Nystatin
- Product NDC
- 55154-4314
- 11-digit product format
- 551544314
- Labeler code
- 55154
- Product ID
- 55154-4314_c6dbde35-e0a0-4f55-be3e-471aeb0b0302
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NYSTATIN
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA203621
- Marketing category
- ANDA
- Marketing start
- 2020-07-17
- 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 table| Ingredient | Strength |
|---|
| NYSTATIN | 100000 [USP'U]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BDF1O1C72E |
| Rxcui | 312055 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-4314-5 | Nystatin | 5 in 1 BAG | SUSPENSION | 5 | | 4 |
| 55154-4314-5 | Nystatin | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-4314 | NYSTATIN SUSPENSION [CARDINAL HEALTH 107, LLC] | 3 | Current NDC, 2 package rows | 20241025_56aca0e2-8691-4701-beba-e2315524709f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55154-4314-5 | 55154431405 | 5 CUP, UNIT-DOSE in 1 BAG (55154-4314-5) / 5 mL in 1 CUP, UNIT-DOSE | 2023-08-01 | No | No | Historical |