Dexmethylphenidate hydrochloride NDC 57664-376

NDC codes

FDA NDC Directory

Product NDC (as listed)57664-376Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57664-0376Add 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
57664-376-08	57664037608	100 TABLET in 1 BOTTLE (57664-376-08)Marketed from Sep 26, 2013
57664-376-13	57664037613	500 TABLET in 1 BOTTLE (57664-376-13)Marketed from Sep 26, 2013
57664-376-18	57664037618	1000 TABLET in 1 BOTTLE (57664-376-18)Marketed from Sep 26, 2013
57664-376-83	57664037683	30 TABLET in 1 BOTTLE (57664-376-83)Marketed from Sep 26, 2013
57664-376-88	57664037688	100 TABLET in 1 BOTTLE (57664-376-88)Marketed from Sep 26, 2013

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 — 2.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201231
Marketing start: Sep 26, 2013
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 57664-376_0d0cbfc3-ae27-b481-e063-6394a90a917cSPL ID 0d0cbfc3-ae27-b481-e063-6394a90a917cSPL set ID 987b4983-1edc-40f1-adc9-724747080969RxCUI 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

N457664037608 followed by a unit qualifier and the quantity

Package 57664-0376-08. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 201231

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

FDA NDC Directory listings under ANDA 201231
Product	Strength	Form · route	Labeler	Product NDC
Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride 10 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	57664-379
Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride 5 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	57664-378