Prescription drug · ANDA
Lisdexamfetamine Dimesylate NDC 0527-4665
Lisdexamfetamine dimesylate 50 mg/1 · Capsule · Oral · Lannett Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-4665-37 | 00527466537 | 100 CAPSULE in 1 BOTTLE (0527-4665-37)Marketed from Aug 25, 2023 |
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
- Capsule
- Route
- Oral
- Labeler
- Lannett Company, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215802
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0527-4665_164b5658-3c14-44f5-b10a-839909184984SPL ID 164b5658-3c14-44f5-b10a-839909184984
- 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
N400527466537followed by a unit qualifier and the quantityPackage 00527-4665-37. 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.
Other NDCs under ANDA 215802
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 60 mg/1 | CapsuleOral | Lannett Company, LLC | 0527-4666 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 70 mg/1 | CapsuleOral | Lannett Company, LLC | 0527-4667 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 10 mg/1 | CapsuleOral | Lannett Company, LLC | 0527-4661 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 20 mg/1 | CapsuleOral | Lannett Company, LLC | 0527-4662 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 30 mg/1 | CapsuleOral | Lannett Company, LLC | 0527-4663 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 40 mg/1 | CapsuleOral | Lannett Company, LLC | 0527-4664 |