substance DEFLAZACORT
Active strength 30 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 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208684-001 EMFLAZA DEFLAZACORT 6MG TABLET / ORAL AB RLD 2017-02-09 N208684-002 EMFLAZA DEFLAZACORT 18MG TABLET / ORAL AB RLD 2017-02-09 N208684-003 EMFLAZA DEFLAZACORT 30MG TABLET / ORAL AB RLD 2017-02-09 N208684-004 EMFLAZA DEFLAZACORT 36MG TABLET / ORAL AB RLD, RS 2017-02-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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 5 · 176 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 2026-10-15 13:18:30 2026-09 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 c2088c7a36db…2026-09-14 22:38:34 2026-08 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 9 of 10 · 380 observed states.
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 EMFLAZA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEFLAZACORT 30 mg/1
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 52856-503-03 EMFLAZA 30 in 1 BOTTLE TABLET 30 21
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52856-503 EMFLAZA (DEFLAZACORT) TABLET EMFLAZA (DEFLAZACORT) SUSPENSION [PTC THERAPEUTICS, INC.] 20 Current NDC, Legacy NDC, 1 package rows 20241220_31b347d2-f156-4055-9d8f-7cf0df420296.zip
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 52856-503-03 52856050303 30 TABLET in 1 BOTTLE (52856-503-03) 30 tablet 2018-09-10 0000-00-00 No No Current