Prescription drug · NDA
Vyvanse (lisdexamfetamine dimesylate) NDC 59417-118
Lisdexamfetamine dimesylate 40 mg/1 · Tablet, Chewable · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59417-118-01 | 59417011801 | 100 TABLET, CHEWABLE in 1 BOTTLE (59417-118-01)Marketed from Jan 28, 2017 |
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)
- Vyvanse
- Generic name (nonproprietary)
- lisdexamfetamine dimesylate
- Active ingredients
- Lisdexamfetamine dimesylate — 40 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208510
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 59417-118_81d087b6-4cb4-466a-9693-679edeb062e2SPL ID 81d087b6-4cb4-466a-9693-679edeb062e2SPL set ID 704e4378-ca83-445c-8b45-3cfa51c1ecadRxCUI 854830, 854832, 854834, 854836, 854838, 854840, 854842, 854844, 854846, 854848, 854850, 854852, 1593856, 1593858, 1871456, 1871459, 1871460, 1871461, 1871462, 1871463, 1871464, 1871465, 1871466, 1871467, 1871468, 1871469UNII 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
N459417011801followed by a unit qualifier and the quantityPackage 59417-0118-01. 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)
VYVANSE ® is 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) ] . VYVANSE is 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 VYVANSE is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse react…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 208510
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 |
|---|---|---|---|---|
| Vyvanselisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 20 mg/1 | Tablet, ChewableOral | Takeda Pharmaceuticals America, Inc. | 59417-116 |
| Vyvanselisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 10 mg/1 | Tablet, ChewableOral | Takeda Pharmaceuticals America, Inc. | 59417-115 |
| Vyvanselisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 60 mg/1 | Tablet, ChewableOral | Takeda Pharmaceuticals America, Inc. | 59417-120 |
| Vyvanselisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 30 mg/1 | Tablet, ChewableOral | Takeda Pharmaceuticals America, Inc. | 59417-117 |
| Vyvanselisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 50 mg/1 | Tablet, ChewableOral | Takeda Pharmaceuticals America, Inc. | 59417-119 |