NDC 43975-281
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate 4 ingredients capsule, extended release
On the label: ANI Pharmaceuticals, Inc..
Where it's made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants ANI Pharmaceuticals, Inc. names for other drugs.
Recalls
- Oct 9, 2020 · Class III · ANI Pharmaceuticals, Inc.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Lots: Lot: 19S07 Exp. Sept. 2021 - Oct 9, 2020 · Class III · ANI Pharmaceuticals, Inc.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Lots: Lot: 19S10 Exp. Sept. 2021, 19S11 Exp. Oct. 2021 - Oct 9, 2020 · Class III · ANI Pharmaceuticals, Inc.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Lots: Lot: 19T14 Exp. Dec. 2021, 20D06 Exp. Apr. 2022 - Oct 9, 2020 · Class III · ANI Pharmaceuticals, Inc.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Lots: Lot: 19T15 Exp. Dec. 2021, 20D02, 20D03 Exp. Mar. 2022 - Oct 9, 2020 · Class III · ANI Pharmaceuticals, Inc.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Lots: Lot: 19T16 Exp. Jan. 2022 - Oct 9, 2020 · Class III · ANI Pharmaceuticals, Inc.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Lots: Lot: 19T17 Exp. Dec. 2021, 19T18, 19T19, Exp. Jan. 2022; 20D05 Exp. Apr. 2022; 20D21, Exp. May 2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Amphetamine and Dextroamphetamine: every company that makes it
- Form
- capsule, extended release, oral
- Strength
- 4 ingredients
- Approval
- ANDA ANDA205401
- On the market since
- Mar 16, 2020
- Package NDCs
43975-281-10- Official label
- DailyMed (National Library of Medicine), updated May 15, 2026
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