Methylphenidate Hydrochloride NDC 13811-709

NDC codes

FDA NDC Directory

Product NDC (as listed)13811-709Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13811-0709Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
13811-709-10	13811070910	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-709-10)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 — 54 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: Aug 14, 2017
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 13811-709_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

N413811070910 followed by a unit qualifier and the quantity

Package 13811-0709-10. 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 Apr 24, 2026. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205327

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 205327
Product	Strength	Form · route	Labeler	Product NDC
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 27 mg/1	Tablet, Extended releaseOral	Trigen Laboratories, LLC	13811-707
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 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