Dexamethasone
- Product NDC
- 10135-795
- 11-digit product format
- 101350795
- Labeler code
- 10135
- Product ID
- 10135-795_59cae836-8f84-4276-9289-73ae101b8ddf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexamethasone
- Dosage form
- ELIXIR
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc
- Application
- ANDA084754
- Marketing category
- ANDA
- Marketing start
- 1976-09-21
- Substance
- DEXAMETHASONE
- Active strength
- .5 mg/5mL
- 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 | .5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7S5I7G3JQL |
| Rxcui | 309686 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-795-71 | Dexamethasone | 237 mL in 1 BOTTLE, GLASS | ELIXIR | 237 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-795 | DEXAMETHASONE ELIXIR [MARLEX PHARMACEUTICALS, INC] | 1 | Current NDC, 1 package rows | 20250504_7b51ffce-ec64-4b49-8870-b9666537c541.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 |
|---|
| 10135-795-71 | 10135079571 | 237 mL in 1 BOTTLE, GLASS (10135-795-71) | 237 ml | 1976-09-21 | No | No | Current |