What is NDC 0781-2383?

0781-2383 is the product NDC for Methylphenidate, Methylphenidate hydrochloride 10 mg/1 capsule, extended release, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Methylphenidate?

13 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Methylphenidate NDC 0781-2383 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-2383Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-2383Add 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	Copy
0781-2383-01	0078123830100781238301	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2383-01)Marketed from Mar 3, 2025

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): Methylphenidate
Generic name (nonproprietary): methylphenidate
Active ingredients: Methylphenidate hydrochloride — 10 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Sandoz IncNDC labeler code 0781
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021284
Marketing start: Nov 24, 2015
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 0781-2383_ade65b90-a3e4-4df4-a066-b72f161dc306SPL ID ade65b90-a3e4-4df4-a066-b72f161dc306SPL set ID 44386394-d2a3-4483-abe1-6c5c634cc501RxCUI 1806177, 1806179, 1806183, 1806195UNII 4B3SC438HI
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

N400781238301 followed by a unit qualifier and the quantity

Package 00781-2383-01. 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

Current FDA label (SPL), effective Sep 23, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies ( 14 )] . Limitations of Use The use of methylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7 ), Use in Specific Populations ( 8.4 )]. Methylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimula…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-2383

What is NDC 0781-2383?: 0781-2383 is the product NDC for Methylphenidate, Methylphenidate hydrochloride 10 mg/1 capsule, extended release, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Methylphenidate.
What is the active ingredient?: Methylphenidate hydrochloride.
Who is the labeler?: Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Methylphenidate?: 13 other product NDCs are listed under this name. See all Methylphenidate 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 Methylphenidate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Methylphenidate	Methylphenidate 1.1 mg/h	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-8260	00378-8260-93
Methylphenidate	Methylphenidate 1.6 mg/h	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-8261	00378-8261-93
Methylphenidate	Methylphenidate 2.2 mg/h	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-8262	00378-8262-93
Methylphenidate	Methylphenidate 3.3 mg/h	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-8263	00378-8263-93
Methylphenidatemethylphenidate hydrochloride	Methylphenidate hydrochloride 5 mg/5mL	SolutionOral	KVK-Tech, Inc.	10702-163	10702-0163-50
Methylphenidatemethylphenidate hydrochloride	Methylphenidate hydrochloride 10 mg/5mL	SolutionOral	KVK-Tech, Inc.	10702-164	10702-0164-50
Methylphenidate	Methylphenidate hydrochloride 10 mg/1	Capsule, Extended releaseOral	Sandoz Inc	0781-2361	—
Methylphenidate	Methylphenidate hydrochloride 20 mg/1	Capsule, Extended releaseOral	Sandoz Inc	0781-2362	00781-2362-01
Methylphenidate	Methylphenidate hydrochloride 30 mg/1	Capsule, Extended releaseOral	Sandoz Inc	0781-2363	00781-2363-01
Methylphenidate	Methylphenidate hydrochloride 40 mg/1	Capsule, Extended releaseOral	Sandoz Inc	0781-2364	00781-2364-01

All 14 Methylphenidate NDCs

Other NDCs under NDA 021284

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

FDA NDC Directory listings under NDA 021284
Product	Strength	Form · route	Labeler	Product NDC
Methylphenidate	Methylphenidate hydrochloride 10 mg/1	Capsule, Extended releaseOral	Sandoz Inc	0781-2361
Methylphenidate	Methylphenidate hydrochloride 20 mg/1	Capsule, Extended releaseOral	Sandoz Inc	0781-2362
Methylphenidate	Methylphenidate hydrochloride 30 mg/1	Capsule, Extended releaseOral	Sandoz Inc	0781-2363
Methylphenidate	Methylphenidate hydrochloride 40 mg/1	Capsule, Extended releaseOral	Sandoz Inc	0781-2364
Methylphenidate	Methylphenidate hydrochloride 20 mg/1	Capsule, Extended releaseOral	Sandoz Inc	0781-2384
Methylphenidate	Methylphenidate hydrochloride 30 mg/1	Capsule, Extended releaseOral	Sandoz Inc	0781-2385
Methylphenidate	Methylphenidate hydrochloride 40 mg/1	Capsule, Extended releaseOral	Sandoz Inc	0781-2386
Ritalin LAmethylphenidate hydrochloride	Methylphenidate hydrochloride 20 mg/1	Capsule, Extended releaseOral	Novartis Pharmaceuticals Corporation	0078-0370
Ritalin LAmethylphenidate hydrochloride	Methylphenidate hydrochloride 30 mg/1	Capsule, Extended releaseOral	Novartis Pharmaceuticals Corporation	0078-0371
Ritalin LAmethylphenidate hydrochloride	Methylphenidate hydrochloride 40 mg/1	Capsule, Extended releaseOral	Novartis Pharmaceuticals Corporation	0078-0372
Ritalin LAmethylphenidate hydrochloride	Methylphenidate hydrochloride 10 mg/1	Capsule, Extended releaseOral	Novartis Pharmaceuticals Corporation	0078-0424