Prescription drug · ANDA
Methylphenidate Hydrochloride NDC 0527-3312
Methylphenidate hydrochloride 36 mg/1 · Tablet, Extended release · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-3312-37 | 00527331237 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-3312-37)Marketed from Apr 24, 2019 |
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 Hydrochloride
- Generic name (nonproprietary)
- methylphenidate hydrochloride
- Active ingredients
- Methylphenidate hydrochloride — 36 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Lannett Company, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211918
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0527-3312_2b8fd6f1-882d-4344-8617-0b2f66dfbaafSPL ID 2b8fd6f1-882d-4344-8617-0b2f66dfbaafSPL set ID 44737c1d-fe75-409e-8a58-591696d3d7aaRxCUI 1091155, 1091170, 1091185, 1091210UNII 4B3SC438HIUPC 0305273310376
- 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
N400527331237followed by a unit qualifier and the quantityPackage 00527-3312-37. 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 tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use The use of methylphenidate hydrochloride extended-release 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 (5.7) and Use in Specific Populations (8.4) ] . Methylphenidate hydrochloride extended-release tablets are a CNS stimulant indicated for the treatment of attention deficit hyperactivity d…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211918
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 Hydrochloride | Methylphenidate hydrochloride 54 mg/1 | Tablet, Extended releaseOral | Lannett Company, Inc. | 0527-3313 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 18 mg/1 | Tablet, Extended releaseOral | Lannett Company, Inc. | 0527-3310 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 27 mg/1 | Tablet, Extended releaseOral | Lannett Company, Inc. | 0527-3311 |