LISDEXAMFETAMINE DIMESYLATE
- Product NDC
- 57664-087
- 11-digit product format
- 576640087
- Labeler code
- 57664
- Product ID
- 57664-087_0b77417a-5789-8818-e063-6294a90ad2e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LISDEXAMFETAMINE DIMESYLATE
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA214134
- 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
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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 57664-087-88 | 57664008788 | 100 TABLET, CHEWABLE in 1 BOTTLE (57664-087-88) | 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 |