LISDEXAMFETAMINE DIMESYLATE
- Product NDC
- 57664-050
- 11-digit product format
- 576640050
- Labeler code
- 57664
- Product ID
- 57664-050_0b77417a-5789-8818-e063-6294a90ad2e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LISDEXAMFETAMINE DIMESYLATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA214484
- Marketing category
- ANDA
- Marketing start
- 2023-08-25
- Substance
- LISDEXAMFETAMINE DIMESYLATE
- Active strength
- 50 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
openFDA Listing Details
- Product ID
- 57664-050_0b77417a-5789-8818-e063-6294a90ad2e3
- SPL ID
- 0b77417a-5789-8818-e063-6294a90ad2e3
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- LISDEXAMFETAMINE DIMESYLATE
- Generic name
- LISDEXAMFETAMINE DIMESYLATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing start
- 2023-08-25
- Marketing category
- ANDA
- Application number
- ANDA214484
- Pharmacologic classes
- Central Nervous System Stimulant [EPC]; Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| LISDEXAMFETAMINE DIMESYLATE | 50 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | SJT761GEGS |
| Rxcui | 854830, 854834, 854838, 854842, 854846, 854850, 1593856, 1871456, 1871460, 1871462, 1871464, 1871466, 1871468 |
| Spl Set Id | da3148af-f9b6-4725-adae-3595b4c7dc4b |
| Manufacturer Name | Sun Pharmaceutical Industries, Inc. |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 57664-050-88 | 100 CAPSULE in 1 BOTTLE (57664-050-88) | 2023-08-25 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| SJT761GEGS | LISDEXAMFETAMINE DIMESYLATE | 608137-33-3 | LISDEXAMFETAMINE DIMESYLATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 57664-050-88 | 57664005088 | 100 CAPSULE in 1 BOTTLE (57664-050-88) | 100 capsule | 2023-08-25 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| LISDEXAMFETAMINE DIMESYLATE | Sun Pharmaceutical Industries, Inc. | Ohm Laboratories Inc. | 2023-12-01 | HUMAN PRESCRIPTION DRUG LABEL | 8 |