ARYNTA
- Product NDC
- 24338-162
- 11-digit product format
- 243380162
- Labeler code
- 24338
- Product ID
- 24338-162_ac355447-df74-4bb1-b0b6-1869a4846309
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lisdexamfetamine dimesylate oral
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Azurity Pharmaceuticals, Inc.
- Application
- NDA219847
- Marketing category
- NDA
- Marketing start
- 2026-03-20
- Substance
- LISDEXAMFETAMINE DIMESYLATE
- Active strength
- 10 mg/mL
- 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
- ARYNTA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LISDEXAMFETAMINE DIMESYLATE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SJT761GEGS |
| Rxcui | 2726048, 2726055 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 24338-162-01 | ARYNTA | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 4 |
| 24338-162-01 | ARYNTA | 1 in 1 CARTON | SOLUTION | 1 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 24338-162-01 | 24338016201 | 1 BOTTLE in 1 CARTON (24338-162-01) / 120 mL in 1 BOTTLE | 1 bottle | 2026-03-20 | No | No | Current |