Nystatin
- Product NDC
- 82804-045
- 11-digit product format
- 828040045
- Labeler code
- 82804
- Product ID
- 82804-045_8566c432-741f-4af7-91d7-1b7668ce5e95
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Proficient Rx LP
- Application
- ANDA212557
- Marketing category
- ANDA
- Marketing start
- 2019-07-24
- Substance
- NYSTATIN
- Active strength
- 100000 U/g
- 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 U/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BDF1O1C72E |
| Rxcui | 543546 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-045-15 | Nystatin | 15 g in 1 TUBE | CREAM | 15 | | 1 |
| 82804-045-30 | Nystatin | 30 g in 1 TUBE | CREAM | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-045 | NYSTATIN CREAM [PROFICIENT RX LP] | 1 | Current NDC, 2 package rows | 20231212_8566c432-741f-4af7-91d7-1b7668ce5e95.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 |
|---|
| 82804-045-15 | 82804004515 | 15 g in 1 TUBE (82804-045-15) | 15 g | 2023-12-08 | No | No | Current |
| 82804-045-30 | 82804004530 | 30 g in 1 TUBE (82804-045-30) | 30 g | 2023-12-08 | No | No | Current |