Prescription drug · ANDA
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate NDC 0228-3061
Dextroamphetamine saccharate 7.5 mg/1 + 3 more ingredients · Capsule, Extended release · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0228-3061-11 | 00228306111 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3061-11)Marketed from Jun 22, 2012 |
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, amphetamine sulfate
- Generic name (nonproprietary)
- dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
- Active ingredients
- Dextroamphetamine saccharate — 7.5 mg/1Amphetamine aspartate monohydrate — 7.5 mg/1Dextroamphetamine sulfate — 7.5 mg/1Amphetamine sulfate — 7.5 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077302
- 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 0228-3061_a90e80bb-ff5a-4665-b0ad-66cca29c86d1SPL ID a90e80bb-ff5a-4665-b0ad-66cca29c86d1SPL set ID c5c2d060-452c-4f76-ad93-2e41fd8f06c2RxCUI 861221, 861223, 861225, 861227, 861232, 861237UNII O1ZPV620O4, G83415V073, 6DPV8NK46S, JJ768O327NUPC 0302283059110, 0302283064114, 0302283063117
- 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
N400228306111followed by a unit qualifier and the quantityPackage 00228-3061-11. 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, 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, amphetamine sulfate extended-release capsules are 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, 8.4)…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077302
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, amphetamine sulfate | Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 0228-3059 |
| Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate | Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 0228-3060 |
| Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate | Dextroamphetamine saccharate 1.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 0228-3062 |
| Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate | Dextroamphetamine saccharate 3.75 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 0228-3063 |
| Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate | Dextroamphetamine saccharate 6.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 0228-3064 |