Deflazacort
- Product NDC
- 0832-0816
- 11-digit product format
- 008320816
- Labeler code
- 0832
- Product ID
- 0832-0816_373dd14d-05b2-4408-e063-6394a90abf95
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Deflazacort
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- ANDA216720
- Marketing category
- ANDA
- Marketing start
- 2024-11-05
- Substance
- DEFLAZACORT
- Active strength
- 30 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
- Deflazacort
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEFLAZACORT | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KR5YZ6AE4B |
| Rxcui | 153098, 153880, 1870954, 1870958 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0832-0816-30 | Deflazacort | 1 in 1 CARTON | TABLET | 1 | | 6 |
| 0832-0816-30 | Deflazacort | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0832-0816 | DEFLAZACORT TABLET [UPSHER-SMITH LABORATORIES, LLC] | 4 | Current NDC, 2 package rows | 20250119_40818600-3ff0-4c9c-8e31-2001425a7dc9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0832-0816-30 | 00832081630 | 1 BOTTLE in 1 CARTON (0832-0816-30) / 30 TABLET in 1 BOTTLE | 1 bottle | 2025-01-17 | No | No | Current |