Prescription drug · ANDA
Lisdexamfetamine Dimesylate NDC 42858-161
Lisdexamfetamine dimesylate 10 mg/1 · Capsule · Oral · Rhodes Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42858-161-01 | 42858016101 | 100 CAPSULE in 1 BOTTLE, PLASTIC (42858-161-01)Marketed from Jan 30, 2024 |
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 dimesylate
- Active ingredients
- Lisdexamfetamine dimesylate — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Rhodes Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215330
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 42858-161_0002e227-1109-4ecc-a8c5-4b4f11fac3ccSPL ID 0002e227-1109-4ecc-a8c5-4b4f11fac3ccSPL set ID d918b40d-a461-41bc-b6c0-83dc76c28e32RxCUI 854830, 854834, 854838, 854842, 854846, 854850, 1593856UNII SJT761GEGSUPC 0342858167017, 0342858162012, 0342858165013, 0342858166010, 0342858163019, 0342858164016
- 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
N442858016101followed by a unit qualifier and the quantityPackage 42858-0161-01. 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) ] . Lisdexamfetamine dimesylate capsules are a central nervous system (CNS) stimulant indicated for the treatment of ( 1 ): Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older Moderate to severe binge eating disorder (BED) in adults Limitations of Use: The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215330
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 Dimesylate | Lisdexamfetamine dimesylate 10 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2451 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2455 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 20 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2452 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2454 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 70 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2458 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2456 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 60 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2457 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 20 mg/1 | CapsuleOral | Rhodes Pharmaceuticals LLC | 42858-162 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 50 mg/1 | CapsuleOral | Rhodes Pharmaceuticals LLC | 42858-165 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 30 mg/1 | CapsuleOral | Rhodes Pharmaceuticals LLC | 42858-163 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 40 mg/1 | CapsuleOral | Rhodes Pharmaceuticals LLC | 42858-164 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 60 mg/1 | CapsuleOral | Rhodes Pharmaceuticals LLC | 42858-166 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 70 mg/1 | CapsuleOral | Rhodes Pharmaceuticals LLC | 42858-167 |