Prescription drug · ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate NDC 35573-467
Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients · Capsule, Extended release · Oral · Burel Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35573-467-02 | 35573046702 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-467-02)Marketed from Dec 16, 2019 |
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 Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
- Generic name (nonproprietary)
- dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
- Active ingredients
- Dextroamphetamine saccharate — 5 mg/1Dextroamphetamine sulfate — 5 mg/1Amphetamine aspartate monohydrate — 5 mg/1Amphetamine sulfate — 5 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Burel Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212037
- 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 35573-467_01fe666a-d04e-4dce-af71-8db45bbde653SPL ID 01fe666a-d04e-4dce-af71-8db45bbde653SPL set ID bcdd2fe2-d0de-4a28-aced-40ac9ce5122dRxCUI 861221, 861223, 861225, 861227, 861232, 861237UNII JJ768O327N, O1ZPV620O4, 6DPV8NK46S, G83415V073UPC 0335573466022, 0335573468026, 0335573467029
- 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
N435573046702followed by a unit qualifier and the quantityPackage 35573-0467-02. 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 and amphetamine sulfate extended-release 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 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release 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 ANDA 212037
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 Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine saccharate 3.75 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Elite Laboratories, Inc. | 64850-512 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine saccharate 1.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Elite Laboratories, Inc. | 64850-510 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Elite Laboratories, Inc. | 64850-511 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine saccharate 7.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Elite Laboratories, Inc. | 64850-515 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Elite Laboratories, Inc. | 64850-513 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine saccharate 6.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Elite Laboratories, Inc. | 64850-514 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine saccharate 1.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Burel Pharmaceuticals, LLC | 35573-464 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine saccharate 6.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Burel Pharmaceuticals, LLC | 35573-468 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Burel Pharmaceuticals, LLC | 35573-465 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine saccharate 3.75 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Burel Pharmaceuticals, LLC | 35573-466 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine saccharate 7.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Burel Pharmaceuticals, LLC | 35573-469 |