EMFLAZA
- Product NDC
- 52856-502
- 11-digit product format
- 528560502
- Labeler code
- 52856
- Product ID
- 52856-502_604ae0b3-a373-40c0-b585-419abeac74eb
- 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
- 18 mg/1
- 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| Ingredient | Strength |
|---|
| DEFLAZACORT | 18 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KR5YZ6AE4B |
| Rxcui | 153098, 153880, 1870950, 1870952, 1870954, 1870956, 1870958, 1870960, 1870964, 1870968 |
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 |
|---|
| 52856-502-03 | 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 |
|---|
| 52856-502 | 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 |
|---|
| 52856-502-03 | 52856050203 | 30 TABLET in 1 BOTTLE (52856-502-03) | 30 tablet | 2018-09-10 | 0000-00-00 | No | No | Current |