Prescription drug · NDA
Relexxii (methylphenidate hydrochloride) NDC 68025-098
Methylphenidate hydrochloride 54 mg/1 · Tablet, Extended release · Oral · Vertical Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68025-098-10 | 68025009810 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-098-10)Marketed from Nov 1, 2023 | |
| 68025-098-30 | 68025009830 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-098-30)Marketed from Aug 12, 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)
- Relexxii
- Generic name (nonproprietary)
- methylphenidate hydrochloride
- Active ingredients
- Methylphenidate hydrochloride — 54 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216117
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 68025-098_86f477e9-07fc-466b-913e-1a4434c91df4SPL ID 86f477e9-07fc-466b-913e-1a4434c91df4SPL set ID 22d5fa47-b5b9-4fd9-980c-4eb88e95ae5dRxCUI 1091155, 1091170, 1091185, 1091210, 1995461, 2052826, 2605796, 2605798, 2605943, 2605946, 2668496, 2668499, 2668502, 2668505UNII 4B3SC438HIUPC 0368025097109, 0368025096300, 0368025096102, 0368025084307, 0368025095303, 0368025098304, 0368025095105, 0368025098106, 0368025089302, 0368025088305, 0368025097307
- 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
N468025009810followed by a unit qualifier and the quantityPackage 68025-0098-10. 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)
RELEXXII is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [ see Clinical Studies ( 14 )] . Limitations of Use The use of RELEXXII 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 ( 5.7 ), Use in Specific Populations ( 8.4 )] . RELEXXII ® is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up t…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 216117
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 |
|---|---|---|---|---|
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 63 mg/1 | Tablet, Extended releaseOral | Trigen Laboratories, LLC | 13811-700 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 45 mg/1 | Tablet, Extended releaseOral | Trigen Laboratories, LLC | 13811-711 |
| Relexxiimethylphenidate hydrochloride | Methylphenidate hydrochloride 63 mg/1 | Tablet, Extended releaseOral | Vertical Pharmaceuticals, LLC | 68025-089 |
| Relexxiimethylphenidate hydrochloride | Methylphenidate hydrochloride 72 mg/1 | Tablet, Extended releaseOral | Vertical Pharmaceuticals, LLC | 68025-084 |
| Relexxiimethylphenidate hydrochloride | Methylphenidate hydrochloride 45 mg/1 | Tablet, Extended releaseOral | Vertical Pharmaceuticals, LLC | 68025-088 |
| Relexxiimethylphenidate hydrochloride | Methylphenidate hydrochloride 18 mg/1 | Tablet, Extended releaseOral | Vertical Pharmaceuticals, LLC | 68025-095 |
| Relexxiimethylphenidate hydrochloride | Methylphenidate hydrochloride 27 mg/1 | Tablet, Extended releaseOral | Vertical Pharmaceuticals, LLC | 68025-096 |
| Relexxiimethylphenidate hydrochloride | Methylphenidate hydrochloride 36 mg/1 | Tablet, Extended releaseOral | Vertical Pharmaceuticals, LLC | 68025-097 |