NYSTATIN
- Product NDC
- 17856-0508
- 11-digit product format
- 178560508
- Labeler code
- 17856
- Product ID
- 17856-0508_484acdef-5f40-bd3e-e063-6394a90aebe2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NYSTATIN
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Application
- ANDA214346
- Marketing category
- ANDA
- Marketing start
- 2022-12-05
- Substance
- NYSTATIN
- Active strength
- 100000 [USP'U]/mL
- Pharmacologic classes
- Polyene Antifungal [EPC], Polyenes [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NYSTATIN
- Listing expiration
- 2027-12-31
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 |
|---|
| 17856-0508-1 | NYSTATIN | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | | 3 |
| 17856-0508-1 | NYSTATIN | 72 in 1 BOX, UNIT-DOSE | SUSPENSION | 72 | | 3 |
| 17856-0508-3 | NYSTATIN | 5 mL in 1 SYRINGE | SUSPENSION | 5 | | 3 |
| 17856-0508-3 | NYSTATIN | 48 in 1 BOX, UNIT-DOSE | SUSPENSION | 48 | | 3 |
| 17856-0508-5 | NYSTATIN | 48 in 1 BOX, UNIT-DOSE | SUSPENSION | 48 | | 3 |
| 17856-0508-5 | NYSTATIN | 5 mL in 1 SYRINGE | SUSPENSION | 5 | | 3 |
| 17856-0508-7 | NYSTATIN | 1 mL in 1 SYRINGE | SUSPENSION | 1 | | 3 |
| 17856-0508-7 | NYSTATIN | 120 in 1 BOX, UNIT-DOSE | SUSPENSION | 120 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17856-0508 | NYSTATIN SUSPENSION [ATLANTIC BIOLOGICALS CORP.] | 2 | Current NDC, 8 package rows | 20240719_5c08148f-83e5-4f14-b0d3-af8d2c26062e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 17856-0508-1 | 17856050801 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0508-1) / 5 mL in 1 CUP, UNIT-DOSE | | 2024-07-15 | No | No | Current |
| 17856-0508-3 | 17856050803 | 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-3) / 5 mL in 1 SYRINGE | 48 syringe | 2024-07-17 | No | No | Current |
| 17856-0508-5 | 17856050805 | 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-5) / 5 mL in 1 SYRINGE | 48 syringe | 2024-07-17 | No | No | Current |
| 17856-0508-7 | 17856050807 | 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-7) / 1 mL in 1 SYRINGE | 120 syringe | 2024-07-17 | No | No | Current |