Prescription drug · ANDA
Lisdexamfetamine Dimesylate NDC 0406-5128
Lisdexamfetamine dimesylate 50 mg/1 · Tablet, Chewable · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-5128-01 | 0040651280100406512801 | 100 TABLET, CHEWABLE in 1 BOTTLE (0406-5128-01)Marketed from Dec 17, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 50 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- SpecGx LLCNDC labeler code 0406
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218850
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0406-5128_b8fbbe5c-6972-454b-9738-4f4d8b2a7264SPL ID b8fbbe5c-6972-454b-9738-4f4d8b2a7264
- 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
N400406512801followed by a unit qualifier and the quantityPackage 00406-5128-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0406-5128
- What is NDC 0406-5128?
- 0406-5128 is the product NDC for Lisdexamfetamine Dimesylate, Lisdexamfetamine dimesylate 50 mg/1 tablet, chewable, listed with the FDA by SpecGx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lisdexamfetamine Dimesylate.
- What is the active ingredient?
- Lisdexamfetamine dimesylate.
- Who is the labeler?
- SpecGx LLC, NDC labeler code 0406. 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 218850
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 | Tablet, ChewableOral | SpecGx LLC | 0406-5124 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 20 mg/1 | Tablet, ChewableOral | SpecGx LLC | 0406-5125 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 30 mg/1 | Tablet, ChewableOral | SpecGx LLC | 0406-5126 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 40 mg/1 | Tablet, ChewableOral | SpecGx LLC | 0406-5127 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 60 mg/1 | Tablet, ChewableOral | SpecGx LLC | 0406-5129 |