Lisdexamfetamine Dimesylate
- Product NDC
- 0054-0375
- 11-digit product format
- 000540375
- Labeler code
- 0054
- Product ID
- 0054-0375_54a99322-a206-447c-b820-9e1b7e525816
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lisdexamfetamine dimesylate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA202827
- Marketing category
- ANDA
- Marketing start
- 2023-08-25
- Substance
- LISDEXAMFETAMINE DIMESYLATE
- Active strength
- 70 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | 70 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SJT761GEGS |
| Rxcui | 854830, 854834, 854838, 854842, 854846, 854850, 1593856 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0375-25 | Lisdexamfetamine Dimesylate | 100 in 1 BOTTLE | CAPSULE | 100 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0375 | LISDEXAMFETAMINE DIMESYLATE CAPSULE [HIKMA PHARMACEUTICALS USA INC.] | 5 | Current NDC, 1 package rows | 20250402_6740a621-9bec-4178-a4fc-a3fc89f34e0a.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 |
|---|
| 0054-0375-25 | 00054037525 | 100 CAPSULE in 1 BOTTLE (0054-0375-25) | 100 capsule | 2023-08-25 | No | No | Historical |