Focalin XR (Dexmethylphenidate hydrochloride) NDC 66758-237

Product information

Brand name (proprietary)

Focalin XRSuffix: XR

Generic name (nonproprietary)

dexmethylphenidate hydrochloride

Active ingredients

Dexmethylphenidate hydrochloride — 15 mg/1

Dosage form

Capsule, Extended release

Route

Oral

Labeler

Sandoz IncNDC labeler code 66758

Product type

Prescription drug

Marketing category

NDA — New Drug ApplicationApplication NDA 021802

Marketing start

May 31, 2005

Listing expires

Dec 31, 2026

DEA schedule

CII

Other FDA classes

Central Nervous System Stimulation (Physiologic effect)

Identifiers

Product ID 66758-237_525ad849-4502-493d-a0a1-67cde0a207f0SPL ID 525ad849-4502-493d-a0a1-67cde0a207f0SPL set ID 9cf76f62-48aa-4065-94fd-6fc910391ab5RxCUI 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

N466758023701 followed by a unit qualifier and the quantity Copy

Package 66758-0237-01. 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

About NDC 66758-237

What is NDC 66758-237?

66758-237 is the product NDC for Focalin XR (dexmethylphenidate hydrochloride), Dexmethylphenidate hydrochloride 15 mg/1 capsule, extended release, listed with the FDA by Sandoz Inc. It has 2 package NDCs, 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?

Sandoz Inc, NDC labeler code 66758. 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.