Prescription drug · NDA AUTHORIZED GENERIC
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate NDC 0781-2352
Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients · Capsule, Extended release · Oral · Sandoz Inc
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0781-2352Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-2352Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-2352-01 | 00781235201 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2352-01)Marketed from Apr 2, 2009 |
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, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
- Generic name (nonproprietary)
- dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
- Active ingredients
- Dextroamphetamine saccharate — 5 mg/1Amphetamine aspartate monohydrate — 5 mg/1Dextroamphetamine sulfate — 5 mg/1Amphetamine sulfate — 5 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021303
- Marketing start
- Marketing end
- 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 0781-2352_11936c1c-41a8-481c-b12f-dcc5837968d2SPL ID 11936c1c-41a8-481c-b12f-dcc5837968d2SPL set ID 6f637e8d-7c2e-47fa-a43c-3250c51aed77RxCUI 861221, 861223, 861225, 861227, 861232, 861237UNII JJ768O327N, O1ZPV620O4, 6DPV8NK46S, G83415V073UPC 0307812352014, 0307812335017, 0307812343012, 0307812368015, 0307812371015, 0307812329016
- 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
N400781235201followed by a unit qualifier and the quantityPackage 00781-2352-01. 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)
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE extended-release capsules (MAS-ER Capsules), a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. ( 1 ) 1.1 Attention Deficit Hyperactivity Disorder MAS-ER Capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021303
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 Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Sandoz Inc | 0781-2335 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 3.75 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Sandoz Inc | 0781-2343 |
| Adderall XRdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 7.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-391 |
| Adderall XRdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 3.75 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-385 |
| Adderall XRdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-387 |
| Adderall XRdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 6.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-389 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 6.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Sandoz Inc | 0781-2368 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 7.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Sandoz Inc | 0781-2371 |
| Adderall XRdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 2.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-383 |
| Adderall XRdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 1.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-381 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Prasco Laboratories | 66993-595 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 1.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Prasco Laboratories | 66993-594 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 6.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Prasco Laboratories | 66993-598 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 3.75 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Prasco Laboratories | 66993-596 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Prasco Laboratories | 66993-597 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 7.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Prasco Laboratories | 66993-599 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 1.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Sandoz Inc | 0781-2329 |