Dexamethasone
- Product NDC
- 69452-278
- 11-digit product format
- 694520278
- Labeler code
- 69452
- Product ID
- 69452-278_2f9dcbaf-165e-5594-e063-6394a90a9dc5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexamethasone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bionpharma Inc.,
- Application
- ANDA217001
- Marketing category
- ANDA
- Marketing start
- 2023-08-01
- Substance
- DEXAMETHASONE
- Active strength
- 6 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 | 6 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7S5I7G3JQL |
| Rxcui | 197582, 197583 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69452-278-20 | Dexamethasone | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-278 | DEXAMETHASONE TABLET [BIONPHARMA INC.,] | 3 | Current NDC, 1 package rows | 20250308_3166db4f-66a5-496a-a194-3cc01b7347d3.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 |
|---|
| 69452-278-20 | 69452027820 | 100 TABLET in 1 BOTTLE (69452-278-20) | 100 tablet | 2023-08-01 | No | No | Current |