Tasimelteon
- Product NDC
- 69238-2548
- 11-digit product format
- 692382548
- Labeler code
- 69238
- Product ID
- 69238-2548_071804f4-9647-4a4d-a394-55b9e976dc9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tasimelteon
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA211654
- Marketing category
- ANDA
- Marketing start
- 2023-02-24
- Substance
- TASIMELTEON
- Active strength
- 20 mg/1
- Pharmacologic classes
- Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tasimelteon
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TASIMELTEON | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SHS4PU80D9 |
| Rxcui | 1490473 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-2548-3 | Tasimelteon | 30 in 1 BOTTLE | CAPSULE | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-2548 | TASIMELTEON CAPSULE [AMNEAL PHARMACEUTICALS NY LLC] | 7 | Current NDC, 1 package rows | 20230331_99cb1928-e57d-4d04-87a1-38108780598a.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 |
|---|
| 69238-2548-3 | 69238254803 | 30 CAPSULE in 1 BOTTLE (69238-2548-3) | 30 capsule | 2023-02-24 | No | No | Historical |