Deflazacort
- Product NDC
- 0054-0827
- 11-digit product format
- 000540827
- Labeler code
- 0054
- Product ID
- 0054-0827_b019324e-dbd3-4404-a0b5-021d67c0270b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Deflazacort
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA220524
- Marketing category
- ANDA
- Marketing start
- 2026-10-07
- Substance
- DEFLAZACORT
- Active strength
- 36 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.
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
- Deflazacort
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEFLAZACORT | 36 mg/1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0054-0827-13 | 00054082713 | 30 TABLET in 1 BOTTLE (0054-0827-13) | 30 tablet | 2026-10-07 | No | No | Current |