lisdexamfetamine dimesylate
- Product NDC
- 0480-9742
- 11-digit product format
- 004809742
- Labeler code
- 0480
- Product ID
- 0480-9742_a9418850-010a-4fff-9aa7-d7167d58d8b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lisdexamfetamine dimesylate
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA215415
- Marketing category
- ANDA
- Marketing start
- 2024-09-16
- 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
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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SJT761GEGS |
| Rxcui | 1871456, 1871460, 1871462, 1871464, 1871466, 1871468 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0480-9742-01 | lisdexamfetamine dimesylate | 100 in 1 BOTTLE | TABLET, CHEWABLE | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0480-9742 | LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE [TEVA PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20240918_bdb03bfa-0398-41e5-8e73-ded696cbca32.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0480-9742-01 | 00480974201 | 100 TABLET, CHEWABLE in 1 BOTTLE (0480-9742-01) | 2024-09-16 | No | No | Historical |