Nystatin
- Product NDC
- 0121-1045
- 11-digit product format
- 001211045
- Labeler code
- 0121
- Product ID
- 0121-1045_4901e044-ed1c-4f55-add3-c33e1399f91a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NYSTATIN
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA203621
- Marketing category
- ANDA
- Marketing start
- 2024-06-21
- Substance
- NYSTATIN
- Active strength
- 100000 [USP'U]/mL
- Pharmacologic classes
- Polyene Antifungal [EPC], Polyenes [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nystatin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NYSTATIN | 100000 [USP'U]/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | BDF1O1C72E |
| Rxcui | 312055 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e29fe634-dc25-094c-c77f-5d09c3eceb3e | Product name | 5 | 20260107 |
| 4b7700e3-6e0e-45e5-9d22-6f754d61386e | Product name | 2 | 20250304 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| e57b6340-9387-3f9a-7307-511c81791375 | Product name | 3 | 20221214 |
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| 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 |
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0121-1045-16 | Nystatin | 473 mL in 1 BOTTLE | SUSPENSION | 473 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-1045-16 | ML - Milliliter | 0121-1045 | e343bae4-f68c-4ae6-bad6-4d96cd809527 | 1 | 2024-08-12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312055 | nystatin 100,000 UNT/mL Oral Suspension | PSN | 2e7fadda-5f16-4be6-b6bb-985fafe3a1f3 | 3 |
| 312055 | nystatin 100000 UNT/ML Oral Suspension | SCD | 2e7fadda-5f16-4be6-b6bb-985fafe3a1f3 | 3 |
| 312055 | nystatin 100,000 UNT/ML Oral Suspension | SY | 2e7fadda-5f16-4be6-b6bb-985fafe3a1f3 | 3 |
| 312055 | nystatin 500,000 UNT per 5 ML Oral Suspension | SY | 2e7fadda-5f16-4be6-b6bb-985fafe3a1f3 | 3 |
| 312055 | nystatin 100,000 UNT/mL Oral Suspension | PSN | 05a8b8b6-3639-47b8-b7fc-47b105f5e6f9 | 1 |
| 312055 | nystatin 100000 UNT/ML Oral Suspension | SCD | 05a8b8b6-3639-47b8-b7fc-47b105f5e6f9 | 1 |
| 312055 | nystatin 100,000 UNT/ML Oral Suspension | SY | 05a8b8b6-3639-47b8-b7fc-47b105f5e6f9 | 1 |
| 312055 | nystatin 500,000 UNT per 5 ML Oral Suspension | SY | 05a8b8b6-3639-47b8-b7fc-47b105f5e6f9 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0121-1045-16 | 00121104516 | 473 mL in 1 BOTTLE (0121-1045-16) | 473 ml | 2024-06-21 | No | No | Historical |