Dexamethasone
- Product NDC
- 68788-8824
- 11-digit product format
- 687888824
- Labeler code
- 68788
- Product ID
- 68788-8824_b883860c-27ba-4bac-8ae3-4cf4d82d5071
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexamethasone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA217001
- Marketing category
- ANDA
- Marketing start
- 2025-02-10
- Substance
- DEXAMETHASONE
- Active strength
- 4 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
- Dexamethasone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXAMETHASONE | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7S5I7G3JQL |
| Rxcui | 197582 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8824-1 | 68788882401 | 12 TABLET in 1 BOTTLE (68788-8824-1) | 12 tablet | 2025-02-10 | No | No | Historical |
| 68788-8824-3 | 68788882403 | 30 TABLET in 1 BOTTLE (68788-8824-3) | 30 tablet | 2025-02-10 | No | No | Historical |
| 68788-8824-5 | 68788882405 | 15 TABLET in 1 BOTTLE (68788-8824-5) | 15 tablet | 2025-02-10 | No | No | Historical |
| 68788-8824-6 | 68788882406 | 6 TABLET in 1 BOTTLE (68788-8824-6) | 6 tablet | 2025-02-10 | No | No | Historical |