Dextroamphetamine Sulfate Extended-Release NDC 0406-8960

NDC codes

FDA NDC Directory

Product NDC (as listed)0406-8960Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00406-8960Add 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
0406-8960-01	00406896001	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8960-01)Marketed from May 6, 2003

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): Dextroamphetamine Sulfate Extended-ReleaseSuffix: Extended-Release
Generic name (nonproprietary): dextroamphetamine sulfate
Active ingredients: Dextroamphetamine sulfate — 5 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: SpecGx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076353
Marketing start: May 6, 2003
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 0406-8960_78bafc02-003f-497f-b8c0-2bb063b3fa35SPL ID 78bafc02-003f-497f-b8c0-2bb063b3fa35SPL set ID 69c40af8-3710-46bf-bd3d-137fe5eea23eRxCUI 884520, 884532, 884535UNII JJ768O327NUPC 0304068962011, 0304068961014, 0304068960017
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

N400406896001 followed by a unit qualifier and the quantity

Package 00406-8960-01. 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 Dec 8, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Dextroamphetamine sulfate extended-release capsules are indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of the hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., sc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076353

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

FDA NDC Directory listings under ANDA 076353
Product	Strength	Form · route	Labeler	Product NDC
Dextroamphetamine Sulfate Extended-Releasedextroamphetamine sulfate	Dextroamphetamine sulfate 10 mg/1	Capsule, Extended releaseOral	SpecGx LLC	0406-8961
Dextroamphetamine Sulfate Extended-Releasedextroamphetamine sulfate	Dextroamphetamine sulfate 15 mg/1	Capsule, Extended releaseOral	SpecGx LLC	0406-8962