Prescription drug · ANDA
Lisdexamfetamine dimesylate NDC 0480-3565
Lisdexamfetamine dimesylate 10 mg/1 · Capsule · Oral · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-3565-01 | 00480356501 | 100 CAPSULE in 1 BOTTLE (0480-3565-01)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 — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Teva Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202802
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0480-3565_7a1feaa2-6b58-4aff-a45b-533ee3174e53SPL ID 7a1feaa2-6b58-4aff-a45b-533ee3174e53SPL set ID c32b5dce-2de4-4db0-a4ba-d2ce3b0a32fcRxCUI 854830, 854834, 854838, 854842, 854846, 854850, 1593856UNII SJT761GEGSUPC 0304803567013, 0304803570013, 0304803569017, 0304803566016, 0304803565019
- 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
N400480356501followed by a unit qualifier and the quantityPackage 00480-3565-01. 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 )] . 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 caps…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202802
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 30 mg/1 | CapsuleOral | Teva Pharmaceuticals, Inc. | 0480-3567 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 70 mg/1 | CapsuleOral | Teva Pharmaceuticals, Inc. | 0480-3564 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 20 mg/1 | CapsuleOral | Teva Pharmaceuticals, Inc. | 0480-3566 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 40 mg/1 | CapsuleOral | Teva Pharmaceuticals, Inc. | 0480-3568 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 50 mg/1 | CapsuleOral | Teva Pharmaceuticals, Inc. | 0480-3569 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 60 mg/1 | CapsuleOral | Teva Pharmaceuticals, Inc. | 0480-3570 |