Prescription drug · NDA
Emflaza (Deflazacort) NDC 52856-504
Deflazacort 36 mg/1 · Tablet · Oral · PTC Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52856-504-03 | 5285605040352856050403 | 30 TABLET in 1 BOTTLE (52856-504-03)Marketed from Sep 10, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Emflaza
- Generic name (nonproprietary)
- deflazacort
- Active ingredients
- Deflazacort — 36 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PTC Therapeutics, Inc.NDC labeler code 52856
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208684
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 52856-504_2b07ec82-2eb4-4a87-9787-9c2db6a0649bSPL ID 2b07ec82-2eb4-4a87-9787-9c2db6a0649b
- Pharmacologic class
- Corticosteroid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N452856050403followed by a unit qualifier and the quantityPackage 52856-0504-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
The FDA listing for this product does not reference a label (SPL) set.
About NDC 52856-504
- What is NDC 52856-504?
- 52856-504 is the product NDC for Emflaza (deflazacort), Deflazacort 36 mg/1 tablet, listed with the FDA by PTC Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Emflaza (Deflazacort).
- What is the active ingredient?
- Deflazacort.
- Who is the labeler?
- PTC Therapeutics, Inc., NDC labeler code 52856. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Emflaza?
- 4 other product NDCs are listed under this name. See all Emflaza NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Emflaza products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Emflazadeflazacort | Deflazacort 6 mg/1 | TabletOral | PTC Therapeutics, Inc. | 52856-501 | 52856-0501-01 |
| Emflazadeflazacort | Deflazacort 18 mg/1 | TabletOral | PTC Therapeutics, Inc. | 52856-502 | 52856-0502-03 |
| Emflazadeflazacort | Deflazacort 30 mg/1 | TabletOral | PTC Therapeutics, Inc. | 52856-503 | 52856-0503-03 |
| Emflazadeflazacort | Deflazacort 22.75 mg/mL | SuspensionOral | PTC Therapeutics, Inc. | 52856-505 | 52856-0505-22 |
Other NDCs under NDA 208684
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Emflazadeflazacort | Deflazacort 6 mg/1 | TabletOral | PTC Therapeutics, Inc. | 52856-501 |
| Emflazadeflazacort | Deflazacort 18 mg/1 | TabletOral | PTC Therapeutics, Inc. | 52856-502 |
| Emflazadeflazacort | Deflazacort 30 mg/1 | TabletOral | PTC Therapeutics, Inc. | 52856-503 |