Tasimelteon
- Product NDC
- 60505-4665
- 11-digit product format
- 605054665
- Labeler code
- 60505
- Product ID
- 60505-4665_5fdd9cbd-360f-3787-3863-c1172763840f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tasimelteon
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA211607
- Marketing category
- ANDA
- Marketing start
- 2024-01-05
- 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 |
|---|
| 60505-4665-3 | Tasimelteon | 30 in 1 BOTTLE | CAPSULE | 30 | | 2 |
| 60505-4665-9 | Tasimelteon | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-4665 | TASIMELTEON CAPSULE [APOTEX CORP.] | 2 | Current NDC, 2 package rows | 20250411_46b09064-a675-92d5-24a7-dac0410f77ae.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 |
|---|
| 60505-4665-3 | 60505466503 | 30 CAPSULE in 1 BOTTLE (60505-4665-3) | 30 capsule | 2024-01-05 | No | No | Historical |
| 60505-4665-9 | 60505466509 | 90 CAPSULE in 1 BOTTLE (60505-4665-9) | 90 capsule | 2024-01-05 | No | No | Historical |