Nystatin
- Product NDC
- 72603-491
- 11-digit product format
- 726030491
- Labeler code
- 72603
- Product ID
- 72603-491_e7bbfa6e-9723-4309-97d3-76fe9a0cfde6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin
- Dosage form
- POWDER
- Route
- TOPICAL
- Labeler
- Northstar Rx LLC
- Application
- ANDA064118
- Marketing category
- ANDA
- Marketing start
- 2025-09-01
- Substance
- NYSTATIN
- Active strength
- 100000 [USP'U]/g
- 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]/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BDF1O1C72E |
| Rxcui | 646456 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72603-491-01 | Nystatin | 15 g in 1 BOTTLE, PLASTIC | POWDER | 15 | | 2 |
| 72603-491-02 | Nystatin | 30 g in 1 BOTTLE, PLASTIC | POWDER | 30 | | 2 |
| 72603-491-03 | Nystatin | 60 g in 1 BOTTLE, PLASTIC | POWDER | 60 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72603-491-01 | 72603049101 | 15 g in 1 BOTTLE, PLASTIC (72603-491-01) | 15 g | 2025-09-01 | No | No | Historical |
| 72603-491-02 | 72603049102 | 30 g in 1 BOTTLE, PLASTIC (72603-491-02) | 30 g | 2025-09-01 | No | No | Historical |
| 72603-491-03 | 72603049103 | 60 g in 1 BOTTLE, PLASTIC (72603-491-03) | 60 g | 2025-09-01 | No | No | Historical |