Lisdexamfetamine Dimesylate
- Product NDC
- 65162-024
- 11-digit product format
- 651620024
- Labeler code
- 65162
- Product ID
- 65162-024_ba9f3370-3096-4d8c-9571-e28faf54291f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lisdexamfetamine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA202830
- Marketing category
- ANDA
- Marketing start
- 2023-08-28
- Substance
- LISDEXAMFETAMINE DIMESYLATE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lisdexamfetamine Dimesylate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LISDEXAMFETAMINE DIMESYLATE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SJT761GEGS |
| Rxcui | 854830, 854834, 854838, 854842, 854846, 854850 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-024-09 | Lisdexamfetamine Dimesylate | 90 in 1 BOTTLE | CAPSULE | 90 | | 22 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-024 | LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE) CAPSULE [AMNEAL PHARMACEUTICALS LLC] | 19 | Current NDC, 1 package rows | 20250216_c11cb3b6-3dff-477b-a249-b4c3118edc5f.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 |
|---|
| 65162-024-09 | 65162002409 | 90 CAPSULE in 1 BOTTLE (65162-024-09) | 90 capsule | 2023-08-28 | No | No | Current |