Prescription drug · NDA AUTHORIZED GENERIC
Methylphenidate NDC 0781-2383
Methylphenidate hydrochloride 10 mg/1 · Capsule, Extended release · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-2383-01 | 00781238301 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2383-01)Marketed from Mar 3, 2025 |
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)
- Methylphenidate
- Generic name (nonproprietary)
- methylphenidate
- Active ingredients
- Methylphenidate hydrochloride — 10 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021284
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0781-2383_ade65b90-a3e4-4df4-a066-b72f161dc306SPL ID ade65b90-a3e4-4df4-a066-b72f161dc306SPL set ID 44386394-d2a3-4483-abe1-6c5c634cc501RxCUI 1806177, 1806179, 1806183, 1806195UNII 4B3SC438HI
- 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
N400781238301followed by a unit qualifier and the quantityPackage 00781-2383-01. 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 hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies ( 14 )] . Limitations of Use The use of methylphenidate hydrochloride extended-release 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 ( 5.7 ), Use in Specific Populations ( 8.4 )]. Methylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimula…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021284
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 |
|---|---|---|---|---|
| Ritalin LAmethylphenidate hydrochloride | Methylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0372 |
| Ritalin LAmethylphenidate hydrochloride | Methylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0424 |
| Methylphenidate | Methylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2361 |
| Methylphenidate | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2362 |
| Ritalin LAmethylphenidate hydrochloride | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0370 |
| Methylphenidate | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2363 |
| Methylphenidate | Methylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2364 |
| Methylphenidate | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2384 |
| Methylphenidate | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2385 |
| Methylphenidate | Methylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2386 |
| Ritalin LAmethylphenidate hydrochloride | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0371 |