Prescription drug · NDA AUTHORIZED GENERIC
Methylphenidate Hydrochloride NDC 13811-700
Methylphenidate hydrochloride 63 mg/1 · Tablet, Extended release · Oral · Trigen Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13811-700-30 | 13811070030 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-700-30)Marketed from Jun 23, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 63 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Trigen Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 216117
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 13811-700_ba649db4-df0d-4587-8370-3f866e66e54bSPL ID ba649db4-df0d-4587-8370-3f866e66e54bSPL set ID dd8d7b6e-c23d-4e16-bb53-959e9127ebc6RxCUI 2605796, 2605798UNII 4B3SC438HIUPC 0313811700305, 0313811711301
- 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
N413811070030followed by a unit qualifier and the quantityPackage 13811-0700-30. 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 adults (up to the age of 65 years) and pediatric patients 6 years of age and older [ see Clinical Studies ( 14 )] . 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 ), Use in Specific Populations ( 8.4 )]. Methylphenidate hydrochloride extended-release tablets ar…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 216117
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 45 mg/1 | Tablet, Extended releaseOral | Trigen Laboratories, LLC | 13811-711 |
| Relexxiimethylphenidate hydrochloride | Methylphenidate hydrochloride 63 mg/1 | Tablet, Extended releaseOral | Vertical Pharmaceuticals, LLC | 68025-089 |
| Relexxiimethylphenidate hydrochloride | Methylphenidate hydrochloride 72 mg/1 | Tablet, Extended releaseOral | Vertical Pharmaceuticals, LLC | 68025-084 |
| Relexxiimethylphenidate hydrochloride | Methylphenidate hydrochloride 45 mg/1 | Tablet, Extended releaseOral | Vertical Pharmaceuticals, LLC | 68025-088 |
| Relexxiimethylphenidate hydrochloride | Methylphenidate hydrochloride 54 mg/1 | Tablet, Extended releaseOral | Vertical Pharmaceuticals, LLC | 68025-098 |
| Relexxiimethylphenidate hydrochloride | Methylphenidate hydrochloride 18 mg/1 | Tablet, Extended releaseOral | Vertical Pharmaceuticals, LLC | 68025-095 |
| Relexxiimethylphenidate hydrochloride | Methylphenidate hydrochloride 27 mg/1 | Tablet, Extended releaseOral | Vertical Pharmaceuticals, LLC | 68025-096 |
| Relexxiimethylphenidate hydrochloride | Methylphenidate hydrochloride 36 mg/1 | Tablet, Extended releaseOral | Vertical Pharmaceuticals, LLC | 68025-097 |