Prescription drug · ANDA
Lisdexamfetamine dimesylate (Lisdexamfetamine dimesylate capsules) NDC 43547-608
Lisdexamfetamine dimesylate 70 mg/1 · Capsule · Oral · Solco Healthcare US,LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-608-10 | 4354706081043547060810 | 100 CAPSULE in 1 BOTTLE (43547-608-10)Marketed from Aug 26, 2023 |
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 capsules
- Active ingredients
- Lisdexamfetamine dimesylate — 70 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Solco Healthcare US,LLCNDC labeler code 43547
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216266
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 43547-608_d6435613-e052-4b4f-8bf7-4acb7458d8dfSPL ID d6435613-e052-4b4f-8bf7-4acb7458d8dfSPL set ID 68b10d9f-ca3e-493d-a309-45f1d7e08061RxCUI 854830, 854834, 854838, 854842, 854846, 854850, 1593856UNII SJT761GEGSUPC 0343547604103, 0343547605100, 0343547607104, 0343547603106
- 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
N443547060810followed by a unit qualifier and the quantityPackage 43547-0608-10. 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 dimesylat…
Excerpt only. Read the full label for complete information.
About NDC 43547-608
- What is NDC 43547-608?
- 43547-608 is the product NDC for Lisdexamfetamine dimesylate (lisdexamfetamine dimesylate capsules), Lisdexamfetamine dimesylate 70 mg/1 capsule, listed with the FDA by Solco Healthcare US,LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lisdexamfetamine dimesylate (Lisdexamfetamine dimesylate capsules).
- What is the active ingredient?
- Lisdexamfetamine dimesylate.
- Who is the labeler?
- Solco Healthcare US,LLC, NDC labeler code 43547. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lisdexamfetamine dimesylate?
- 159 other product NDCs are listed under this name. See all Lisdexamfetamine dimesylate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lisdexamfetamine dimesylate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 20 mg/1 | CapsuleOral | American Health Packaging | 60687-896 | 60687-0896-21 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 30 mg/1 | CapsuleOral | American Health Packaging | 60687-907 | 60687-0907-21 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 40 mg/1 | CapsuleOral | American Health Packaging | 60687-918 | 60687-0918-21 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 50 mg/1 | CapsuleOral | American Health Packaging | 60687-929 | 60687-0929-21 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 60 mg/1 | CapsuleOral | American Health Packaging | 60687-940 | 60687-0940-21 |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate 70 mg/1 | CapsuleOral | American Health Packaging | 60687-951 | 60687-0951-21 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 10 mg/1 | CapsuleOral | Sandoz Inc | 0781-2299 | 00781-2299-01 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 20 mg/1 | CapsuleOral | Sandoz Inc | 0781-2476 | 00781-2476-01 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 30 mg/1 | CapsuleOral | Sandoz Inc | 0781-2477 | 00781-2477-01 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 40 mg/1 | CapsuleOral | Sandoz Inc | 0781-2478 | 00781-2478-01 |
Other NDCs under ANDA 216266
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 dimesylatelisdexamfetamine dimesylate capsules | Lisdexamfetamine dimesylate 10 mg/1 | CapsuleOral | Solco Healthcare US,LLC | 43547-602 |
| Lisdexamfetamine dimesylatelisdexamfetamine dimesylate capsules | Lisdexamfetamine dimesylate 20 mg/1 | CapsuleOral | Solco Healthcare US,LLC | 43547-603 |
| Lisdexamfetamine dimesylatelisdexamfetamine dimesylate capsules | Lisdexamfetamine dimesylate 30 mg/1 | CapsuleOral | Solco Healthcare US,LLC | 43547-604 |
| Lisdexamfetamine dimesylatelisdexamfetamine dimesylate capsules | Lisdexamfetamine dimesylate 40 mg/1 | CapsuleOral | Solco Healthcare US,LLC | 43547-605 |
| Lisdexamfetamine dimesylatelisdexamfetamine dimesylate capsules | Lisdexamfetamine dimesylate 50 mg/1 | CapsuleOral | Solco Healthcare US,LLC | 43547-606 |
| Lisdexamfetamine dimesylatelisdexamfetamine dimesylate capsules | Lisdexamfetamine dimesylate 60 mg/1 | CapsuleOral | Solco Healthcare US,LLC | 43547-607 |