Dexamethasone
- Product NDC
- 70954-403
- 11-digit product format
- 709540403
- Labeler code
- 70954
- Product ID
- 70954-403_75141974-8862-4da7-9253-a338cb1fdb84
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexamethasone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA215604
- Marketing category
- ANDA
- Marketing start
- 2022-08-08
- 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 | 197577, 197580, 197581, 197582, 197583, 343033 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-403-10 | Dexamethasone | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 70954-403-20 | Dexamethasone | 1 in 1 BLISTER PACK | TABLET | 1 | | 5 |
| 70954-403-30 | Dexamethasone | 100 in 1 CARTON | TABLET | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-403 | DEXAMETHASONE TABLET [ANI PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 3 package rows | 20240305_fe8cf911-84ef-47be-acb8-0501b546299b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70954-403-10 | 70954040310 | 100 TABLET in 1 BOTTLE (70954-403-10) | 100 tablet | 2022-08-08 | 0000-00-00 | No | No | Current |
| 70954-403-20 | 70954040320 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 70954-403-30 | 70954040330 | 100 BLISTER PACK in 1 CARTON (70954-403-30) / 1 TABLET in 1 BLISTER PACK (70954-403-20) | 100 blister pack | 2022-08-08 | 0000-00-00 | No | No | Current |