Prescription drug · NDA AUTHORIZED GENERIC
Methylphenidate Extended-Release NDC 62542-250
Methylphenidate 17.3 mg/1 · Tablet, Orally disintegrating · Oral · Neos Therapeutics, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62542-250-31 | 62542025031 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62542-250-31)Marketed from Jul 1, 2026 |
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)
- Methylphenidate Extended-Release
- Generic name (nonproprietary)
- methylphenidate extended-release
- Active ingredients
- Methylphenidate — 17.3 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Neos Therapeutics, LP
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 205489
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 62542-250_546188db-6a60-5a33-e063-6294a90ac39bSPL ID 546188db-6a60-5a33-e063-6294a90ac39bSPL set ID c2fec19b-6610-4ce0-8e60-f8218a11f62fRxCUI 1926840, 1926849, 1926853UNII 207ZZ9QZ49UPC 0362542100311, 0362542250313, 0362542350310
- 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
N462542025031followed by a unit qualifier and the quantityPackage 62542-0250-31. 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)
Methylphenidate extended-release orally disintegrating tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age [see Clinical Studies (14) ] . Limitations of Use The use of methylphenidate extended-release orally disintegrating tablets 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) ]. Methylphenidate extended-release orally disintegrating tablets is a central nervous syste…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 205489
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 Extended-Release | Methylphenidate 8.6 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics, LP | 62542-100 |
| Methylphenidate Extended-Release | Methylphenidate 25.9 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics, LP | 62542-350 |
| Cotempla XR-ODTmethylphenidate | Methylphenidate 8.6 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-100 |
| Cotempla XR-ODTmethylphenidate | Methylphenidate 17.3 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-200 |
| Cotempla XR-ODTmethylphenidate | Methylphenidate 25.9 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-300 |