NDC 43975-281 – Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Amphetamine Sulfate 6.25 mg/1; Amphetamine Dl-aspartate Monohydrate 6.25 mg/1; Dextroamphetamine Sulfate 6.25 mg/1; Dextroamphetamine Saccharate 6.25 mg/1 · Capsule, Extended Release · Oral
Product NDC43975-281
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
- ANI Pharmaceuticals, Inc.
- Dosage form
- Capsule, Extended Release
- Route
- Oral
- Marketing category
- ANDA · ANDA205401
- Marketed since
- March 16, 2020
- 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
- Amphetamine Sulfate 6.25 mg/1
- Amphetamine Dl-aspartate Monohydrate 6.25 mg/1
- Dextroamphetamine Sulfate 6.25 mg/1
- Dextroamphetamine Saccharate 6.25 mg/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 43975-281-10 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-281-10) | Mar 16, 2020 |
Recalls mentioning this NDC
- D-0044-2021 Oct 28, 2020 · Class III
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. - D-0047-2021 Oct 28, 2020 · Class III
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. - D-0046-2021 Oct 28, 2020 · Class III
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. - D-0045-2021 Oct 28, 2020 · Class III
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. - D-0043-2021 Oct 28, 2020 · Class III
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. - D-0048-2021 Oct 28, 2020 · Class III
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
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