Prescription drug · ANDA
Lisdexamfetamine Dimesylate (Lisdexamfetamine) NDC 0378-6855
Lisdexamfetamine dimesylate 20 mg/1 · Capsule · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-6855-77 | 0037868557700378685577 | 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-6855-77)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
- Active ingredients
- Lisdexamfetamine dimesylate — 20 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202835
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0378-6855_6e77cd71-95ae-4fa8-830b-ab62b714e4b9SPL ID 6e77cd71-95ae-4fa8-830b-ab62b714e4b9SPL set ID efbde0f6-b848-4664-b741-c6c630e66108RxCUI 854830, 854834, 854838, 854842, 854846, 854850, 1593856UNII SJT761GEGSUPC 0303786859771
- 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
N400378685577followed by a unit qualifier and the quantityPackage 00378-6855-77. 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 c…
Excerpt only. Read the full label for complete information.
About NDC 0378-6855
- What is NDC 0378-6855?
- 0378-6855 is the product NDC for Lisdexamfetamine Dimesylate (lisdexamfetamine), Lisdexamfetamine dimesylate 20 mg/1 capsule, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lisdexamfetamine Dimesylate (Lisdexamfetamine).
- What is the active ingredient?
- Lisdexamfetamine dimesylate.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 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 20 mg/1 | CapsuleOral | American Health Packaging | 60687-896 | 60687-0896-21 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 70 mg/1 | CapsuleOral | Sandoz Inc | 0781-2481 | 00781-2481-01 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 40 mg/1 | CapsuleOral | Sandoz Inc | 0781-2478 | 00781-2478-01 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 50 mg/1 | CapsuleOral | Sandoz Inc | 0781-2479 | 00781-2479-01 |
| Lisdexamfetamine dimesylate | Lisdexamfetamine dimesylate 60 mg/1 | CapsuleOral | Sandoz Inc | 0781-2480 | 00781-2480-01 |
Other NDCs under ANDA 202835
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 | Lisdexamfetamine dimesylate 10 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-6854 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 30 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-6856 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 40 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-6857 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 50 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-6858 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 60 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-6859 |
| Lisdexamfetamine Dimesylatelisdexamfetamine | Lisdexamfetamine dimesylate 70 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-6860 |