LISDEXAMFETAMINE DIMESYLATE
- Product NDC
- 31722-350
- 11-digit product format
- 317220350
- Labeler code
- 31722
- Product ID
- 31722-350_c797bf2e-e9b6-4f7f-b12c-c514667107f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lisdexamfetamine dimesylate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA217442
- Marketing category
- ANDA
- Marketing start
- 2024-09-09
- Substance
- LISDEXAMFETAMINE DIMESYLATE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SJT761GEGS |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-350-01 | LISDEXAMFETAMINE DIMESYLATE | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-350 | LISDEXAMFETAMINE DIMESYLATE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20240925_20baa61e-be0b-41a3-a896-29e8ce8c4799.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 |
|---|
| 31722-350-01 | 31722035001 | 100 CAPSULE in 1 BOTTLE (31722-350-01) | 100 capsule | 2024-09-09 | No | No | Current |