Prescription drug · ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate NDC 0115-1490
Dextroamphetamine saccharate 6.25 mg/1 + 3 more ingredients · Capsule · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0115-1490-01 | 00115149001 | 100 CAPSULE in 1 BOTTLE (0115-1490-01)Marketed from Feb 16, 2016 |
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 Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
- Generic name (nonproprietary)
- dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
- Active ingredients
- Dextroamphetamine saccharate — 6.25 mg/1Amphetamine aspartate monohydrate — 6.25 mg/1Dextroamphetamine sulfate — 6.25 mg/1Amphetamine sulfate — 6.25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076852
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0115-1490_ce289645-272b-4036-a807-2077a3927e9fSPL ID ce289645-272b-4036-a807-2077a3927e9f
- 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
N400115149001followed by a unit qualifier and the quantityPackage 00115-1490-01. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 076852
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 Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 0115-1487 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 3.75 mg/1 + 3 more ingredients | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 0115-1488 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 0115-1489 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 7.5 mg/1 + 3 more ingredients | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 0115-1491 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 1.25 mg/1 + 3 more ingredients | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 0115-1486 |