NDC 0121-0868 – Nystatin
Nystatin 100000 [USP'U]/mL · Suspension · Oral
Product NDC0121-0868
Product details
- Brand name
- Nystatin
- Generic name
- Nystatin
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Dosage form
- Suspension
- Route
- Oral
- Marketing category
- ANDA · ANDA203621
- Marketed since
- July 17, 2020
- Listing expires
- December 31, 2027
- Pharmacologic class
- Polyene Antifungal
Active ingredients
- Nystatin 100000 [USP'U]/mL
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 0121-0868-00 | 10 TRAY in 1 CASE (0121-0868-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05) | Jul 17, 2020 |
| 0121-0868-02 | 60 mL in 1 BOTTLE, DROPPER (0121-0868-02) | Jul 17, 2020 |
| 0121-0868-16 | 473 mL in 1 BOTTLE (0121-0868-16) | Jul 17, 2020 |
| 0121-0868-50 | 5 TRAY in 1 CASE (0121-0868-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05) | Jul 17, 2020 |
Recalls mentioning this NDC
- D-0721-2021 Aug 18, 2021 · Class II
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
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