Prescription drug · NDA
Dexedrine Spansule (Dextroamphetamine sulfate) NDC 64896-673
Dextroamphetamine sulfate 5 mg/1 · Capsule, Extended release · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64896-673-10 | 64896067310 | 1 BOTTLE in 1 CARTON (64896-673-10) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLEMarketed from Aug 2, 1976 |
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)
- Dexedrine SpansuleSuffix: SPANSULE
- Generic name (nonproprietary)
- dextroamphetamine sulfate
- Active ingredients
- Dextroamphetamine sulfate — 5 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 64896
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017078
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 64896-673_d5d5a976-872f-4849-b222-1fb433511511SPL ID d5d5a976-872f-4849-b222-1fb433511511SPL set ID cc717b9b-22ea-4c60-a1d4-ee38a40bce78RxCUI 884520, 884528, 884532, 884534, 884535, 884537UNII JJ768O327N
- 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
N464896067310followed by a unit qualifier and the quantityPackage 64896-0673-10. 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 DEXEDRINE is 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., school (or work) and at home. The symptoms mu…
Excerpt only. Read the full label for complete information.
About NDC 64896-673
- What is NDC 64896-673?
- 64896-673 is the product NDC for Dexedrine Spansule (dextroamphetamine sulfate), Dextroamphetamine sulfate 5 mg/1 capsule, extended release, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dexedrine Spansule (Dextroamphetamine sulfate).
- What is the active ingredient?
- Dextroamphetamine sulfate.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 64896. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dexedrine Spansule?
- 2 other product NDCs are listed under this name. See all Dexedrine Spansule NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dexedrine Spansule products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dexedrine Spansuledextroamphetamine sulfate | Dextroamphetamine sulfate 10 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-674 | 64896-0674-10 |
| Dexedrine Spansuledextroamphetamine sulfate | Dextroamphetamine sulfate 15 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-675 | 64896-0675-10 |
Other NDCs under NDA 017078
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 |
|---|---|---|---|---|
| Dexedrine Spansuledextroamphetamine sulfate | Dextroamphetamine sulfate 10 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-674 |
| Dexedrine Spansuledextroamphetamine sulfate | Dextroamphetamine sulfate 15 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-675 |
| Dextroamphetamine Sulfate Extended-Releasedextroamphetamine sulfate | Dextroamphetamine sulfate 5 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-9927 |
| Dextroamphetamine Sulfate Extended-Releasedextroamphetamine sulfate | Dextroamphetamine sulfate 10 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-9928 |
| Dextroamphetamine Sulfate Extended-Releasedextroamphetamine sulfate | Dextroamphetamine sulfate 15 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-9929 |