Deflazacort Oral Suspension
- Product NDC
- 57664-993
- 11-digit product format
- 576640993
- Labeler code
- 57664
- Product ID
- 57664-993_4962347e-353c-558e-e063-6394a90a6861
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Deflazacort Oral
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA219930
- Marketing category
- ANDA
- Marketing start
- 2026-02-02
- Substance
- DEFLAZACORT
- Active strength
- 22.75 mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Deflazacort Oral Suspension
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEFLAZACORT | 22.75 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KR5YZ6AE4B |
| Rxcui | 1870964 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57664-993-01 | Deflazacort Oral Suspension | 13 mL in 1 BOTTLE | SUSPENSION | 13 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 57664-993-01 | 57664099301 | 13 mL in 1 BOTTLE (57664-993-01) | 13 ml | 2026-02-02 | No | No | Current |