Tasimelteon
- Product NDC
- 0480-4490
- 11-digit product format
- 004804490
- Labeler code
- 0480
- Product ID
- 0480-4490_742d1ad6-c92e-4d2c-9d23-c5616751c5dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tasimelteon
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA211601
- Marketing category
- ANDA
- Marketing start
- 2022-12-29
- 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 |
|---|
| 0480-4490-56 | Tasimelteon | 30 in 1 BOTTLE | CAPSULE, GELATIN COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0480-4490 | TASIMELTEON CAPSULE, GELATIN COATED [TEVA PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250205_ce5a2fa3-ed54-422d-96c2-1821496eb32f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0480-4490-56 | 00480449056 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-4490-56) | 2022-12-29 | 0000-00-00 | No | No | Current |