Nystatin Cream
- Product NDC
- 0316-0221
- 11-digit product format
- 003160221
- Labeler code
- 0316
- Product ID
- 0316-0221_48342e66-405b-57be-e063-6394a90a276c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin Cream
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Crown Laboratories
- Application
- ANDA207733
- Marketing category
- ANDA
- Marketing start
- 2017-10-10
- 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 Cream
- 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 | 543546 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0316-0221-15 | Nystatin Cream | 1 in 1 CARTON | CREAM | 1 | | 8 |
| 0316-0221-15 | Nystatin Cream | 15 g in 1 TUBE | CREAM | 15 | | 8 |
| 0316-0221-30 | Nystatin Cream | 1 in 1 CARTON | CREAM | 1 | | 8 |
| 0316-0221-30 | Nystatin Cream | 30 g in 1 TUBE | CREAM | 30 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0316-0221 | NYSTATIN CREAM CREAM [CROWN LABORATORIES] | 6 | Current NDC, Legacy NDC, 4 package rows | 20231025_5a2b6fee-1437-0c3a-e053-2991aa0a3443.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0316-0221-15 | 00316022115 | 1 TUBE in 1 CARTON (0316-0221-15) / 15 g in 1 TUBE | 1 tube | 2017-10-10 | 0000-00-00 | No | No | Current |
| 0316-0221-30 | 00316022130 | 1 TUBE in 1 CARTON (0316-0221-30) / 30 g in 1 TUBE | 1 tube | 2017-10-10 | 0000-00-00 | No | No | Current |