Lisdexamfetamine Dimesylate
- Product NDC
- 42291-041
- 11-digit product format
- 422910041
- Labeler code
- 42291
- Product ID
- 42291-041_36c401bd-e228-6fbd-e063-6394a90a5f1f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lisdexamfetamine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA202830
- Marketing category
- ANDA
- Marketing start
- 2025-06-04
- 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
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LISDEXAMFETAMINE DIMESYLATE | 70 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | SJT761GEGS |
| Rxcui | 854830, 854834, 854838, 854842, 854846, 854850 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cb29ac3a-860f-7ed2-7559-c97af4af1704 | Product name | 3 | 20250603 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42291-041-90 | Lisdexamfetamine Dimesylate | 90 in 1 BOTTLE | CAPSULE | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42291-041-90 | EA - Each | 42291-041 | e9566204-a511-48e5-a9df-f90639856ac1 | 1 | 2025-07-08 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 854830 | lisdexamfetamine dimesylate 20 MG Oral Capsule | PSN | 36c40404-fe94-6fb7-e063-6394a90a2657 | 1 |
| 854834 | lisdexamfetamine dimesylate 30 MG Oral Capsule | PSN | 36c40404-fe94-6fb7-e063-6394a90a2657 | 1 |
| 854838 | lisdexamfetamine dimesylate 40 MG Oral Capsule | PSN | 36c40404-fe94-6fb7-e063-6394a90a2657 | 1 |
| 854850 | lisdexamfetamine dimesylate 50 MG Oral Capsule | PSN | 36c40404-fe94-6fb7-e063-6394a90a2657 | 1 |
| 854846 | lisdexamfetamine dimesylate 60 MG Oral Capsule | PSN | 36c40404-fe94-6fb7-e063-6394a90a2657 | 1 |
| 854842 | lisdexamfetamine dimesylate 70 MG Oral Capsule | PSN | 36c40404-fe94-6fb7-e063-6394a90a2657 | 1 |
| 854830 | lisdexamfetamine dimesylate 20 MG Oral Capsule | SCD | 36c40404-fe94-6fb7-e063-6394a90a2657 | 1 |
| 854834 | lisdexamfetamine dimesylate 30 MG Oral Capsule | SCD | 36c40404-fe94-6fb7-e063-6394a90a2657 | 1 |
| 854838 | lisdexamfetamine dimesylate 40 MG Oral Capsule | SCD | 36c40404-fe94-6fb7-e063-6394a90a2657 | 1 |
| 854850 | lisdexamfetamine dimesylate 50 MG Oral Capsule | SCD | 36c40404-fe94-6fb7-e063-6394a90a2657 | 1 |
| 854846 | lisdexamfetamine dimesylate 60 MG Oral Capsule | SCD | 36c40404-fe94-6fb7-e063-6394a90a2657 | 1 |
| 854842 | lisdexamfetamine dimesylate 70 MG Oral Capsule | SCD | 36c40404-fe94-6fb7-e063-6394a90a2657 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42291-041-90 | 42291004190 | 90 CAPSULE in 1 BOTTLE (42291-041-90) | 90 capsule | 2025-06-04 | No | No | Current |