Nystatin
- Product NDC
- 50383-587
- 11-digit product format
- 503830587
- Labeler code
- 50383
- Product ID
- 50383-587_0345456c-d63b-4692-9640-f7aae6171ad7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Akorn
- Application
- ANDA064042
- Marketing category
- ANDA
- Marketing start
- 2012-01-27
- Marketing end
- 0000-00-00
- Substance
- NYSTATIN
- Active strength
- 100000 [USP'U]/mL
- Pharmacologic classes
- Polyene Antifungal [EPC], Polyenes [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e29fe634-dc25-094c-c77f-5d09c3eceb3e | Product name | 5 | 20260107 |
| e57b6340-9387-3f9a-7307-511c81791375 | Product name | 3 | 20221214 |
| 544f8e8d-6389-eeeb-9586-aa447c08dcc7 | Product name | 5 | 20210614 |
| 1629e00f-54fb-4a43-8306-b58442b23902 | Product name | 9 | 20200430 |
| 854ec07b-1cd7-a5db-235a-7aa24d3cf97a | Product name | 3 | 20180628 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 19b9f4c1-15e9-edcc-4c16-f01ecfb5c549 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50383-587-16 | ML - Milliliter | 50383-587 | aaac5690-86c2-4a39-8258-14113544d743 | 1 | 2012-07-24 |
| 50383-587-66 | ML - Milliliter | 50383-587 | 3534ff37-b61d-4e86-8aa7-40546e3c223b | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312055 | nystatin 100,000 UNT/mL Oral Suspension | PSN | 8ce02e76-303c-4e06-a47e-0a7bbf46c3f2 | 1 |
| 312055 | nystatin 100000 UNT/ML Oral Suspension | SCD | 8ce02e76-303c-4e06-a47e-0a7bbf46c3f2 | 1 |
| 312055 | nystatin 100,000 UNT/ML Oral Suspension | SY | 8ce02e76-303c-4e06-a47e-0a7bbf46c3f2 | 1 |
| 312055 | nystatin 500,000 UNT per 5 ML Oral Suspension | SY | 8ce02e76-303c-4e06-a47e-0a7bbf46c3f2 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50383-587-16 | 50383058716 | 473 mL in 1 BOTTLE (50383-587-16) | 473 ml | 2012-01-27 | 0000-00-00 | No | No | Current |
| 50383-587-66 | 50383058766 | 1 BOTTLE, DROPPER in 1 CARTON (50383-587-66) > 60 mL in 1 BOTTLE, DROPPER | 2012-01-27 | 0000-00-00 | No | No | Current |