Prescription drug · ANDA
Lisdexamfetamine Dimesylate (Lisdexamfetamine) NDC 65162-024
Lisdexamfetamine dimesylate 30 mg/1 · Capsule · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-024-09 | 6516200240965162002409 | 90 CAPSULE in 1 BOTTLE (65162-024-09)Marketed from Aug 28, 2023 |
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 — 30 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- 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 65162-024_4cc5e658-25c6-4a58-a93a-6e35242d6de4SPL ID 4cc5e658-25c6-4a58-a93a-6e35242d6de4SPL set ID c11cb3b6-3dff-477b-a249-b4c3118edc5fRxCUI 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
N465162002409followed by a unit qualifier and the quantityPackage 65162-0024-09. 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: The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5) , Use in Specific Populations (8.4) ] . Lisdexamfetamine dimesylate capsules a…
Excerpt only. Read the full label for complete information.
About NDC 65162-024
- What is NDC 65162-024?
- 65162-024 is the product NDC for Lisdexamfetamine Dimesylate (lisdexamfetamine), Lisdexamfetamine dimesylate 30 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lisdexamfetamine Dimesylate (Lisdexamfetamine).
- What is the active ingredient?
- Lisdexamfetamine dimesylate.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lisdexamfetamine Dimesylate?
- 159 other product NDCs are listed under this name. See all Lisdexamfetamine Dimesylate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lisdexamfetamine Dimesylate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 30 mg/1 | CapsuleOral | American Health Packaging | 60687-907 | 60687-0907-21 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 40 mg/1 | CapsuleOral | American Health Packaging | 60687-918 | 60687-0918-21 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 70 mg/1 | CapsuleOral | American Health Packaging | 60687-951 | 60687-0951-21 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 20 mg/1 | CapsuleOral | American Health Packaging | 60687-896 | 60687-0896-21 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 50 mg/1 | CapsuleOral | American Health Packaging | 60687-929 | 60687-0929-21 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 60 mg/1 | CapsuleOral | American Health Packaging | 60687-940 | 60687-0940-21 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 40 mg/1 | CapsuleOral | Sandoz Inc | 0781-2478 | 00781-2478-01 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 50 mg/1 | CapsuleOral | Sandoz Inc | 0781-2479 | 00781-2479-01 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 60 mg/1 | CapsuleOral | Sandoz Inc | 0781-2480 | 00781-2480-01 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 70 mg/1 | CapsuleOral | Sandoz Inc | 0781-2481 | 00781-2481-01 |
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 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 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 50 mg/1 | CapsuleOral | AvKARE | 42291-039 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 20 mg/1 | CapsuleOral | AvKARE | 42291-036 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 30 mg/1 | CapsuleOral | AvKARE | 42291-037 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 40 mg/1 | CapsuleOral | AvKARE | 42291-038 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 60 mg/1 | CapsuleOral | AvKARE | 42291-040 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 70 mg/1 | CapsuleOral | AvKARE | 42291-041 |