Prescription drug · ANDA
Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate NDC 0406-8884
Dextroamphetamine saccharate 1.875 mg/1 + 3 more ingredients · Tablet · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-8884-01 | 00406888401 | 100 TABLET in 1 BOTTLE (0406-8884-01)Marketed from Oct 7, 2003 |
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 and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate
- Generic name (nonproprietary)
- dextroamphetamine saccharate and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfate
- Active ingredients
- Dextroamphetamine saccharate — 1.875 mg/1Amphetamine aspartate monohydrate — 1.875 mg/1Dextroamphetamine sulfate — 1.875 mg/1Amphetamine sulfate — 1.875 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- SpecGx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040440
- 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 0406-8884_0d3fb5ba-ff79-4862-bc1d-45b8343e115bSPL ID 0d3fb5ba-ff79-4862-bc1d-45b8343e115bSPL set ID 72ddd1c9-ddbd-4c95-acd9-003189a353a3RxCUI 541363, 541878, 541892, 577957, 577961, 1009145UNII JJ768O327N, O1ZPV620O4, 6DPV8NK46S, G83415V073UPC 0304068885013, 0304068892011, 0304068893018, 0304068891014, 0304068884016, 0304068894015
- 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
N400406888401followed by a unit qualifier and the quantityPackage 00406-8884-01. 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)
INDICATIONS AND USAGE Mixed Salts of a Single Entity Amphetamine Product are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV ® ) implies the presence of 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 two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Ina…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040440
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.