NDC 70010-034 – Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate
Dextroamphetamine Saccharate 7.5 mg/1; Amphetamine Aspartate Monohydrate 7.5 mg/1; Dextroamphetamine Sulfate 7.5 mg/1; Amphetamine Sulfate 7.5 mg/1 · Capsule, Extended Release · Oral
Product NDC70010-034
Product details
- Brand name
- Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate
- Generic name
- Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate
- Labeler
- Granules Pharmaceuticals Inc.
- Dosage form
- Capsule, Extended Release
- Route
- Oral
- Marketing category
- ANDA · ANDA217027
- Marketed since
- February 20, 2023
- 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 Saccharate 7.5 mg/1
- Amphetamine Aspartate Monohydrate 7.5 mg/1
- Dextroamphetamine Sulfate 7.5 mg/1
- Amphetamine Sulfate 7.5 mg/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 70010-034-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-034-01) | Feb 20, 2023 |
Recalls mentioning this NDC
- D-0671-2025 Oct 1, 2025 · Class III
Failed Impurities/Degradation Specifications: - D-0673-2025 Oct 1, 2025 · Class III
Failed Impurities/Degradation Specifications: - D-0672-2025 Oct 1, 2025 · Class III
Failed Impurities/Degradation Specifications: - D-0670-2025 Oct 1, 2025 · Class III
Failed Impurities/Degradation Specifications: - D-0669-2025 Oct 1, 2025 · Class III
Failed Impurities/Degradation Specifications:
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