NDC 50111-648 – Fluoxetine
Fluoxetine Hydrochloride 20 mg/1 · Capsule · Oral
Product NDC50111-648
Product details
- Brand name
- Fluoxetine
- Generic name
- Fluoxetine
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Dosage form
- Capsule
- Route
- Oral
- Marketing category
- ANDA · ANDA076001
- Marketed since
- January 29, 2002
- Listing expires
- December 31, 2026
- Pharmacologic class
- Serotonin Reuptake Inhibitor
Active ingredients
- Fluoxetine Hydrochloride 20 mg/1
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 50111-648-01 | 100 CAPSULE in 1 BOTTLE (50111-648-01) | Jan 29, 2002 |
| 50111-648-02 | 500 CAPSULE in 1 BOTTLE (50111-648-02) | Jan 29, 2002 |
| 50111-648-03 | 1000 CAPSULE in 1 BOTTLE (50111-648-03) | Jan 29, 2002 |
| 50111-648-44 | 2000 CAPSULE in 1 BOTTLE (50111-648-44) | Jan 29, 2002 |
Recalls mentioning this NDC
- D-0971-2015 May 6, 2015 · Class II
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity. - D-0970-2015 May 6, 2015 · Class II
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity. - D-1280-2014 May 7, 2014 · Class II
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. - D-1281-2014 May 7, 2014 · Class II
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
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