FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
EMFLAZA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEFLAZACORT22.75 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKR5YZ6AE4B
Rxcui153098, 153880, 1870950, 1870952, 1870954, 1870956, 1870958, 1870960, 1870964, 1870968

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52856-505-222023-02-21C16284748780-1f386c64a-34e5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EMFLAZA ® safely and effectively. See full prescribing information for EMFLAZA. EMFLAZA ® (deflazacort) tablets, for oral use EMFLAZA ® (deflazacort) oral suspension Initial U.S. Approval: 2017
52856-505-222023-01-30C16284748780-1f386c64a-34e5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EMFLAZA ® safely and effectively. See full prescribing information for EMFLAZA. EMFLAZA ® (deflazacort) tablets, for oral use EMFLAZA ® (deflazacort) oral suspension Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52856-505-22EMFLAZA13 mL in 1 BOTTLESUSPENSION1321

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52856-505-21ML - Milliliter52856-505508c9f04-ebaf-4598-bfa3-ae2cd45f20cf12018-10-11
52856-505-22ML - Milliliter52856-505d02f53f0-8c87-4230-b1d9-ef90beb1bfad12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52856-505EMFLAZA (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
52856-505-215285605052113 mL in 1 BOTTLE (52856-505-21) 13 ml2018-09-100000-00-00NoNoCurrent
52856-505-225285605052213 mL in 1 BOTTLE (52856-505-22) 13 ml2019-08-300000-00-00NoNoCurrent