Lisdexamfetamine dimesylate
- Product NDC
- 72205-133
- 11-digit product format
- 722050133
- Labeler code
- 72205
- Product ID
- 72205-133_a79cb70c-0bfa-4d68-9a21-a5ef4bc3c811
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lisdexamfetamine dimesylate
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA218306
- Marketing category
- ANDA
- Marketing start
- 2024-02-02
- Substance
- LISDEXAMFETAMINE DIMESYLATE
- Active strength
- 20 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
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LISDEXAMFETAMINE DIMESYLATE | 20 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 |
|---|
| 72205-133-91 | 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 |
|---|
| 72205-133 | LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE [NOVADOZ PHARMACEUTICALS LLC] | 1 | Current NDC, 1 package rows | 20240220_a79cb70c-0bfa-4d68-9a21-a5ef4bc3c811.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72205-133-91 | 72205013391 | 100 TABLET, CHEWABLE in 1 BOTTLE (72205-133-91) | 2024-02-17 | No | No | Historical |