Nystatin
- Product NDC
- 13668-534
- 11-digit product format
- 136680534
- Labeler code
- 13668
- Product ID
- 13668-534_b5c975a5-4d7a-4177-b1e2-524bad92a5fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA211838
- Marketing category
- ANDA
- Marketing start
- 2019-01-29
- Substance
- NYSTATIN
- Active strength
- 100000 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 U/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BDF1O1C72E |
| Rxcui | 884308 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13668-534-01 | Nystatin | 15 g in 1 TUBE | OINTMENT | 15 | | 8 |
| 13668-534-02 | Nystatin | 30 g in 1 TUBE | OINTMENT | 30 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-534 | NYSTATIN OINTMENT [TORRENT PHARMACEUTICALS LIMITED] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241208_4949dea7-d2b9-4e0d-974a-39408fa174ba.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 |
|---|
| 13668-534-01 | 13668053401 | 15 g in 1 TUBE (13668-534-01) | 15 g | 2019-01-29 | 0000-00-00 | No | No | Current |
| 13668-534-02 | 13668053402 | 30 g in 1 TUBE (13668-534-02) | 30 g | 2019-01-29 | 0000-00-00 | No | No | Current |