Prescription drug · ANDA
dextroamphetamine sulfate NDC 45963-305
Dextroamphetamine sulfate 15 mg/1 · Capsule, Extended release · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45963-305-09 | 45963030509 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-305-09)Marketed from Jun 19, 2014 |
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)
- dextroamphetamine sulfate
- Generic name (nonproprietary)
- dextroamphetamine sulfate
- Active ingredients
- Dextroamphetamine sulfate — 15 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203901
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 45963-305_efcdbc4d-7174-4356-9aa2-d557735e2048SPL ID efcdbc4d-7174-4356-9aa2-d557735e2048SPL set ID 9e92ccc3-d81c-461d-a19f-7e9b582be357RxCUI 884520, 884532, 884535UNII JJ768O327NUPC 0345963305091, 0345963304094, 0345963303097
- 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
N445963030509followed by a unit qualifier and the quantityPackage 45963-0305-09. 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.
Other NDCs under ANDA 203901
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 | Dextroamphetamine sulfate 10 mg/1 | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 45963-304 |
| dextroamphetamine sulfate | Dextroamphetamine sulfate 5 mg/1 | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 45963-303 |