Prescription drug · ANDA
Lisdexamfetamine Dimesylate (lisdexamfetamine) NDC 42291-036
Lisdexamfetamine dimesylate 20 mg/1 · Capsule · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-036-90 | 42291003690 | 90 CAPSULE in 1 BOTTLE (42291-036-90)Marketed from Jun 4, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Lisdexamfetamine Dimesylate
- Generic name (nonproprietary)
- lisdexamfetamine
- Active ingredients
- Lisdexamfetamine dimesylate — 20 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202830
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 42291-036_36c401bd-e228-6fbd-e063-6394a90a5f1fSPL ID 36c401bd-e228-6fbd-e063-6394a90a5f1fSPL set ID 36c40404-fe94-6fb7-e063-6394a90a2657RxCUI 854830, 854834, 854838, 854842, 854846, 854850UNII SJT761GEGS
- Pharmacologic class
- Central Nervous System Stimulant
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N442291003690followed by a unit qualifier and the quantityPackage 42291-0036-90. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Lisdexamfetamine dimesylate capsules are indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1) ] Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2) ] . Limitations of Use: Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older [see Use in Specific Populations (8.4) ] . Lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202830
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 30 mg/1 | CapsuleOral | AvKARE | 42291-037 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 70 mg/1 | CapsuleOral | AvKARE | 42291-041 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 40 mg/1 | CapsuleOral | AvKARE | 42291-038 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 50 mg/1 | CapsuleOral | AvKARE | 42291-039 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 60 mg/1 | CapsuleOral | AvKARE | 42291-040 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 30 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-024 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 20 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-023 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 70 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-028 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 40 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-025 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 50 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-026 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 60 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-027 |