Prescription drug · ANDA
Mixed Salts of a Single-Entity Amphetamine Product NDC 0406-0803
Dextroamphetamine sulfate 6.25 mg/1 + 3 more ingredients · Capsule, Extended release · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-0803-01 | 0040608030100406080301 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0803-01)Marketed from Nov 1, 2023 |
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
- Generic name (nonproprietary)
- dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
- Active ingredients
- Dextroamphetamine sulfate — 6.25 mg/1Dextroamphetamine saccharate — 6.25 mg/1Amphetamine aspartate monohydrate — 6.25 mg/1Amphetamine sulfate — 6.25 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 211546
- 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 0406-0803_03d41c88-9c50-4406-91ba-7a086cad0366SPL ID 03d41c88-9c50-4406-91ba-7a086cad0366SPL set ID e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78RxCUI 1927610, 1927617, 1927630, 1927637UNII G83415V073, JJ768O327N, 6DPV8NK46S, O1ZPV620O4UPC 0304060804012, 0304060805019, 0304060807013, 0304060803015
- 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
N400406080301followed by a unit qualifier and the quantityPackage 00406-0803-01. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older [see Clinical Studies ( 14 )] . Limitations of Use: Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose, and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite [see Use in Specific Populations ( 8.4 )] . Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (AD…
Excerpt only. Read the full label for complete information.
About NDC 0406-0803
- What is NDC 0406-0803?
- 0406-0803 is the product NDC for Mixed Salts of a Single-Entity Amphetamine Product, Dextroamphetamine sulfate 6.25 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 (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?
- 3 other product NDCs are listed under this name. See all Mixed Salts of a Single-Entity Amphetamine Product 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 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 Productdextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate | Dextroamphetamine sulfate 12.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | SpecGx LLC | 0406-0804 | 00406-0804-01 |
| Mixed Salts of a Single-Entity Amphetamine Productdextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate | Dextroamphetamine sulfate 3.125 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | SpecGx LLC | 0406-0805 | 00406-0805-01 |
| Mixed Salts of a Single-Entity Amphetamine Productdextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate | Dextroamphetamine sulfate 9.375 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | SpecGx LLC | 0406-0807 | 00406-0807-01 |
Other NDCs under ANDA 211546
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 Productdextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate | Dextroamphetamine sulfate 12.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | SpecGx LLC | 0406-0804 |
| Mixed Salts of a Single-Entity Amphetamine Productdextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate | Dextroamphetamine sulfate 3.125 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | SpecGx LLC | 0406-0805 |
| Mixed Salts of a Single-Entity Amphetamine Productdextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate | Dextroamphetamine sulfate 9.375 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | SpecGx LLC | 0406-0807 |