Nystatin
- Product NDC
- 21695-643
- 11-digit product format
- 216950643
- Labeler code
- 21695
- Product ID
- 21695-643_29ccf947-91c1-405a-aba6-5889e3c75d70
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA065148
- Marketing category
- ANDA
- Marketing start
- 2005-06-28
- Marketing end
- 0000-00-00
- Substance
- NYSTATIN
- Active strength
- 100000 [USP'U]/mL
- Pharmacologic classes
- Polyene Antifungal [EPC],Polyenes [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e29fe634-dc25-094c-c77f-5d09c3eceb3e | Product name | 5 | 20260107 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| e57b6340-9387-3f9a-7307-511c81791375 | Product name | 3 | 20221214 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| 544f8e8d-6389-eeeb-9586-aa447c08dcc7 | Product name | 5 | 20210614 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 1629e00f-54fb-4a43-8306-b58442b23902 | Product name | 9 | 20200430 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 854ec07b-1cd7-a5db-235a-7aa24d3cf97a | Product name | 3 | 20180628 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 19b9f4c1-15e9-edcc-4c16-f01ecfb5c549 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-643-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4845-48b1-e053-8cdaa90a720a | NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-643-60 | Nystatin | 60 mL in 1 BOTTLE, DROPPER | SUSPENSION | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-643-60 | ML - Milliliter | 21695-643 | 20738cb3-086c-472e-b196-a47c69fed8bf | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312055 | nystatin 100,000 UNT/mL Oral Suspension | PSN | 29ccf947-91c1-405a-aba6-5889e3c75d70 | 1 |
| 312055 | nystatin 100000 UNT/ML Oral Suspension | SCD | 29ccf947-91c1-405a-aba6-5889e3c75d70 | 1 |
| 312055 | nystatin 100,000 UNT/ML Oral Suspension | SY | 29ccf947-91c1-405a-aba6-5889e3c75d70 | 1 |
| 312055 | nystatin 500,000 UNT per 5 ML Oral Suspension | SY | 29ccf947-91c1-405a-aba6-5889e3c75d70 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-643-60 | 21695064360 | 60 mL in 1 BOTTLE, DROPPER | 60 ml | Historical |