Prescription drug · NDA
Ritalin LA (Methylphenidate hydrochloride) NDC 0078-0424
Methylphenidate hydrochloride 10 mg/1 · Capsule, Extended release · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Ritalin LASuffix: LA
- Generic name (nonproprietary)
- methylphenidate hydrochloride
- Active ingredients
- Methylphenidate hydrochloride — 10 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021284
- Marketing start
- Marketing end
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0078-0424_8f4647d0-4965-4dee-8f60-1340ef9be3deSPL ID 8f4647d0-4965-4dee-8f60-1340ef9be3deSPL set ID effd952d-ac94-47bb-b107-589a4934dccaRxCUI 1091143, 1091167, 1091182, 1091197, 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.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Ritalin LA ® is 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 Ritalin LA 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 )]. Ritalin LA is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age ( 1 ). Lim…
Excerpt only. Read the full label for complete information.
About NDC 0078-0424
- What is NDC 0078-0424?
- 0078-0424 is the product NDC for Ritalin LA (methylphenidate hydrochloride), Methylphenidate hydrochloride 10 mg/1 capsule, extended release, listed with the FDA by Novartis Pharmaceuticals Corporation.
- What drug is associated with this NDC?
- Ritalin LA (Methylphenidate hydrochloride).
- What is the active ingredient?
- Methylphenidate hydrochloride.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ritalin LA?
- 3 other product NDCs are listed under this name. See all Ritalin LA NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ritalin LA products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ritalin LAmethylphenidate hydrochloride | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0370 | 00078-0370-05 |
| 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 | 00078-0372-05 |
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 10 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2361 |
| 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 |