What is NDC 57664-378?

57664-378 is the product NDC for Dexmethylphenidate hydrochloride, Dexmethylphenidate hydrochloride 5 mg/1 tablet, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 57664. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dexmethylphenidate hydrochloride?

72 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dexmethylphenidate hydrochloride NDC 57664-378

NDC codes

FDA NDC Directory

Product NDC (as listed)57664-378Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57664-0378Add 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
57664-378-08	5766403780857664037808	100 TABLET in 1 BOTTLE (57664-378-08)Marketed from Sep 26, 2013
57664-378-13	5766403781357664037813	500 TABLET in 1 BOTTLE (57664-378-13)Marketed from Sep 26, 2013
57664-378-18	5766403781857664037818	1000 TABLET in 1 BOTTLE (57664-378-18)Marketed from Sep 26, 2013
57664-378-83	5766403788357664037883	30 TABLET in 1 BOTTLE (57664-378-83)Marketed from Sep 26, 2013
57664-378-88	5766403788857664037888	100 TABLET in 1 BOTTLE (57664-378-88)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 — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 57664
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 57664-378_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

N457664037808 followed by a unit qualifier and the quantity

Package 57664-0378-08. 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

Current FDA label (SPL), effective Jan 2, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Dexmethylphenidate hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )] . Dexmethylphenidate hydrochloride tablets are 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)

About NDC 57664-378

What is NDC 57664-378?: 57664-378 is the product NDC for Dexmethylphenidate hydrochloride, Dexmethylphenidate hydrochloride 5 mg/1 tablet, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dexmethylphenidate hydrochloride.
What is the active ingredient?: Dexmethylphenidate hydrochloride.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 57664. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dexmethylphenidate hydrochloride?: 72 other product NDCs are listed under this name. See all Dexmethylphenidate hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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

Other Dexmethylphenidate hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride 5 mg/1	TabletOral	Bryant Ranch Prepack	72162-2426	72162-2426-0172162-2426-06
Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride 10 mg/1	TabletOral	Bryant Ranch Prepack	72162-2427	72162-2427-01
Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride 5 mg/1	TabletOral	Nivagen Pharmaceuticals, Inc.	75834-327	75834-0327-01
Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride 10 mg/1	TabletOral	Nivagen Pharmaceuticals, Inc.	75834-328	75834-0328-01
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 5 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-229	31722-0229-01
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 10 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-230	31722-0230-01
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 15 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-231	31722-0231-01
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 20 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-232	31722-0232-01
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 25 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-233	31722-0233-01
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 30 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-234	31722-0234-01

All 73 Dexmethylphenidate hydrochloride NDCs

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 2.5 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	57664-376
Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride 10 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	57664-379