Prescription drug · ANDA
Lisdexamfetamine Dimesylate NDC 0406-5129
Lisdexamfetamine dimesylate 60 mg/1 · Tablet, Chewable · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-5129-01 | 00406512901 | 100 TABLET, CHEWABLE in 1 BOTTLE (0406-5129-01)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 — 60 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- SpecGx LLC
- 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 0406-5129_02215a03-fa4d-4785-9d38-4f22d92faf31SPL ID 02215a03-fa4d-4785-9d38-4f22d92faf31SPL set ID 3a79b2ab-4131-4978-99a0-0119df57d5feRxCUI 1871456, 1871460, 1871462, 1871464, 1871466, 1871468UNII SJT761GEGSUPC 0304065125013, 0304065128014, 0304065126010, 0304065127017, 0304065129011, 0304065124016
- 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
N400406512901followed by a unit qualifier and the quantityPackage 00406-5129-01. 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 chewable tablets 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 chewable tablets 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 dim…
Excerpt only. Read the full label for complete information.
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 50 mg/1 | Tablet, ChewableOral | SpecGx LLC | 0406-5128 |