Focalin XR (Dexmethylphenidate hydrochloride) NDC 0078-0432

Product information

Brand name (proprietary)

Focalin XRSuffix: XR

Generic name (nonproprietary)

dexmethylphenidate hydrochloride

Active ingredients

Dexmethylphenidate hydrochloride — 20 mg/1

Dosage form

Capsule, Extended release

Route

Oral

Labeler

Novartis Pharmaceuticals CorporationNDC labeler code 0078

Product type

Prescription drug

Marketing category

NDA — New Drug ApplicationApplication NDA 021802

Marketing start

May 31, 2005

Marketing end

Dec 31, 2026

DEA schedule

CII

Other FDA classes

Central Nervous System Stimulation (Physiologic effect)

Identifiers

Product ID 0078-0432_fd5dd3b3-6bdf-437e-a763-1a07f9631121SPL ID fd5dd3b3-6bdf-437e-a763-1a07f9631121SPL set ID 1a1da905-42a0-4748-9c39-67eca45decccRxCUI 899439, 899441, 899461, 899463, 899485, 899487, 899495, 899497, 899511, 899513, 1006608, 1006610, 1101926, 1101928, 1101932, 1101934UNII 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

N400078043205 followed by a unit qualifier and the quantity Copy

Package 00078-0432-05. 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

About NDC 0078-0432

What is NDC 0078-0432?

0078-0432 is the product NDC for Focalin XR (dexmethylphenidate hydrochloride), Dexmethylphenidate hydrochloride 20 mg/1 capsule, extended release, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Focalin XR (Dexmethylphenidate hydrochloride).

What is the active ingredient?

Dexmethylphenidate hydrochloride.

Who is the labeler?

Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Focalin XR?

15 other product NDCs are listed under this name. See all Focalin XR NDCs.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory. See Billing references above.

Related NDCs: other Focalin XR products

Other finished products listed under the same name: strengths, forms and labelers.

All 16 Focalin XR NDCs

Other NDCs under NDA 021802

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