What is NDC 0115-9921?

0115-9921 is the product NDC for Dexmethylphenidate hydrochloride, Dexmethylphenidate hydrochloride 20 mg/1 capsule, extended release, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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 0115-9921

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-9921Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-9921Add 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
0115-9921-01	0011599210100115992101	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-9921-01)Marketed from Dec 21, 2015

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
Generic name (nonproprietary): dexmethylphenidate hydrochloride
Active ingredients: Dexmethylphenidate hydrochloride — 20 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079108
Marketing start: Dec 21, 2015
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 0115-9921_4fcd36f9-1e85-437f-9f27-0e2942480c7fSPL ID 4fcd36f9-1e85-437f-9f27-0e2942480c7fSPL set ID 93e56455-0f15-4ed9-a63a-7fbd0697d520RxCUI 899439, 899461, 899485, 899495, 899511UNII 1678OK0E08UPC 0301159919015, 0301159918018, 0301159921018, 0301159922015, 0301159920011
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

N400115992101 followed by a unit qualifier and the quantity

Package 00115-9921-01. 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 Oct 9, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14) ] . Limitations of Use The use of dexmethylphenidate 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) ]. Dexmethylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Atte…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0115-9921

What is NDC 0115-9921?: 0115-9921 is the product NDC for Dexmethylphenidate hydrochloride, Dexmethylphenidate hydrochloride 20 mg/1 capsule, extended release, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, 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?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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 079108

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

FDA NDC Directory listings under ANDA 079108
Product	Strength	Form · route	Labeler	Product NDC
Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride 5 mg/1	Capsule, Extended releaseOral	Amneal Pharmaceuticals of New York LLC	0115-9918
Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride 10 mg/1	Capsule, Extended releaseOral	Amneal Pharmaceuticals of New York LLC	0115-9919
Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride 15 mg/1	Capsule, Extended releaseOral	Amneal Pharmaceuticals of New York LLC	0115-9920
Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride 30 mg/1	Capsule, Extended releaseOral	Amneal Pharmaceuticals of New York LLC	0115-9922