Nitazoxanide
- Product NDC
- 13517-135
- 11-digit product format
- 135170135
- Labeler code
- 13517
- Product ID
- 13517-135_db1d15c7-d9af-410f-98d5-bd6e8f84c815
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitazoxanide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- e5 Pharma, LLC
- Application
- ANDA214844
- Marketing category
- ANDA
- Marketing start
- 2026-01-26
- Substance
- NITAZOXANIDE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Antiprotozoal [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nitazoxanide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITAZOXANIDE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SOA12P041N |
| Rxcui | 427163 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13517-135-06 | Nitazoxanide | 6 in 1 BOTTLE | TABLET | 6 | | 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 |
|---|
| 13517-135-06 | 13517013506 | 6 TABLET in 1 BOTTLE (13517-135-06) | 6 tablet | 2026-01-26 | No | No | Current |