Nystatin
- Product NDC
- 42543-352
- 11-digit product format
- 425430352
- Labeler code
- 42543
- Product ID
- 42543-352_73b965b0-ddd8-477c-91db-fe40f154597f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin
- Dosage form
- POWDER
- Route
- TOPICAL
- Labeler
- Vensun Pharmaceuticals, Inc.
- Application
- ANDA065175
- Marketing category
- ANDA
- Marketing start
- 2018-07-06
- Marketing end
- 2022-03-31
- Substance
- NYSTATIN
- Active strength
- 100000 U/g
- Pharmacologic classes
- Polyene Antifungal [EPC],Polyenes [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42543-352-15 | 2020-03-05 | C162847 | 48780-1 | 9d75b9d0-bb24-f424-e053-dadaa90a57ce | 396724fe-2304-41f6-b5f9-c4917677ab93 |
| 42543-352-30 | 2020-03-05 | C162847 | 48780-1 | 9d75b9d0-bb24-f424-e053-dadaa90a57ce | 396724fe-2304-41f6-b5f9-c4917677ab93 |
| 42543-352-60 | 2020-03-05 | C162847 | 48780-1 | 9d75b9d0-bb24-f424-e053-dadaa90a57ce | 396724fe-2304-41f6-b5f9-c4917677ab93 |
| 42543-352-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bb24-f424-e053-dadaa90a57ce | 396724fe-2304-41f6-b5f9-c4917677ab93 |
| 42543-352-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bb24-f424-e053-dadaa90a57ce | 396724fe-2304-41f6-b5f9-c4917677ab93 |
| 42543-352-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bb24-f424-e053-dadaa90a57ce | 396724fe-2304-41f6-b5f9-c4917677ab93 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42543-352-15 | GM - Gram | 42543-352 | 74768757-e76b-4dcc-8c8d-4c40be0d7adc | 1 | 2018-09-05 |
| 42543-352-30 | GM - Gram | 42543-352 | 96a022e5-0e08-437d-9510-5b2cd04f19b1 | 1 | 2018-09-05 |
| 42543-352-60 | GM - Gram | 42543-352 | be62a97a-7747-4b1c-b85a-225807e4813f | 1 | 2018-09-05 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 42543-352-15 | 42543035215 | 100000 g in 1 BOTTLE (42543-352-15) | 100000 g | 2018-07-06 | 2022-03-31 | No | No | Current |
| 42543-352-30 | 42543035230 | 100000 g in 1 BOTTLE (42543-352-30) | 100000 g | 2018-07-06 | 2022-03-31 | No | No | Current |
| 42543-352-60 | 42543035260 | 100000 g in 1 BOTTLE (42543-352-60) | 100000 g | 2018-07-06 | 2022-03-31 | No | No | Current |