Prescription drug · ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate NDC 68462-651
Amphetamine sulfate 3.75 mg/1 + 3 more ingredients · Tablet · Oral · GLENMARK PHARMACEUTICALS INC., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-651-01 | 68462065101 | 100 TABLET in 1 BOTTLE (68462-651-01)Marketed from May 12, 2025 |
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, Amphetamine Sulfate
- Generic name (nonproprietary)
- dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate
- Active ingredients
- Amphetamine sulfate — 3.75 mg/1Amphetamine dl-aspartate — 3.75 mg/1Dextroamphetamine saccharate — 3.75 mg/1Dextroamphetamine sulfate — 3.75 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210754
- 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)
- Identifiers
- Product ID 68462-651_a586519f-97a3-4a3a-951a-c3ecaab95334SPL ID a586519f-97a3-4a3a-951a-c3ecaab95334SPL set ID 4564e404-8d71-4585-ab78-55857f477143RxCUI 541363, 541878, 541892, 577957, 577961UNII G83415V073, 6DPV8NK46S, JJ768O327N, H527KAP6L5UPC 0368462653012, 0368462651018, 0368462649015, 0368462652015, 0368462647011
- 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
N468462065101followed by a unit qualifier and the quantityPackage 68462-0651-01. 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 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210754
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, Amphetamine Sulfate | Dextroamphetamine sulfate 1.25 mg/1 + 3 more ingredients | TabletOral | GLENMARK PHARMACEUTICALS INC., USA | 68462-647 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate | Dextroamphetamine sulfate 7.5 mg/1 + 3 more ingredients | TabletOral | GLENMARK PHARMACEUTICALS INC., USA | 68462-653 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate | Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients | TabletOral | GLENMARK PHARMACEUTICALS INC., USA | 68462-649 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate | Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients | TabletOral | GLENMARK PHARMACEUTICALS INC., USA | 68462-652 |