Prescription drug · ANDA
Methylphenidate Hydrochloride NDC 0115-1736
Methylphenidate hydrochloride 10 mg/1 · Capsule, Extended release · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0115-1736-01 | 00115173601 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1736-01)Marketed from Sep 20, 2016 |
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 — 10 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205105
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0115-1736_b0804310-a328-4743-b417-67c66f56fc94SPL ID b0804310-a328-4743-b417-67c66f56fc94SPL set ID 10aa0dc0-bd0e-4927-a19a-8722d78ad67dRxCUI 1806181, 1806187, 1806189, 1806191, 1806193, 1806197UNII 4B3SC438HIUPC 0301151741010, 0301157739011
- 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
N400115173601followed by a unit qualifier and the quantityPackage 00115-1736-01. 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 15 years of age. 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) stimulant indicated for the treatment of …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205105
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 20 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1737 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1738 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1739 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 50 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1740 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1741 |