Nystatin
- Product NDC
- 0472-0166
- 11-digit product format
- 004720166
- Labeler code
- 0472
- Product ID
- 0472-0166_6a5c1ca5-b727-4129-b884-fa7d3eb2cd8f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA062840
- Marketing category
- ANDA
- Marketing start
- 2002-09-03
- Substance
- NYSTATIN
- Active strength
- 100000 [USP'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 [USP'U]/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BDF1O1C72E |
| Rxcui | 884308 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0472-0166-15 | 2024-02-06 | C162847 | 48780-1 | 1030e365-02d3-111a-e063-dadaa90a10e2 | NYSTATIN OINTMENT, USP (100,000 units/g) |
| 0472-0166-30 | 2024-02-06 | C162847 | 48780-1 | 1030e365-02d3-111a-e063-dadaa90a10e2 | NYSTATIN OINTMENT, USP (100,000 units/g) |
| 0472-0166-15 | 2024-01-30 | C162847 | 48780-1 | 1030e365-02d3-111a-e063-dadaa90a10e2 | NYSTATIN OINTMENT, USP (100,000 units/g) |
| 0472-0166-30 | 2024-01-30 | C162847 | 48780-1 | 1030e365-02d3-111a-e063-dadaa90a10e2 | NYSTATIN OINTMENT, USP (100,000 units/g) |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0472-0166-15 | Nystatin | 15 g in 1 TUBE | OINTMENT | 15 | | 8 |
| 0472-0166-15 | Nystatin | 1 in 1 CARTON | OINTMENT | 1 | | 8 |
| 0472-0166-30 | Nystatin | 30 g in 1 TUBE | OINTMENT | 30 | | 8 |
| 0472-0166-30 | Nystatin | 1 in 1 CARTON | OINTMENT | 1 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0472-0166 | NYSTATIN OINTMENT [ACTAVIS PHARMA, INC.] | 7 | Current NDC, Legacy NDC, 4 package rows | 20240207_aee7ce4c-8cc6-4446-a4d7-63bc4773066f.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 |
|---|
| 0472-0166-15 | 00472016615 | 1 TUBE in 1 CARTON (0472-0166-15) / 15 g in 1 TUBE | 1 tube | 2002-09-03 | 0000-00-00 | No | No | Current |
| 0472-0166-30 | 00472016630 | 1 TUBE in 1 CARTON (0472-0166-30) / 30 g in 1 TUBE | 1 tube | 2002-09-03 | 0000-00-00 | No | No | Current |