Prescription drug · ANDA
Mixed Salts of a Single Entity Amphetamine Product XR NDC 0406-8954
Dextroamphetamine sulfate 5 mg/1 + 3 more ingredients · Capsule, Extended release · Oral · SpecGx LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0406-8954Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00406-8954Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-8954-01 | 0040689540100406895401 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8954-01)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 — 5 mg/1Dextroamphetamine saccharate — 5 mg/1Amphetamine aspartate monohydrate — 5 mg/1Amphetamine sulfate — 5 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 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 0406-8954_28a6fbe6-9500-4f14-9e12-041e302a0a24SPL ID 28a6fbe6-9500-4f14-9e12-041e302a0a24
- 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
N400406895401followed by a unit qualifier and the quantityPackage 00406-8954-01. 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.
About NDC 0406-8954
- What is NDC 0406-8954?
- 0406-8954 is the product NDC for Mixed Salts of a Single Entity Amphetamine Product XR, Dextroamphetamine sulfate 5 mg/1 + 3 more ingredients 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?
- Mixed Salts of a Single Entity Amphetamine Product XR (Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate).
- What is the active ingredient?
- Dextroamphetamine sulfate, Dextroamphetamine saccharate, Amphetamine aspartate monohydrate, Amphetamine 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 Mixed Salts of a Single Entity Amphetamine Product XR?
- 5 other product NDCs are listed under this name. See all Mixed Salts of a Single Entity Amphetamine Product XR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mixed Salts of a Single Entity Amphetamine Product XR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| 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 | 00406-8951-01 |
| Mixed Salts of a Single Entity Amphetamine Product XRdextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate | Dextroamphetamine sulfate 2.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | SpecGx LLC | 0406-8952 | 00406-8952-01 |
| 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 | 00406-8953-01 |
| 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 | 00406-8955-01 |
| 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 | 00406-8956-01 |
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 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 2.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | SpecGx LLC | 0406-8952 |
| 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 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 |