Prescription drug · ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate NDC 64850-512
Dextroamphetamine saccharate 3.75 mg/1 + 3 more ingredients · Capsule, Extended release · Oral · Elite Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64850-512-01 | 64850051201 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64850-512-01)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 — 3.75 mg/1Dextroamphetamine sulfate — 3.75 mg/1Amphetamine aspartate monohydrate — 3.75 mg/1Amphetamine sulfate — 3.75 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Elite Laboratories, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212037
- 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 64850-512_36306a4d-071c-4838-8b16-d5522034bfd5SPL ID 36306a4d-071c-4838-8b16-d5522034bfd5SPL set ID 084c625c-94c6-4c8a-ba5f-6e26206dd903RxCUI 861221, 861223, 861225, 861227, 861232, 861237UNII JJ768O327N, O1ZPV620O4, 6DPV8NK46S, G83415V073UPC 0364850511018, 0364850510011, 0364850515016, 0364850513012, 0364850514019, 0364850512015
- 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
N464850051201followed by a unit qualifier and the quantityPackage 64850-0512-01. 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 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) Limitations of Use The use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. ( 5.5 ,…
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 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 5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Burel Pharmaceuticals, LLC | 35573-467 |
| 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 |