Deflazacort Oral Suspension
- Product NDC
- 27808-249
- 11-digit product format
- 278080249
- Labeler code
- 27808
- Product ID
- 27808-249_efc7fb53-ed0f-4ec1-a6ce-dee55f0064d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Deflazacort Oral
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Cranbury Pharmaceuticals, LLC
- Application
- ANDA217813
- Marketing category
- ANDA
- Marketing start
- 2024-05-01
- Substance
- DEFLAZACORT
- Active strength
- 22.75 mg/mL
- 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 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 27808-249-01 | Deflazacort Oral Suspension | 13 mL in 1 BOTTLE | SUSPENSION | 13 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27808-249 | DEFLAZACORT ORAL SUSPENSION (DEFLAZACORT ORAL) SUSPENSION [TRIS PHARMA INC] | 7 | Current NDC, 1 package rows | 20240726_881785a5-41b4-4679-a29b-5d77ca51ca60.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 |
|---|
| 27808-249-01 | 27808024901 | 13 mL in 1 BOTTLE (27808-249-01) | 13 ml | 2024-05-01 | No | No | Current |