Prescription drug · NDA
Ritalin LA (methylphenidate hydrochloride) NDC 0078-0370
Methylphenidate hydrochloride 20 mg/1 · Capsule, Extended release · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0370-05 | 00078037005 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0370-05)Marketed from Jun 5, 2002 |
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)
- Ritalin LASuffix: LA
- Generic name (nonproprietary)
- methylphenidate hydrochloride
- Active ingredients
- Methylphenidate hydrochloride — 20 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- 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 0078-0370_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.
- NDC on a medical claim
N400078037005followed by a unit qualifier and the quantityPackage 00078-0370-05. 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)
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.
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 |
| 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 30 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0371 |