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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208684-001EMFLAZADEFLAZACORT6MGTABLET / ORALABRLD2017-02-09
N208684-002EMFLAZADEFLAZACORT18MGTABLET / ORALABRLD2017-02-09
N208684-003EMFLAZADEFLAZACORT30MGTABLET / ORALABRLD2017-02-09
N208684-004EMFLAZADEFLAZACORT36MGTABLET / ORALABRLD, RS2017-02-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N208684-001AB
N208684-002AB
N208684-003AB
N208684-004AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N208684-001ODE-2522026-06-07
N208684-002ODE-2522026-06-07
N208684-003ODE-2522026-06-07
N208684-004ODE-2522026-06-07

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 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N208684-001EMFLAZA6MGTABLET / ORALABRLD2017-02-09c2088c7a36db…
2026-10-15 13:18:302026-09N208684-002EMFLAZA18MGTABLET / ORALABRLD2017-02-09c2088c7a36db…
2026-10-15 13:18:302026-09N208684-003EMFLAZA30MGTABLET / ORALABRLD2017-02-09c2088c7a36db…
2026-10-15 13:18:302026-09N208684-004EMFLAZA36MGTABLET / ORALABRLD, RS2017-02-09c2088c7a36db…
2026-09-14 22:38:342026-08N208684-001EMFLAZA6MGTABLET / ORALABRLD2017-02-0984e616aacf4f…
2026-09-14 22:38:342026-08N208684-002EMFLAZA18MGTABLET / ORALABRLD2017-02-0984e616aacf4f…
2026-09-14 22:38:342026-08N208684-003EMFLAZA30MGTABLET / ORALABRLD2017-02-0984e616aacf4f…
2026-09-14 22:38:342026-08N208684-004EMFLAZA36MGTABLET / ORALABRLD, RS2017-02-0984e616aacf4f…
2026-08-18 06:07:402026-07N208684-001EMFLAZA6MGTABLET / ORALABRLD2017-02-09caaa826d4ba7…
2026-08-18 06:07:402026-07N208684-002EMFLAZA18MGTABLET / ORALABRLD2017-02-09caaa826d4ba7…
2026-08-18 06:07:402026-07N208684-003EMFLAZA30MGTABLET / ORALABRLD2017-02-09caaa826d4ba7…
2026-08-18 06:07:402026-07N208684-004EMFLAZA36MGTABLET / ORALABRLD, RS2017-02-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208684-001EMFLAZA6MGTABLET / ORALABRLD2017-02-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208684-002EMFLAZA18MGTABLET / ORALABRLD2017-02-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208684-003EMFLAZA30MGTABLET / ORALABRLD2017-02-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208684-004EMFLAZA36MGTABLET / ORALABRLD, RS2017-02-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208684-001EMFLAZA6MGTABLET / ORALABRLD2017-02-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208684-002EMFLAZA18MGTABLET / ORALABRLD2017-02-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208684-003EMFLAZA30MGTABLET / ORALABRLD2017-02-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208684-004EMFLAZA36MGTABLET / ORALABRLD, RS2017-02-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N208684-001EMFLAZA6MGTABLET / ORALABRLD2017-02-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208684-002EMFLAZA18MGTABLET / ORALABRLD2017-02-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208684-003EMFLAZA30MGTABLET / ORALABRLD2017-02-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208684-004EMFLAZA36MGTABLET / ORALABRLD, RS2017-02-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208684-001EMFLAZA6MGTABLET / ORALABRLD2017-02-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208684-002EMFLAZA18MGTABLET / ORALABRLD2017-02-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208684-003EMFLAZA30MGTABLET / ORALABRLD2017-02-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208684-004EMFLAZA36MGTABLET / ORALABRLD, RS2017-02-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208684-001EMFLAZA6MGTABLET / ORALABRLD2017-02-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208684-002EMFLAZA18MGTABLET / ORALABRLD2017-02-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208684-003EMFLAZA30MGTABLET / ORALABRLD2017-02-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208684-004EMFLAZA36MGTABLET / ORALABRLD, RS2017-02-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208684-001EMFLAZA6MGTABLET / ORALABRLD2017-02-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208684-002EMFLAZA18MGTABLET / ORALABRLD2017-02-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208684-003EMFLAZA30MGTABLET / ORALABRLD2017-02-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208684-004EMFLAZA36MGTABLET / ORALABRLD, RS2017-02-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208684-001EMFLAZA6MGTABLET / ORALABRLD2017-02-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208684-002EMFLAZA18MGTABLET / ORALABRLD2017-02-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208684-003EMFLAZA30MGTABLET / ORALABRLD2017-02-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208684-004EMFLAZA36MGTABLET / ORALABRLD, RS2017-02-092680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N208684-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09N208684-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09N208684-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09N208684-004AB1c2088c7a36db…
2026-09-14 22:38:342026-08N208684-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N208684-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N208684-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N208684-004AB184e616aacf4f…
2026-08-18 06:07:402026-07N208684-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N208684-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N208684-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N208684-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208684-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208684-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208684-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208684-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208684-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208684-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208684-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208684-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N208684-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208684-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208684-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208684-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208684-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208684-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208684-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208684-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208684-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208684-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208684-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208684-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208684-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208684-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208684-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208684-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208684-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208684-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208684-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208684-004AB12680178bc6a6…

Observed Orange Book exclusivity history#

Exclusivity history page 9 of 10 · 380 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2023-01-26 05:58 UTC2023-01N208684-002ODE-1302024-02-093bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N208684-002ODE-2522026-06-073bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N208684-003NCE2022-02-093bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N208684-003ODE-1302024-02-093bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N208684-003ODE-2522026-06-073bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N208684-004NCE2022-02-093bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N208684-004ODE-1302024-02-093bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N208684-004ODE-2522026-06-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208684-001NCE2022-02-093a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208684-001ODE-1302024-02-093a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208684-001ODE-2522026-06-073a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208684-002NCE2022-02-093a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208684-002ODE-1302024-02-093a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208684-002ODE-2522026-06-073a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208684-003NCE2022-02-093a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208684-003ODE-1302024-02-093a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208684-003ODE-2522026-06-073a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208684-004NCE2022-02-093a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208684-004ODE-1302024-02-093a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208684-004ODE-2522026-06-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208684-001NCE2022-02-09f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N208684-001ODE-1302024-02-09f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N208684-001ODE-2522026-06-07f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N208684-002NCE2022-02-09f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N208684-002ODE-1302024-02-09f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N208684-002ODE-2522026-06-07f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N208684-003NCE2022-02-09f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N208684-003ODE-1302024-02-09f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N208684-003ODE-2522026-06-07f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N208684-004NCE2022-02-09f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N208684-004ODE-1302024-02-09f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N208684-004ODE-2522026-06-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208684-001NCE2022-02-09e64feba35796…
2022-09-29 23:25 UTC2022-09N208684-001ODE-1302024-02-09e64feba35796…
2022-09-29 23:25 UTC2022-09N208684-001ODE-2522026-06-07e64feba35796…
2022-09-29 23:25 UTC2022-09N208684-002NCE2022-02-09e64feba35796…
2022-09-29 23:25 UTC2022-09N208684-002ODE-1302024-02-09e64feba35796…
2022-09-29 23:25 UTC2022-09N208684-002ODE-2522026-06-07e64feba35796…
2022-09-29 23:25 UTC2022-09N208684-003NCE2022-02-09e64feba35796…
2022-09-29 23:25 UTC2022-09N208684-003ODE-1302024-02-09e64feba35796…

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
IngredientStrength
DEFLAZACORT30 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
890642af-0787-4d04-9130-a3ba5909cd85Product name520260106
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52856-503-03EMFLAZA30 in 1 BOTTLETABLET3021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52856-503-03EA - Each52856-503116cc16d-3a0e-4136-8a74-f9c4d5dba36912018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52856-503EMFLAZA (DEFLAZACORT) TABLET EMFLAZA (DEFLAZACORT) SUSPENSION [PTC THERAPEUTICS, INC.]20Current NDC, Legacy NDC, 1 package rows20241220_31b347d2-f156-4055-9d8f-7cf0df420296.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870954deflazacort 18 MG Oral TabletPSN31b347d2-f156-4055-9d8f-7cf0df42029621
1870964deflazacort 22.75 MG/mL Oral SuspensionPSN31b347d2-f156-4055-9d8f-7cf0df42029621
153880deflazacort 30 MG Oral TabletPSN31b347d2-f156-4055-9d8f-7cf0df42029621
1870958deflazacort 36 MG Oral TabletPSN31b347d2-f156-4055-9d8f-7cf0df42029621
153098deflazacort 6 MG Oral TabletPSN31b347d2-f156-4055-9d8f-7cf0df42029621
1870956Emflaza 18 MG Oral TabletPSN31b347d2-f156-4055-9d8f-7cf0df42029621
1870968Emflaza 22.75 MG/mL Oral SuspensionPSN31b347d2-f156-4055-9d8f-7cf0df42029621
1870952Emflaza 30 MG Oral TabletPSN31b347d2-f156-4055-9d8f-7cf0df42029621
1870960Emflaza 36 MG Oral TabletPSN31b347d2-f156-4055-9d8f-7cf0df42029621
1870950Emflaza 6 MG Oral TabletPSN31b347d2-f156-4055-9d8f-7cf0df42029621
1870956deflazacort 18 MG Oral Tablet [Emflaza]SBD31b347d2-f156-4055-9d8f-7cf0df42029621
1870968deflazacort 22.75 MG/ML Oral Suspension [Emflaza]SBD31b347d2-f156-4055-9d8f-7cf0df42029621
1870952deflazacort 30 MG Oral Tablet [Emflaza]SBD31b347d2-f156-4055-9d8f-7cf0df42029621
1870960deflazacort 36 MG Oral Tablet [Emflaza]SBD31b347d2-f156-4055-9d8f-7cf0df42029621
1870950deflazacort 6 MG Oral Tablet [Emflaza]SBD31b347d2-f156-4055-9d8f-7cf0df42029621
1870954deflazacort 18 MG Oral TabletSCD31b347d2-f156-4055-9d8f-7cf0df42029621
1870964deflazacort 22.75 MG/ML Oral SuspensionSCD31b347d2-f156-4055-9d8f-7cf0df42029621
153880deflazacort 30 MG Oral TabletSCD31b347d2-f156-4055-9d8f-7cf0df42029621
1870958deflazacort 36 MG Oral TabletSCD31b347d2-f156-4055-9d8f-7cf0df42029621
153098deflazacort 6 MG Oral TabletSCD31b347d2-f156-4055-9d8f-7cf0df42029621
1870956Emflaza 18 MG Oral TabletSY31b347d2-f156-4055-9d8f-7cf0df42029621
1870968Emflaza 22.75 MG/ML Oral SuspensionSY31b347d2-f156-4055-9d8f-7cf0df42029621
1870952Emflaza 30 MG Oral TabletSY31b347d2-f156-4055-9d8f-7cf0df42029621
1870960Emflaza 36 MG Oral TabletSY31b347d2-f156-4055-9d8f-7cf0df42029621
1870950Emflaza 6 MG Oral TabletSY31b347d2-f156-4055-9d8f-7cf0df42029621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52856-503-035285605030330 TABLET in 1 BOTTLE (52856-503-03) 30 tablet2018-09-100000-00-00NoNoCurrent