Dexmethylphenidate Hydrochloride NDC 43386-861

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-861Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0861Add 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
43386-861-01	43386086101	100 TABLET in 1 BOTTLE (43386-861-01)Marketed from Dec 4, 2015

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): Dexmethylphenidate Hydrochloride
Generic name (nonproprietary): dexmethylphenidate hydrochloride
Active ingredients: Dexmethylphenidate hydrochloride — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Lupin Pharmaceuticals,Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204534
Marketing start: Dec 4, 2015
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 43386-861_4d2d72fd-412e-4556-9adc-d4673576a29cSPL ID 4d2d72fd-412e-4556-9adc-d4673576a29cSPL set ID a61932ef-c2b6-4363-a21d-1f0358f317b6RxCUI 899518, 899548, 899557UNII 1678OK0E08
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

N443386086101 followed by a unit qualifier and the quantity

Package 43386-0861-01. 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 Jan 30, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Dexmethylphenidate hydrochloride tablet is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )]. Dexmethylphenidate hydrochloride is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204534

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

FDA NDC Directory listings under ANDA 204534
Product	Strength	Form · route	Labeler	Product NDC
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 2.5 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-862
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 5 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-860