NDC 0555-0776 – Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dextroamphetamine Saccharate 3.125 mg/1; Amphetamine Aspartate Monohydrate 3.125 mg/1; Dextroamphetamine Sulfate 3.125 mg/1; Amphetamine Sulfate 3.125 mg/1 · Tablet · Oral
Product NDC0555-0776
Product details
- Brand name
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
- Generic name
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Dosage form
- Tablet
- Route
- Oral
- Marketing category
- ANDA · ANDA040422
- Marketed since
- March 19, 2003
- Listing expires
- December 31, 2026
- Pharmacologic class
- Central Nervous System Stimulant; Central Nervous System Stimulant; Central Nervous System Stimulant; Central Nervous System Stimulant
Active ingredients
- Dextroamphetamine Saccharate 3.125 mg/1
- Amphetamine Aspartate Monohydrate 3.125 mg/1
- Dextroamphetamine Sulfate 3.125 mg/1
- Amphetamine Sulfate 3.125 mg/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 0555-0776-02 | 100 TABLET in 1 BOTTLE (0555-0776-02) | Mar 19, 2003 |
Recalls mentioning this NDC
- D-1539-2022 Sep 21, 2022 · Class II
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product. - D-1285-2020 Jun 10, 2020 · Class II
Some bottles may contain mixed strengths of the product. - D-1287-2020 Jun 10, 2020 · Class II
Some bottles may contain mixed strengths of the product. - D-1286-2020 Jun 10, 2020 · Class II
Some bottles may contain mixed strengths of the product. - D-0566-2016 Jan 20, 2016 · Class II
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing. - D-1283-2015 Aug 12, 2015 · Class II
Failed Impurities/Degradation Specifications: out of specification for unknown impurity - D-0050-2015 Nov 5, 2014 · Class II
Failed Impurities/Degradation Specifications: Out of specification for unknown impurities. - D-1094-2014 Mar 12, 2014 · Class II
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished…
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