NDC 0527-0793 – Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dextroamphetamine Sulfate 5 mg/1; Dextroamphetamine Saccharate 5 mg/1; Amphetamine Aspartate Monohydrate 5 mg/1; Amphetamine Sulfate 5 mg/1 · Capsule, Extended Release · Oral
Product NDC0527-0793
Product details
- Brand name
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
- Generic name
- Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
- Labeler
- Lannett Company, Inc.
- Dosage form
- Capsule, Extended Release
- Route
- Oral
- Marketing category
- ANDA · ANDA214403
- Marketed since
- November 26, 2021
- Listing expires
- December 31, 2027
- Pharmacologic class
- Central Nervous System Stimulant; Central Nervous System Stimulant; Central Nervous System Stimulant; Central Nervous System Stimulant
Active ingredients
- Dextroamphetamine Sulfate 5 mg/1
- Dextroamphetamine Saccharate 5 mg/1
- Amphetamine Aspartate Monohydrate 5 mg/1
- Amphetamine Sulfate 5 mg/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 0527-0793-37 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-0793-37) | Nov 26, 2021 |
Recalls mentioning this NDC
- D-0660-2026 Jul 8, 2026 · Class II
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
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