Prescription drug · ANDA
Lisdexamfetamine dimesylate NDC 72205-136
Lisdexamfetamine dimesylate 50 mg/1 · Tablet, Chewable · Oral · Novadoz Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72205-136-91 | 72205013691 | 100 TABLET, CHEWABLE in 1 BOTTLE (72205-136-91)Marketed from Feb 17, 2024 |
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)
- Lisdexamfetamine dimesylate
- Generic name (nonproprietary)
- lisdexamfetamine dimesylate
- Active ingredients
- Lisdexamfetamine dimesylate — 50 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Novadoz Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218306
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 72205-136_a79cb70c-0bfa-4d68-9a21-a5ef4bc3c811SPL ID a79cb70c-0bfa-4d68-9a21-a5ef4bc3c811SPL set ID a79cb70c-0bfa-4d68-9a21-a5ef4bc3c811RxCUI 1871456, 1871460, 1871462, 1871464, 1871466, 1871468UNII SJT761GEGSUPC 0372205133914, 0372205137912, 0372205135918, 0372205134911, 0372205136915, 0372205132917
- 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
N472205013691followed by a unit qualifier and the quantityPackage 72205-0136-91. 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 : Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older [ see Use in Specific Populations (8.4) ] . Lisdexamfetamine dimesylate chewable tablets are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse eve…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218306
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 | Novadoz Pharmaceuticals LLC | 72205-132 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 20 mg/1 | Tablet, ChewableOral | Novadoz Pharmaceuticals LLC | 72205-133 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 30 mg/1 | Tablet, ChewableOral | Novadoz Pharmaceuticals LLC | 72205-134 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 40 mg/1 | Tablet, ChewableOral | Novadoz Pharmaceuticals LLC | 72205-135 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 60 mg/1 | Tablet, ChewableOral | Novadoz Pharmaceuticals LLC | 72205-137 |