Nitazoxanide
- Product NDC
- 64980-526
- 11-digit product format
- 649800526
- Labeler code
- 64980
- Product ID
- 64980-526_9ee8087a-d001-42a9-ae98-6e4cbf93caa1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitazoxanide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA213820
- Marketing category
- ANDA
- Marketing start
- 2020-11-27
- Substance
- NITAZOXANIDE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Antiprotozoal [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nitazoxanide
- Listing expiration
- 2026-12-31
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 |
|---|
| 64980-526-03 | Nitazoxanide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
| 64980-526-21 | Nitazoxanide | 12 in 1 BOTTLE | TABLET, FILM COATED | 12 | | 9 |
| 64980-526-60 | Nitazoxanide | 6 in 1 BOTTLE | TABLET, FILM COATED | 6 | | 9 |
| 64980-526-81 | Nitazoxanide | 18 in 1 BOTTLE | TABLET, FILM COATED | 18 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-526 | NITAZOXANIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] | 8 | Current NDC, Legacy NDC, 4 package rows | 20250424_c0dc0656-3c46-43f9-adea-5285c522cef8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64980-526-03 | 64980052603 | 30 TABLET, FILM COATED in 1 BOTTLE (64980-526-03) | 2020-11-27 | 0000-00-00 | No | No | Current |
| 64980-526-21 | 64980052621 | 12 TABLET, FILM COATED in 1 BOTTLE (64980-526-21) | 2020-11-27 | 0000-00-00 | No | No | Current |
| 64980-526-60 | 64980052660 | 6 TABLET, FILM COATED in 1 BOTTLE (64980-526-60) | 2020-11-27 | 0000-00-00 | No | No | Current |
| 64980-526-81 | 64980052681 | 18 TABLET, FILM COATED in 1 BOTTLE (64980-526-81) | 2020-11-27 | 0000-00-00 | No | No | Current |