Dexamethasone
- Product NDC
- 70954-399
- 11-digit product format
- 709540399
- Labeler code
- 70954
- Product ID
- 70954-399_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
- 2023-10-09
- Substance
- DEXAMETHASONE
- Active strength
- .75 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 | .75 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 |
|---|
| 70954-399-10 | Dexamethasone | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-399 | DEXAMETHASONE TABLET [ANI PHARMACEUTICALS, INC.] | 5 | Current NDC, 1 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 | Sample | Exclude flag | Status |
|---|
| 70954-399-10 | 70954039910 | 100 TABLET in 1 BOTTLE (70954-399-10) | 100 tablet | 2023-10-09 | No | No | Historical |