Prescription drug · ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate NDC 0527-0793
Dextroamphetamine sulfate 5 mg/1 + 3 more ingredients · Capsule, Extended release · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-0793-37 | 00527079337 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-0793-37)Marketed from Nov 26, 2021 |
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 Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
- Generic name (nonproprietary)
- dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate
- Active ingredients
- Dextroamphetamine sulfate — 5 mg/1Dextroamphetamine saccharate — 5 mg/1Amphetamine aspartate monohydrate — 5 mg/1Amphetamine sulfate — 5 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Lannett Company, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214403
- 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 0527-0793_84f9b61a-9585-46d5-bade-fa9c4e3e8d99SPL ID 84f9b61a-9585-46d5-bade-fa9c4e3e8d99SPL set ID e95bdaf9-007a-4088-b969-fee38a97a475RxCUI 861221, 861223, 861225, 861227, 861232, 861237UNII O1ZPV620O4, G83415V073, 6DPV8NK46S, JJ768O327NUPC 0305270791376, 0305870193310, 0305270790379, 0305270794377
- 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
N400527079337followed by a unit qualifier and the quantityPackage 00527-0793-37. 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, are 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.…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214403
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 Sulfatedextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 3.75 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Lannett Company, Inc. | 0527-0792 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfatedextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 1.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Lannett Company, Inc. | 0527-0790 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfatedextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 2.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-558 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfatedextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 1.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-557 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfatedextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 7.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-562 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfatedextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 3.75 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-559 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfatedextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-560 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfatedextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Amphetamine sulfate 6.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-561 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfatedextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 2.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Lannett Company, Inc. | 0527-0791 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfatedextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 6.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Lannett Company, Inc. | 0527-0794 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfatedextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 7.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Lannett Company, Inc. | 0527-0795 |