Prescription drug · NDA AUTHORIZED GENERIC
Methylphenidate NDC 0781-2361
Methylphenidate hydrochloride 10 mg/1 · Capsule, Extended release · Oral · Sandoz Inc
NDC codes
FDA NDC DirectoryProduct 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 IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021284
- Marketing start
- Marketing end
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0781-2361_2a42277a-d670-4bae-b49d-fd1d8e13afffSPL ID 2a42277a-d670-4bae-b49d-fd1d8e13afffSPL set ID 1f8983ce-71b8-4c62-830d-e4692ddededaRxCUI 1806177, 1806179, 1806183, 1806195UNII 4B3SC438HIUPC 0307812364017, 0307812362013
- 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.
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.
About NDC 0781-2361
- What is NDC 0781-2361?
- 0781-2361 is the product NDC for Methylphenidate, Methylphenidate hydrochloride 10 mg/1 capsule, extended release, listed with the FDA by Sandoz Inc.
- What drug is associated with this NDC?
- Methylphenidate.
- What is the active ingredient?
- Methylphenidate hydrochloride.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Methylphenidate?
- 13 other product NDCs are listed under this name. See all Methylphenidate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Methylphenidate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Methylphenidate | Methylphenidate 1.1 mg/h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-8260 | 00378-8260-93 |
| Methylphenidate | Methylphenidate 1.6 mg/h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-8261 | 00378-8261-93 |
| Methylphenidate | Methylphenidate 2.2 mg/h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-8262 | 00378-8262-93 |
| Methylphenidate | Methylphenidate 3.3 mg/h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-8263 | 00378-8263-93 |
| Methylphenidatemethylphenidate hydrochloride | Methylphenidate hydrochloride 5 mg/5mL | SolutionOral | KVK-Tech, Inc. | 10702-163 | 10702-0163-50 |
| Methylphenidatemethylphenidate hydrochloride | Methylphenidate hydrochloride 10 mg/5mL | SolutionOral | KVK-Tech, Inc. | 10702-164 | 10702-0164-50 |
| Methylphenidate | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2362 | 00781-2362-01 |
| Methylphenidate | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2363 | 00781-2363-01 |
| Methylphenidate | Methylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2364 | 00781-2364-01 |
| Methylphenidate | Methylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2383 | 00781-2383-01 |
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 |
|---|---|---|---|---|
| Methylphenidate | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2362 |
| 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 10 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2383 |
| 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 20 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0370 |
| Ritalin LAmethylphenidate hydrochloride | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0371 |
| 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 |