Prescription drug · ANDA
Mixed Salts of a Single Entity Amphetamine Product XR NDC 0406-8952
Dextroamphetamine sulfate 2.5 mg/1 + 3 more ingredients · Capsule, Extended release · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-8952-01 | 00406895201 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8952-01)Marketed from Apr 22, 2019 |
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)
- Mixed Salts of a Single Entity Amphetamine Product XRSuffix: XR
- Generic name (nonproprietary)
- dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
- Active ingredients
- Dextroamphetamine sulfate — 2.5 mg/1Dextroamphetamine saccharate — 2.5 mg/1Amphetamine aspartate monohydrate — 2.5 mg/1Amphetamine sulfate — 2.5 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 211547
- 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 0406-8952_d35f2f82-b0de-4f2a-a740-3d95c364cd7bSPL ID d35f2f82-b0de-4f2a-a740-3d95c364cd7bSPL set ID 60a2834c-38a2-480e-b89c-563e9cf0c9c3RxCUI 861221, 861223, 861225, 861227, 861232, 861237UNII JJ768O327N, O1ZPV620O4, 6DPV8NK46S, G83415V073UPC 0304068956010, 0304068955013
- 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
N400406895201followed by a unit qualifier and the quantityPackage 00406-8952-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 211547
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 |
|---|---|---|---|---|
| Mixed Salts of a Single Entity Amphetamine Product XRdextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate | Dextroamphetamine sulfate 6.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | SpecGx LLC | 0406-8955 |
| Mixed Salts of a Single Entity Amphetamine Product XRdextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate | Dextroamphetamine sulfate 7.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | SpecGx LLC | 0406-8956 |
| Mixed Salts of a Single Entity Amphetamine Product XRdextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate | Dextroamphetamine sulfate 1.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | SpecGx LLC | 0406-8951 |
| Mixed Salts of a Single Entity Amphetamine Product XRdextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate | Dextroamphetamine sulfate 3.75 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | SpecGx LLC | 0406-8953 |
| Mixed Salts of a Single Entity Amphetamine Product XRdextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate | Dextroamphetamine sulfate 5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | SpecGx LLC | 0406-8954 |