Prescription drug · ANDA
Dextroamphetamine Sulfate Extended-Release (Dextroamphetamine sulfate) NDC 0406-8962
Dextroamphetamine sulfate 15 mg/1 · Capsule, Extended release · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-8962-01 | 00406896201 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8962-01)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 — 15 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- SpecGx LLCNDC labeler code 0406
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076353
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0406-8962_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
N400406896201followed by a unit qualifier and the quantityPackage 00406-8962-01. 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 . 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.
About NDC 0406-8962
- What is NDC 0406-8962?
- 0406-8962 is the product NDC for Dextroamphetamine Sulfate Extended-Release, Dextroamphetamine sulfate 15 mg/1 capsule, extended release, listed with the FDA by SpecGx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dextroamphetamine Sulfate Extended-Release (Dextroamphetamine sulfate).
- What is the active ingredient?
- Dextroamphetamine sulfate.
- Who is the labeler?
- SpecGx LLC, NDC labeler code 0406. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dextroamphetamine Sulfate Extended-Release?
- 5 other product NDCs are listed under this name. See all Dextroamphetamine Sulfate Extended-Release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dextroamphetamine Sulfate Extended-Release products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dextroamphetamine Sulfate Extended-Releasedextroamphetamine sulfate | Dextroamphetamine sulfate 5 mg/1 | Capsule, Extended releaseOral | SpecGx LLC | 0406-8960 | 00406-8960-01 |
| Dextroamphetamine Sulfate Extended-Releasedextroamphetamine sulfate | Dextroamphetamine sulfate 10 mg/1 | Capsule, Extended releaseOral | SpecGx LLC | 0406-8961 | 00406-8961-01 |
| Dextroamphetamine Sulfate Extended-Releasedextroamphetamine sulfate | Dextroamphetamine sulfate 5 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-9927 | 00115-9927-10 |
| Dextroamphetamine Sulfate Extended-Releasedextroamphetamine sulfate | Dextroamphetamine sulfate 10 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-9928 | 00115-9928-10 |
| Dextroamphetamine Sulfate Extended-Releasedextroamphetamine sulfate | Dextroamphetamine sulfate 15 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-9929 | 00115-9929-10 |
Other NDCs under ANDA 076353
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dextroamphetamine Sulfate Extended-Releasedextroamphetamine sulfate | Dextroamphetamine sulfate 5 mg/1 | Capsule, Extended releaseOral | SpecGx LLC | 0406-8960 |
| Dextroamphetamine Sulfate Extended-Releasedextroamphetamine sulfate | Dextroamphetamine sulfate 10 mg/1 | Capsule, Extended releaseOral | SpecGx LLC | 0406-8961 |