Prescription drug · NDA AUTHORIZED GENERIC

Methylphenidate Hydrochloride NDC 13811-711

Methylphenidate hydrochloride 45 mg/1 · Tablet, Extended release · Oral · Trigen Laboratories, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)13811-711Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13811-0711Add 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 NDC11-digit (billing)PackageCopy
13811-711-301381107113030 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-711-30)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 — 45 mg/1
Dosage form
Tablet, Extended release
Route
Oral
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 13811-711_ba649db4-df0d-4587-8370-3f866e66e54bSPL ID ba649db4-df0d-4587-8370-3f866e66e54bSPL set ID dd8d7b6e-c23d-4e16-bb53-959e9127ebc6RxCUI 2605796, 2605798UNII 4B3SC438HIUPC 0313811700305, 0313811711301

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

N413811071130 followed by a unit qualifier and the quantity

Package 13811-0711-30. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 216117

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

FDA NDC Directory listings under NDA 216117
ProductStrengthForm · routeLabelerProduct NDC
Methylphenidate HydrochlorideMethylphenidate hydrochloride 63 mg/1Tablet, Extended releaseOralTrigen Laboratories, LLC13811-700
Relexxiimethylphenidate hydrochlorideMethylphenidate hydrochloride 63 mg/1Tablet, Extended releaseOralVertical Pharmaceuticals, LLC68025-089
Relexxiimethylphenidate hydrochlorideMethylphenidate hydrochloride 72 mg/1Tablet, Extended releaseOralVertical Pharmaceuticals, LLC68025-084
Relexxiimethylphenidate hydrochlorideMethylphenidate hydrochloride 45 mg/1Tablet, Extended releaseOralVertical Pharmaceuticals, LLC68025-088
Relexxiimethylphenidate hydrochlorideMethylphenidate hydrochloride 54 mg/1Tablet, Extended releaseOralVertical Pharmaceuticals, LLC68025-098
Relexxiimethylphenidate hydrochlorideMethylphenidate hydrochloride 18 mg/1Tablet, Extended releaseOralVertical Pharmaceuticals, LLC68025-095
Relexxiimethylphenidate hydrochlorideMethylphenidate hydrochloride 27 mg/1Tablet, Extended releaseOralVertical Pharmaceuticals, LLC68025-096
Relexxiimethylphenidate hydrochlorideMethylphenidate hydrochloride 36 mg/1Tablet, Extended releaseOralVertical Pharmaceuticals, LLC68025-097

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Methylphenidate Hydrochloride NDC 13811-711 | Med-Code