Prescription drug · ANDA
Deflazacort NDC 0832-0815
Deflazacort 18 mg/1 · Tablet · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0832-0815-30 | 00832081530 | 1 BOTTLE in 1 CARTON (0832-0815-30) / 30 TABLET in 1 BOTTLEMarketed from Jan 17, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Deflazacort
- Generic name (nonproprietary)
- deflazacort
- Active ingredients
- Deflazacort — 18 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216720
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0832-0815_55f5c3bf-2aa0-bd05-e063-6394a90ad3e6SPL ID 55f5c3bf-2aa0-bd05-e063-6394a90ad3e6SPL set ID 40818600-3ff0-4c9c-8e31-2001425a7dc9RxCUI 153098, 153880, 1870954, 1870958UNII KR5YZ6AE4B
- 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
N400832081530followed by a unit qualifier and the quantityPackage 00832-0815-30. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza ® (deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Deflazacort tablets are a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216720
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 |
|---|---|---|---|---|
| Deflazacort | Deflazacort 6 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-0814 |
| Deflazacort | Deflazacort 30 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-0816 |
| Deflazacort | Deflazacort 36 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-0817 |
| Kymbeedeflazacort | Deflazacort 6 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-0814 |
| Kymbeedeflazacort | Deflazacort 18 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-0815 |
| Kymbeedeflazacort | Deflazacort 30 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-0816 |
| Kymbeedeflazacort | Deflazacort 36 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-0817 |