Prescription drug · ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate NDC 11534-192
Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients · Tablet · Oral · SUNRISE PHARMACEUTICAL, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11534-192-01 | 11534019201 | 100 TABLET in 1 BOTTLE (11534-192-01)Marketed from Jul 4, 2018 | |
| 11534-192-03 | 11534019203 | 1000 TABLET in 1 BOTTLE (11534-192-03)Marketed from Jul 4, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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, Dextroamphetamine Sulfate And Amphetamine Sulfate
- Generic name (nonproprietary)
- dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
- Active ingredients
- Dextroamphetamine saccharate — 2.5 mg/1Amphetamine aspartate monohydrate — 2.5 mg/1Dextroamphetamine sulfate — 2.5 mg/1Amphetamine sulfate — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- SUNRISE PHARMACEUTICAL, INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209799
- 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 11534-192_60dcfbf6-d07a-4010-ae77-8a9ae4529828SPL ID 60dcfbf6-d07a-4010-ae77-8a9ae4529828SPL set ID ac102599-3a5b-4154-899e-6ff262be7ff7RxCUI 541363, 541878, 541892, 577957, 577961, 687043, 1009145UNII O1ZPV620O4, G83415V073, 6DPV8NK46S, JJ768O327NUPC 0311534193039, 0311534192032, 0311534191035, 0311534196016, 0311534190038, 0311534196030, 0311534195033
- 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
N411534019201followed by a unit qualifier and the quantityPackage 11534-0192-01. 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 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single 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 (o…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209799
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, Dextroamphetamine Sulfate And Amphetamine Sulfate | Dextroamphetamine saccharate 1.875 mg/1 + 3 more ingredients | TabletOral | Bryant Ranch Prepack | 72162-1235 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Dextroamphetamine saccharate 3.125 mg/1 + 3 more ingredients | TabletOral | Bryant Ranch Prepack | 72162-1236 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Dextroamphetamine saccharate 1.25 mg/1 + 3 more ingredients | TabletOral | SUNRISE PHARMACEUTICAL, INC. | 11534-190 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Dextroamphetamine saccharate 1.875 mg/1 + 3 more ingredients | TabletOral | SUNRISE PHARMACEUTICAL, INC. | 11534-191 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Dextroamphetamine saccharate 3.125 mg/1 + 3 more ingredients | TabletOral | SUNRISE PHARMACEUTICAL, INC. | 11534-193 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Dextroamphetamine saccharate 3.75 mg/1 + 3 more ingredients | TabletOral | SUNRISE PHARMACEUTICAL, INC. | 11534-194 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients | TabletOral | SUNRISE PHARMACEUTICAL, INC. | 11534-195 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Dextroamphetamine saccharate 7.5 mg/1 + 3 more ingredients | TabletOral | SUNRISE PHARMACEUTICAL, INC. | 11534-196 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients | TabletOral | Bryant Ranch Prepack | 72162-2251 |