Prescription drug · NDA AUTHORIZED GENERIC

Dexmethylphenidate Hydrochloride Extended-Release NDC 0781-2728

dexmethylphenidate hydrochloride · Dexmethylphenidate hydrochloride 10 mg/1 · Capsule, Extended release · Oral · Sandoz Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)0781-2728Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-2728Add 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
0781-2728-310078127283130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2728-31)Marketed from Sep 24, 2026

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Extended-ReleaseSuffix: Extended-Release
Generic name (nonproprietary)
dexmethylphenidate hydrochloride
Active ingredients
Dexmethylphenidate hydrochloride — 10 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Labeler
Sandoz Inc
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 021802
Marketing start
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 0781-2728_71f56227-d87a-4bc0-a879-c1993c6ccba6SPL ID 71f56227-d87a-4bc0-a879-c1993c6ccba6

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

N400781272831 followed by a unit qualifier and the quantity

Package 00781-2728-31. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under NDA 021802

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

FDA NDC Directory listings under NDA 021802
ProductStrengthForm · routeLabelerProduct NDC
Focalin XRdexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 35 mg/1Capsule, Extended releaseOralNovartis Pharmaceuticals Corporation0078-0609
Focalin XRdexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 40 mg/1Capsule, Extended releaseOralNovartis Pharmaceuticals Corporation0078-0434
Focalin XRdexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 25 mg/1Capsule, Extended releaseOralNovartis Pharmaceuticals Corporation0078-0608
Focalin XRdexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 20 mg/1Capsule, Extended releaseOralNovartis Pharmaceuticals Corporation0078-0432
Focalin XRdexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 15 mg/1Capsule, Extended releaseOralNovartis Pharmaceuticals Corporation0078-0493
Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 15 mg/1Capsule, Extended releaseOralSandoz Inc0781-2729
Focalin XRdexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 5 mg/1Capsule, Extended releaseOralNovartis Pharmaceuticals Corporation0078-0430
Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 20 mg/1Capsule, Extended releaseOralSandoz Inc0781-2730
Focalin XRdexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 15 mg/1Capsule, Extended releaseOralSandoz Inc66758-237
Focalin XRdexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 5 mg/1Capsule, Extended releaseOralSandoz Inc66758-235
Focalin XRdexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 10 mg/1Capsule, Extended releaseOralSandoz Inc66758-236
Focalin XRdexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 35 mg/1Capsule, Extended releaseOralSandoz Inc66758-241
Focalin XRdexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 20 mg/1Capsule, Extended releaseOralSandoz Inc66758-238
Focalin XRdexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 25 mg/1Capsule, Extended releaseOralSandoz Inc66758-239
Focalin XRdexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 30 mg/1Capsule, Extended releaseOralSandoz Inc66758-240
Focalin XRdexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 40 mg/1Capsule, Extended releaseOralSandoz Inc66758-242
Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 5 mg/1Capsule, Extended releaseOralSandoz Inc0781-2727
Focalin XRdexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 30 mg/1Capsule, Extended releaseOralNovartis Pharmaceuticals Corporation0078-0433
Focalin XRdexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 10 mg/1Capsule, Extended releaseOralNovartis Pharmaceuticals Corporation0078-0431

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NDC 0781-2728 | Med-Code