Prescription drug · ANDA
Methylphenidate Hydrochloride NDC 13811-707
Methylphenidate hydrochloride 27 mg/1 · Tablet, Extended release · Oral · Trigen Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13811-707-10 | 13811070710 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-707-10)Marketed from Aug 14, 2017 |
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 — 27 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Trigen Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205327
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 13811-707_0944cf70-d59a-483b-9698-e96ef955a65aSPL ID 0944cf70-d59a-483b-9698-e96ef955a65aSPL set ID c45dc1de-adfa-4b3c-a7dc-cffbc8eac74fRxCUI 1091155, 1091170, 1091185, 1091210, 1995461UNII 4B3SC438HIUPC 0313811706109, 0313811708103
- 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
N413811070710followed by a unit qualifier and the quantityPackage 13811-0707-10. 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 hyperactivit…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205327
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 18 mg/1 | Tablet, Extended releaseOral | Trigen Laboratories, LLC | 13811-706 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 72 mg/1 | Tablet, Extended releaseOral | Trigen Laboratories, LLC | 13811-710 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 36 mg/1 | Tablet, Extended releaseOral | Trigen Laboratories, LLC | 13811-708 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 54 mg/1 | Tablet, Extended releaseOral | Trigen Laboratories, LLC | 13811-709 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 27 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-925 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 18 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-924 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 36 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-926 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 54 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-927 |