NDC 0121-0810 – Nystatin
Nystatin 100000 [USP'U]/mL · Suspension · Oral
Product NDC0121-0810
Product details
- Brand name
- Nystatin
- Generic name
- Nystatin
- Labeler
- Pharmaceutical Associates, Inc.
- Dosage form
- Suspension
- Route
- Oral
- Marketing category
- ANDA · ANDA203621
- Marketed since
- February 1, 2016
- Listing expires
- December 31, 2026
- Pharmacologic class
- Polyene Antifungal
Active ingredients
- Nystatin 100000 [USP'U]/mL
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 0121-0810-02 | 60 mL in 1 BOTTLE, DROPPER (0121-0810-02) | Feb 1, 2016 |
| 0121-0810-16 | 473 mL in 1 BOTTLE (0121-0810-16) | Feb 1, 2016 |
Recalls mentioning this NDC
- D-1494-2020 Aug 19, 2020 · Class II
Subpotent drug: Out of specification for assay at the 15-month test interval. - D-1060-2020 Apr 1, 2020 · Class II
SubPotent Drug: Low out-of-specification results for assay testing. - D-0824-2020 Feb 5, 2020 · Class II
Subpotent: Out of specification for assay at the 12-month time point. - D-0865-2018 Jun 13, 2018 · Class III
Resuspension problems: Out of specification for appearance and resuspendability.
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